$NNVC
NANOVIRICIDES, INC.

2024 Q4 Form 10-Q Financial Statement

#000141057824001991 Filed on November 14, 2024

View on sec.gov

Income Statement

Concept 2024 Q4 2024 Q3
Revenue $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin
YoY Change
% of Gross Profit
Research & Development $1.933M
YoY Change 31.8%
% of Gross Profit
Depreciation & Amortization $193.5K
YoY Change 3.47%
% of Gross Profit
Operating Expenses $3.168M
YoY Change 55.93%
Operating Profit -$3.168M
YoY Change 55.93%
Interest Expense
YoY Change
% of Operating Profit
Other Income/Expense, Net $41.02K
YoY Change -34.72%
Pretax Income
YoY Change
Income Tax
% Of Pretax Income
Net Earnings -$3.100M
YoY Change 55.0%
Net Earnings / Revenue
Basic Earnings Per Share -$0.23
Diluted Earnings Per Share -$0.23
COMMON SHARES
Basic Shares Outstanding 14.35M 14.68M
Diluted Shares Outstanding 13.72M

Balance Sheet

Concept 2024 Q4 2024 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments
YoY Change
Cash & Equivalents $3.900M
Short-Term Investments
Other Short-Term Assets
YoY Change
Inventory
Prepaid Expenses $175.1K
Receivables
Other Receivables
Total Short-Term Assets $4.041M
YoY Change -43.42%
LONG-TERM ASSETS
Property, Plant & Equipment $7.366M
YoY Change -7.09%
Goodwill
YoY Change
Intangibles $323.2K
YoY Change -2.49%
Long-Term Investments
YoY Change
Other Assets
YoY Change
Total Long-Term Assets $7.699M
YoY Change -6.95%
TOTAL ASSETS
Total Short-Term Assets $4.041M
Total Long-Term Assets $7.699M
Total Assets $11.74M
YoY Change -23.85%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable
YoY Change
Accrued Expenses $283.3K
YoY Change -16.59%
Deferred Revenue
YoY Change
Short-Term Debt
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $1.633M
YoY Change 72.17%
LONG-TERM LIABILITIES
Long-Term Debt
YoY Change
Other Long-Term Liabilities
YoY Change
Total Long-Term Liabilities
YoY Change
TOTAL LIABILITIES
Total Short-Term Liabilities $1.633M
Total Long-Term Liabilities
Total Liabilities $1.633M
YoY Change -33.3%
SHAREHOLDERS EQUITY
Retained Earnings -$142.5M
YoY Change 7.1%
Common Stock $140.00
YoY Change 19.66%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $10.11M
YoY Change
Total Liabilities & Shareholders Equity $11.74M
YoY Change -23.85%

Cashflow Statement

Concept 2024 Q4 2024 Q3
OPERATING ACTIVITIES
Net Income -$3.100M
YoY Change 55.0%
Depreciation, Depletion And Amortization $193.5K
YoY Change 3.47%
Cash From Operating Activities -$2.600M
YoY Change 116.67%
INVESTING ACTIVITIES
Capital Expenditures $46.76K
YoY Change 464.03%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities -$46.76K
YoY Change 367.64%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 1.710M
YoY Change
NET CHANGE
Cash From Operating Activities -2.600M
Cash From Investing Activities -46.76K
Cash From Financing Activities 1.710M
Net Change In Cash -936.6K
YoY Change -21.95%
FREE CASH FLOW
Cash From Operating Activities -$2.600M
Capital Expenditures $46.76K
Free Cash Flow -$2.647M
YoY Change 119.05%

