Tecovirimat

Novel Host-Mimetic, Virus Killing Technology Platform SHELTON, CT / ACCESSWIRE / May 29, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a clinical-stage global leader in broad-spectrum antiviral nanomedicines, elaborates on its development of a first-in-class, broad-spectrum antiviral agent that could revolutionize treatment of viral infections including RSV, COVID, Influenzas and other viruses. "Resistance is Futile" - Host-Mimetic Technology To Solve the Greatest Pain for Antiviral Medicines, i.e. Virus Escape No matter how much a virus changes in the field, it uses the same "landing sites" in the host body to gain access to cells, attach to and then fuse into the cells, causing an infection. A drug using the same landing sites and acting as a "decoy" would remain effective against the virus even as the virus changes, because the host side does not change. NV-387 is designed to employ such advanced "host-mimetic" technology, built into the nanoviricide™ nanomedicine that is further designed to "look like a cell" to the virus. In contrast, vaccines, antibodies and small chemical drugs all lose their effectiveness as the virus changes in the field. The virus is constantly changing due to various natural mechanisms such as mutations, recombinations, and/or re-assortments that are native to the virus lifecycle. Extremely Broad Antiviral Spectrum of NV-387 Resulted Because Many Diverse Viruses Use Common Host-Side Landing Sites Over 90% of human pathogenic viruses are known to use one or more "landing sites" that are in the Sulfated Proteoglycans ("SPG") family. A successful host-mimetic nanoviricide drug using SPG as the key feature to attract viruses could theoretically be able to attack most if not all such viruses. NV-387 is designed to mimic SPG and attack the virus as a cell-mimicking decoy. We have accumulated substantial evidence that in lethal viral infection animal studies, NV-387 demonstrated strong antiviral activity against a range of different virus families, exceeding or matching the activity of known approved drug agents. NV-387 was substantially superior to remdesivir in coronavirus infections, using a model for SARS-CoV-2 (COVID) virus, as reported earlier. We believe that NV-387 continues to be one of the most active antiviral drugs against multiple coronaviruses, and that it is a viable clinical candidate for drug development to treat COVID, Long COVID, as well as potentially MERS, SARS, and seasonal coronavirus infections. NV-387 was substantially superior to the three approved drugs, namely Tamiflu®, Rapivab® , and Xofluza® against an Influenza H3N2 lethal lung viral infection study, as previously reported. We believe that NV-387 is expected to possess strong antiviral activity against H5N1 "Bird Flu" as well, given that H5N1 viruses are known to bind to heparan sulfate proteoglycans, and based on the observed broad-spectrum activity of NV-387. NV-387 was at least as good as TPOXX® in a model animal study for the development of Smallpox/Mpox drugs, in two different ways of acquiring infection, as reported earlier. Further, we found that NV-387 is capable of completely curing a lethal RSV lung virus infection in animals, leading to indefinite survival of the animals, as reported recently. There is no cure for RSV, and no approved drug for treatment of RSV infection other than the toxic last-resort drug ribavirin. Moreover, even novel viruses, whether from natural sources or bio-engineered, are expected to be susceptible to NV-387 if they employ SPG for gaining access to human cells to infect and cause disease. Thus, NV-387 could be highly valuable for preparedness against novel viral epidemics and pandemics. NV-387 could thus be a single drug to treat all of the "tripledemic" viruses, and more, when so approved. Safety of NV-387 Studied Successfully in Phase I Human Clinical Trials with No Adverse Events NV-387 is inherently designed to be safe, by careful choice of the components of the nanoviricide polymeric chemical, and this was borne out in our studies. Leading to the human clinical trials, we had found that the safety of NV-387 was demonstrated by the very large NOAEL value of 1,200mg/Kg and MTD value of 1,500mg/Kg in rats. We had also found that NV-387 was non-mutagenic, non-genotoxic, non-immunogenic, and studies indicated that allergenicity was not an issue; all parameters that indicate excellent safety. A Phase I clinical trial of NV-387 Oral Syrup and NV-387 Oral Gummies was completed successfully with no adverse events reported. We are awaiting reports from the CRO to further elaborate on the findings. "An antiviral agent with an extra-ordinarily broad spectrum of antiviral activity, coupled with strong safety, is a ‘holy grail' of antiviral medicines," said Anil R. Diwan, Ph.D., President and Executive Chairman of the Company, adding, "Our host-mimetic, direct-acting, nanoviricide™ platform technology capable of destroying virus particles has made this possible, we believe. NV-387 is now ready for Phase II studies towards the goal of regulatory approvals worldwide." He further commented, "If and when