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<p style="font-family:'Times New Roman','Times','serif';font-size:10pt;font-weight:bold;text-align:justify;margin:0pt 0pt 12pt 0pt;">Note 1 – Organization and Nature of Business</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">NanoViricides, Inc. (the “Company”) is a clinical stage nano-biopharmaceutical company specializing in the discovery, development, and commercialization of drugs to combat viral infections using its unique and novel nanomedicines technology. NanoViricides possesses its own facility that supports research and development and drug discovery, drug candidate optimization, cGMP-compliant drug substance manufacturing, cGMP-compliant manufacturing and packaging of drug products for human clinical trials, and early commercialization. The Company has several drugs in various stages of development.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">NanoViricides, Inc. is domiciled under the laws of the State of Delaware, with its principal operations located in the State of Connecticut. The Company’s fiscal year begins on July 1<sup style="font-size:7.5pt;line-height:100%;top:0pt;vertical-align:top;">st</sup> and ends on the next June 30<sup style="font-size:7.5pt;line-height:100%;top:0pt;vertical-align:top;">th</sup> of the calendar year. The Company operates in one reportable business segment.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">The Company devotes substantially all its activity to advancing research and development, including efforts in connection with clinical trials. The Company’s lead drug candidate is the active pharmaceutical ingredient (API) NV-387. NV-387 is a broad-spectrum antiviral drug that has demonstrated strong activity in lethal lung infection animal model studies and is being developed to treat Coronavirus, RSV, Influenza and even an Orthopoxvirus model for Smallpox and MPox. The Company plans on developing NV-387 first as a treatment of RSV infection in pediatric patients.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">At present, NV-387 is in a Phase Ia/Ib human clinical trial for safety and tolerability in healthy subjects for the treatment of COVID-19, sponsored by our licensee and collaborator in India, Karveer Meditech Privale Limited (“KMPL”). All subjects have been discharged and follow-up visits have been completed as of approximately the end of December 2023. As topline results of this clinical trial, there were no reported adverse events at all doses studied, and there were no drop-outs either, observations that are indicative of tolerability of the API NV-387. These results are consistent with the results of safety/tolerability studies in animals conducted in support of the clinical trial application. The Company is awaiting the final study report from this clinical trial for further regulatory advancement of NV-387 into a Phase II clinical trial.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">The Company is now working on developing the necessary datasets, documentation, and clinical trial pathway and trial designs, for a Phase II clinical trial application for the use of NV-387 for the treatment of RSV infection, as the Phase Ia/Ib study progresses into the data analysis phase.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">On August 14, 2024, the WHO declared a Public Health Emergency of International Concern (PHEIC) regarding the expanding epidemic of MPox infections in Central Africa. There is no drug currently available for the treatment of MPox. NV-387 has been found to possess activity against orthopoxvirus infection in animal model studies, making it a viable candidate for clinical trial as a treatment for MPox infection under the MEURI (“Monitored Emergency Use of Unregistered and Investigational Interventions”) WHO protocol. The Company is now in the process of defining a clinical protocol for such a Phase II clinical trial with its collaborators in preparation for a clinical trial application to the appropriate regulatory agency.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">Subsequent to the MPOx and RSV Phase II clinical trials that are at high priority, the Company plans on expanding the indications of NV-387 to other respiratory viral infections including Influenzas, Coronaviruses, and others.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">Additionally, the Company has previously developed a clinical drug candidate, NV-HHV-1 formulated as skin cream, for the treatment of Shingles. The Company plans on taking NV-HHV-1 into human clinical trials, and further develop the HerpeCide™ program after the Phase II clinical trial of NV-387 for RSV, MPox, and possibly for multiple other indications, including Influenzas. In the HerpeCide program alone, the Company has drug candidates against at least five indications at different stages of development. The Company’s drug candidates against HSV-1 “cold sores” and HSV-2 “genital herpes” are in advanced pre-clinical studies and are expected to follow the shingles drug candidate into human clinical trials. In addition, the Company has drug candidates against HIV/AIDS, Dengue, Ebola/Marburg, and other viruses.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">The Company’s drugs are based on several patents, patent applications, provisional patent applications, and other proprietary intellectual property held by TheraCour Pharma, Inc. (“TheraCour”), a related party substantially owned by Dr. Anil Diwan, to which the Company has broad, exclusive licenses. The licenses are to entire fields and not limited to specific compounds. In all, the Company has exclusive, worldwide licenses for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Herpes Simplex Virus (HSV-1 and HSV-2), Influenza and Asian Bird Flu Virus, Dengue viruses, Ebola/Marburg viruses, Japanese Encephalitis virus, viruses causing viral Conjunctivitis (a disease of the eye) and Ocular Herpes (restated), Varicella Zoster Virus (“VZV”) infections (i.e. Shingles and Chickenpox), and SARS-CoV-2 infections.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">Additionally, on September 23, 2024, the Company signed a Memorandum of Understanding (“MoU”) for all antivirals drug development with TheraCour whereby it has obtained a right of first refusal (ROFR) for all antiviral drug developments from TheraCour. This MoU expands the Company’s abilities to opportunistically and rapidly develop novel drugs to treat viral infections of public health importance, even for those viruses that don’t exist today and cannot be predicted. The MoU has also formalized the process of development of drugs for unlicensed viral indications leading later to appropriate license agreements. There was no compensation paid to or due to TheraCour as a result of this MoU. The Parties have also agreed in this MoU that any cash milestone payments related to development activities, that are awardable, will become payable only upon the Company having sufficient revenue, thus extending the provisions previously incorporated in the Amendment to the COVID License Agreement, to all present and future license agreements.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt 0pt 12pt 0pt;">In all cases, the discovery of ligands and polymer materials as well as formulations, the chemistry and chemical characterization, as well as process development and related work will be performed by TheraCour, a related party substantially owned by Dr. Anil Diwan, under the same compensation terms as prior agreements between the parties, with no duplication of costs allowed. Upon commercialization, NanoViricides will pay 15% of net sales to TheraCour. Milestone payments were made or are specified in certain of the license agreements, details of which have been disclosed at the time the agreements were entered into. The Company negotiates and licenses specific verticals of therapeutic applications from TheraCour if promising drug candidates are found in early research and development against a virus target. TheraCour has not denied any such licenses when requested.</p><p style="font-family:'Times New Roman','Times','serif';font-size:10pt;text-align:justify;margin:0pt;">The Company has out-licensed NV-CoV-2 and NV-CoV-2-R for further clinical drug development and commercialization in the territory of India to KMPL, a company of which Dr. Anil Diwan is a passive investor and advisor. KMPL has sponsored the NV-CoV-2 into Phase Ia/Ib human clinical trial, to study the safety and tolerability of the NV-CoV-2 Oral Syrup and NV-CoV-2 Oral Gummies formulations of the API NV-387 in healthy human subjects, described earlier. The clinical trial drug products, NV-CoV-2 Oral Syrup, and NV-CoV-2 Oral Gummies, were manufactured at the Company’s Shelton campus. Under the agreement with KMPL, the Company will pay for the expenses of the clinical trials, and in return will benefit from having the data and reports made available for regulatory filings in other territories of the world. Upon commercialization, the Company will receive royalties from KMPL equal to 70% of sales net of costs to unaffiliated third parties.</p>
CY2024Q3 us-gaap Number Of Reportable Segments
NumberOfReportableSegments
1
CY2024Q3 nnvc Percentage Of Royalties On Sales
PercentageOfRoyaltiesOnSales
0.70
CY2024Q3 us-gaap Retained Earnings Accumulated Deficit
RetainedEarningsAccumulatedDeficit
-142500000
CY2024Q3 us-gaap Net Income Loss
NetIncomeLoss
-3100000
CY2024Q3 us-gaap Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
-2600000
CY2024Q3 us-gaap Revenue From Contract With Customer Including Assessed Tax
RevenueFromContractWithCustomerIncludingAssessedTax
0
CY2024Q3 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
3900000
CY2024Q3 us-gaap Liabilities
Liabilities
1633000
CY2024Q3 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
283000
CY2024Q3 us-gaap Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
3900000
CY2024Q3 us-gaap Line Of Credit Facility Current Borrowing Capacity
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3000000
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InterestExpenseDebt
49808
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LeaseholdImprovementsGross
8168045
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LeaseholdImprovementsGross
8168045
CY2024Q3 us-gaap Land
Land
260000
CY2024Q2 us-gaap Land
Land
260000
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OfficeEquipmentGross
77425
CY2024Q2 nnvc Office Equipment Gross
OfficeEquipmentGross
63056
CY2024Q3 us-gaap Furniture And Fixtures Gross
FurnitureAndFixturesGross
5607
CY2024Q2 us-gaap Furniture And Fixtures Gross
FurnitureAndFixturesGross
5607
CY2024Q3 us-gaap Fixtures And Equipment Gross
FixturesAndEquipmentGross
6501973
CY2024Q2 us-gaap Fixtures And Equipment Gross
FixturesAndEquipmentGross
6469578
CY2024Q3 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
15013050
CY2024Q2 us-gaap Property Plant And Equipment Gross
PropertyPlantAndEquipmentGross
14966286
CY2024Q3 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
7647369
CY2024Q2 us-gaap Accumulated Depreciation Depletion And Amortization Property Plant And Equipment
AccumulatedDepreciationDepletionAndAmortizationPropertyPlantAndEquipment
7453823
CY2024Q3 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
7365681
CY2024Q2 us-gaap Property Plant And Equipment Net
PropertyPlantAndEquipmentNet
7512463
CY2024Q3 us-gaap Depreciation
Depreciation
193546
CY2023Q3 us-gaap Depreciation
Depreciation
187057
CY2024Q3 us-gaap Finite Lived Intangible Assets Gross
FiniteLivedIntangibleAssetsGross
458954
CY2024Q2 us-gaap Finite Lived Intangible Assets Gross
FiniteLivedIntangibleAssetsGross
458954
CY2024Q3 us-gaap Finite Lived Intangible Assets Accumulated Amortization
FiniteLivedIntangibleAssetsAccumulatedAmortization
135713
CY2024Q2 us-gaap Finite Lived Intangible Assets Accumulated Amortization
FiniteLivedIntangibleAssetsAccumulatedAmortization
133646
CY2024Q3 us-gaap Finite Lived Intangible Assets Net
FiniteLivedIntangibleAssetsNet
323241
CY2024Q2 us-gaap Finite Lived Intangible Assets Net
FiniteLivedIntangibleAssetsNet
325308
CY2024Q3 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
46857
CY2024Q2 us-gaap Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
23532
CY2024Q3 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
9000
CY2024Q2 us-gaap Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
11500
CY2024Q3 nnvc Accrued Clinical Trial Costs Current
AccruedClinicalTrialCostsCurrent
227435
CY2024Q2 nnvc Accrued Clinical Trial Costs Current
AccruedClinicalTrialCostsCurrent
227435
CY2024Q3 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
283292
CY2024Q2 us-gaap Accrued Liabilities Current
AccruedLiabilitiesCurrent
262467
CY2024Q3 ecd Non Rule10b51 Arr Adopted Flag
NonRule10b51ArrAdoptedFlag
false
CY2024Q3 ecd Non Rule10b51 Arr Trmntd Flag
NonRule10b51ArrTrmntdFlag
false
CY2024Q3 ecd Rule10b51 Arr Adopted Flag
Rule10b51ArrAdoptedFlag
false
CY2024Q3 ecd Rule10b51 Arr Trmntd Flag
Rule10b51ArrTrmntdFlag
false

Files In Submission

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0001410578-24-001991.txt Edgar Link pending
0001410578-24-001991-xbrl.zip Edgar Link pending
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