approved, NV-387 could be as revolutionary an antiviral agent as penicillin was as an anti-bacterial agent." About NanoViricides NanoViricides, Inc. (the "Company") ( ) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Additionally, nanoviricides mimick the host-side features that the viruses continue to require in spite of mutations, and therefore the viruses would be highly unlikely to escape the nanvoricide drugs. Our lead drug candidate is NV-387 (drug product NV-CoV-2) for the treatment of RSV, COVID-19, Long COVID, Influenza, Bird Flu H5N1, and other respiratory viral infections. NV-387 has successfully completed a Phase 1a/1b human clinical trial in healthy subjects with no reported adverse events even at the highest and repeated dosages. This trial was conducted by the drug sponsor, Karveer Meditech Pvt. Ltd., our licensee and collaborator in India. The Company is currently focused on advancing NV-387 into Phase II human clinical trials for treatment of RSV infection. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles rash, HSV-1 "cold sores" and HSV-2 "genital ulcers". The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides' platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for poxviruses and/or enteroviruses if the initial research is successful. The Company's technology is based on broad, exclusive, sub-licensable, field licenses to drugs developed in these areas from TheraCour Pharma, Inc. The Company's business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company's pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product. This press release contains forward-looking statements that reflect the Company's current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company's control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company's expectations include, but are not limited to, those factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products. The phrases "safety", "effectiveness" and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA. "NOAEL" means "No-Observed-Adevrese-Event-Level", which is the maximum dosage employed at which there were no adverse events found in animal studies. "MTD" means "Maximum Tolerated Dose", which is the maximum dosage employed that does not compromise survival of the animals. FDA refers to US Food and Drug Administration. IND application refers to "Investigational New Drug" application. cGMP refers to current Good Manufacturing Practices. CMC refers to "Chemistry, Manufacture, and Controls". CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency's (EMA) committee responsible for human medicines. API stands for "Active Pharmaceutical Ingredient". API means active pharmaceutical ingredient. Contact: NanoViricides, Inc. info@nanoviricides.com Public Relations Contact: MJ Clyburn, TraDigital IR clyburn@tradigitalir.com SOURCE: NanoViricides, Inc. View the original press release on accesswire.com

Generated Product Sales of $24 Million and Pre-tax Operating Income of $11 MillionCorporate Update Conference Call Today at 4:30 PM ET NEW YORK, May 07, 2024 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company, today reported financial results for the three months ended March 31, 2024. “SIGA delivered strong results in the first quarter, with product revenues of $24 million and pre-tax operating income of $11 million, both up over the comparable quarter in 2023,” said Diem Nguyen, Chief Executive Officer. “First quarter financial performance is a testament to our focus on financial and operational excellence, the value of our TPOXX® franchise, and the resilience of our team. We remain committed to advancing our strategy and enhancing shareholder value as we look forward to progressing our clinical programs, negotiating the next contract with the U.S. Government, and promoting public health.” Summary Financial Results ($ in millions, except per share amounts)Three Months Ended March 31 20242023 Product sales(1)$23.9$5.7 Total revenues$25.4$8.3 Operating income (loss)(2)$11.3($2.1)Income (loss) before income taxes(2)$13.2($1.2)Net income (loss)$10.3($0.9)Diluted income (loss) per share$0.14($0.01) (1)Includes supportive services related to product sales.(2)Operating income (loss) excludes, and income (loss) before income taxes includes, other income. Both line items exclude the impact of income taxes. Recent Developments: On April 11, 2024, the Company’s partner in Japan, Japan Biotechno Pharma, announced that a new drug application for tecovirimat (TPOXX) was filed in Japan for the treatment of smallpox, mpox, cowpox, and complications due to vaccinia virus. On April 1, 2024, the Company announced that it entered into an amendment of its international promotion agreement with Meridian Medical Technologies, LLC (Meridian). Effective June 1, 2024, SIGA will drive international promotion activities for oral TPOXX® while maintaining its contractual relationship with Meridian to maintain continuity for key customer relationships. With the amendment, SIGA will have greater control over international promotion activities, which will enable the Company to meet global customers’ needs more effectively during these uncertain times of orthopox threats. In first-quarter 2024, SIGA delivered approximately $24 million of oral TPOXX to a diverse mix of customers. Approximately $16 million of oral TPOXX was delivered to the U.S. government, including $15 million of deliveries to the U.S. Strategic National Stockpile and a $1 million delivery to the U.S. Department of Defense, and approximately $8 million of oral TPOXX was delivered to eight international customers. Capital Management Activity: On March 12, 2024, SIGA’s Board of Directors declared a special cash dividend of $0.60 per share, which was paid on April 11, 2024. Conference Call and Webcast SIGA will host a conference call and webcast to provide a business update today, Tuesday, May 7, 2024, at 4:30 P.M. ET. Participants may access the call by dialing 1-888-886-7786 for domestic callers or 1-416-764-8658 for international callers. A live webcast of the call will also be available on the Company's website at www.siga.com under the 'Events & Presentations' tab in the Investor Relations section, or by clicking here. Please log in approximately 5-10 minutes prior to the scheduled start time. A replay of the call will be available for two weeks by dialing 1-844-512-2921 for domestic callers or 1-412-317-6671 for international callers and using Conference ID: 27772151. The archived webcast will be available in the Events and Presentations section of the Company's website. ABOUT SIGA TECHNOLOGIES, INC. SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is TPOXX®, also known as tecovirimat and ST-246, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. ABOUT TPOXX® TPOXX is a novel small-molecule drug and the U.S. maintains a supply of TPOXX under Project BioShield. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018, and the IV formulation was approved for the same indication in 2022. The full label is available by clicking here. Oral tecovirimat received approval from the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom in 2022. The EMA and UK approvals include labeling for oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox. The full label is available by clicking here. In September 2018, SIGA signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, for additional procurement and development related to both oral and intravenous formulations of TPOXX. For more information about SIGA, please visit www.siga.com. ABOUT ORTHOPOXVIRUSES Orthopoxvirus, belonging to the family of poxvirus that infect humans, include smallpox, mpox, cowpox and vaccinia. Smallpox, a highly contagious and fatal disease, presents itself as a risk to global health security today given fears of its release accidentally or intentionally as a bioweapon. Mpox virus, similar to smallpox, causes intermittent human infections, painful lesions, and possible case fatalities. Mpox outbreaks have been observed recently in the US, Europe, and Central & West Africa. Whether through natural occurrence or potential bioweapon warfare, orthopox threatens global health. Anti-virals and vaccines serve as possible solutions to address these threats. FORWARD-LOOKING STATEMENTS This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements relating to SIGA’s future business development and plans including securing new contracts and partnerships. The words or phrases “can be,” “expects,” “may affect,” “may depend,” “believes,” “estimate,” “will”, “project” and similar words and phrases are intended to identify such forward-looking statements. Such forward-looking statements are subject to various known and unknown risks and uncertainties, and SIGA cautions you that any forward-looking information provided by or on behalf of SIGA is not a guarantee of future performance. SIGA’s actual results could differ materially from those anticipated by such forward-looking statements due to a number of factors, some of which are beyond SIGA’s control, including, but not limited to, (i) the risk that BARDA elects, in its sole discretion as permitted under the 19C BARDA Contract (the “BARDA Contract”), not to exercise all, or any, of the remaining unexercised options under those contracts, (ii) the risk that SIGA may not complete performance under the BARDA Contract on schedule or in accordance with contractual terms, (iii) the risk that the BARDA Contract or U.S. Department of Defense contracts are modified or canceled at the request or requirement of, or SIGA is not able to enter into a new contract to supply TPOXX to, the U.S. Government, (iv) the risk that the nascent international biodefense market does not develop to a degree that allows SIGA to continue to successfully market TPOXX internationally, (v) the risk that potential products, including potential alternative uses or formulations of TPOXX that appear promising to SIGA or its collaborators, cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical trials, (vi) the risk that target timing for deliveries of product to customers, and the recognition of related revenues, are delayed or adversely impacted by the actions, or inaction, of contract manufacturing organizations, or other vendors, within the supply chain, or due to coordination activities between the customer and supply chain vendors, (vii) the risk that SIGA or its collaborators will not obtain appropriate or necessary governmental approvals to market these or other potential products or uses, (viii) the risk that SIGA may not be able to secure or enforce sufficient legal rights in its products, including intellectual property protection, (ix) the risk that any challenge to SIGA’s patent and other property rights, if adversely determined, could affect SIGA’s business and, even if determined favorably, could be costly, (x) the risk that regulatory requirements applicable to SIGA’s products may result in the need for further or additional testing or documentation that will delay or prevent SIGA from seeking or obtaining needed approvals to market these products, (xi) the risk that the volatile and competitive nature of the biotechnology industry may hamper SIGA’s efforts to develop or market its products, (xii) the risk that changes in domestic or foreign economic and market conditions may affect SIGA’s ability to advance its research or may affect its products adversely, (xiii) the effect of federal, state, and foreign regulation, including drug regulation and international trade regulation, on SIGA’s businesses, (xiv) the risk of disruptions to SIGA’s supply chain for the manufacture of TPOXX®, causing delays in SIGA’s research and development activities, causing delays or the re-allocation of funding in connection with SIGA’s government contracts, or diverting the attention of government staff overseeing SIGA’s government contracts, (xv) risks associated with actions or uncertainties surrounding the debt ceiling, (xvi) the risk that the U.S. or foreign governments' responses (including inaction) to national or global economic conditions or infectious diseases, are ineffective and may adversely affect SIGA’s business, and (xvii) risks associated with responding to an mpox outbreak, as well as the risks and uncertainties included in Item 1A “Risk Factors” of our Annual Report on Form 10-K for the year ended December 31, 2023 and SIGA's subsequent filings with the Securities and Exchange Commission. SIGA urges investors and security holders to read those documents free of charge at the SEC's website at http://www.sec.gov. All such forward-looking statements are current only as of the date on which such statements were made. SIGA does not undertake any obligation to update publicly any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events. Contacts: InvestorsMediaJennifer Drew-Bear, Edison Groupjdrew-bear@edisongroup.comHolly Stevens, Berry & Companyhstevens@berrypr.com SIGA TECHNOLOGIES, INC.CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)As of March 31, 2024 December31, 2023 ASSETS Current assets Cash and cash equivalents$143,868,648 $150,145,844 Accounts receivable 18,127,180 21,130,951 Inventory 63,721,788 64,218,337 Prepaid expenses and other current assets 2,174,993 3,496,028 Total current assets 227,892,609 238,991,160 Property, plant and equipment, net 1,193,237 1,331,708 Deferred tax asset, net 11,011,668 11,048,118 Goodwill 898,334 898,334 Other assets 2,149,482 2,083,535 Total assets$243,145,330 $254,352,855 LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities Accounts payable$2,523,350 $1,456,316 Accrued expenses and other current liabilities 6,122,929 10,181,810 Dividend payable 42,673,509 — Deferred IV TPOXX® revenue 20,788,720 20,788,720 Income tax payable 2,703,690 21,690,899 Total current liabilities 74,812,198 54,117,745 Other liabilities 3,342,927 3,376,203 Total liabilities 78,155,125 57,493,948 Commitments and contingencies Stockholders’ equity Common stock ($.0001 par value, 600,000,000 shares authorized, 71,122,516 and 71,091,616, issued and outstanding at March 31, 2024 and December 31, 2023, respectively) 7,112 7,109 Additional paid-in capital 236,766,447 235,795,420 Accumulated deficit (71,783,354) (38,943,622)Total stockholders’ equity 164,990,205 196,858,907 Total liabilities and stockholders’ equity$243,145,330 $254,352,855 SIGA TECHNOLOGIES, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME/(LOSS) (UNAUDITED) Three Months Ended March 31, 2024 2023 Revenues Product sales and supportive services$23,878,677 $5,702,515 Research and development 1,551,178 2,620,510 Total revenues 25,429,855 8,323,025 Operating expenses Cost of sales and supportive services 3,225,314 1,150,187 Selling, general and administrative 7,875,773 4,235,108 Research and development 3,053,369 5,046,036 Total operating expenses 14,154,456 10,431,331 Operating income/(loss) 11,275,399 (2,108,306)Other income, net 1,942,437 890,629 Income/(loss) before income taxes 13,217,836 (1,217,677)(Provision)/benefit for income taxes (2,940,496) 299,422 Net and comprehensive income/(loss)$10,277,340 $(918,255)Basic income/(loss) per share$0.14 $(0.01)Diluted income/(loss) per share$0.14 $(0.01)Weighted average shares outstanding: basic 71,093,653 72,197,038 Weighted average shares outstanding: diluted 71,562,996 72,197,038