HSPGs

SHELTON, CT / ACCESSWIRE / February 15, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), reports that it has filed its Quarterly Report on Form 10-Q for the fiscal first quarter ending December 31, 2022 with the Securities and Exchange Commission (SEC) on Tuesday, February 14, 2023. The report can be accessed at the SEC website ( ). We reported that, as of December 31, 2022, we had cash and cash equivalent current assets balance of approximately $11.5 Million. In addition, we reported approximately $8.4 Million in Property and Equipment (P&E) assets, net of depreciation and amortization from $14.7 Million in P&E assets before depreciation. The strong P&E assets comprise our cGMP-capable manufacturing and R&D facility in Shelton, CT. The total current liabilities were approximately $0.46 Million. In comparison, as of September 30, 2022, we had cash and cash equivalent current assets balance of approximately $13.1 Million and total current liabilities were approximately $0.51 Million. The net cash utilized in the six months from July 1, 2022 was approximately $3.3 Million. The cash expenditure is expected to increase once clinical trials begin for NV-CoV-2, our lead drug candidate to treat SARS-CoV-2 infection that causes COVID-19. We estimate that we have sufficient funds to complete initial human clinical trials for our lead drug candidate NV-CoV-2 for the treatment of SARS-CoV-2 infection that causes the COVID-19 disease and also "long COVID." In the reported quarter, we have been compiling and performing medical writings needed for developing an IND application to the US FDA for human clinical trials of NV-CoV-2 in COVID-19 patients. We have also been compiling and performing medical writings that would be needed for international applications for clinical trials under the ICH and regulatory guidelines of certain countries. As a result, a clinical trial application for evaluation of oral administration of NV-CoV-2, as well as most of the associated agreements have been completed for one of our initiatives outside the USA. We expect to announce the resulting collaborations once the formal steps are completed. In addition, significantly, we have begun the manufacture of clinical supply of the drug substance NV-387. It is expected that our current 5Kg API manufacturing scale would be sufficient to treat approximately 1,000 patients, although the actual required dose for efficacy will only be established in clinical trials. We have developed three separate drug product formulations of NV-387 for the treatment of COVID-19 patients: (i) NV-CoV-2 Oral Gummies, a fixed-dose form for use in mild to moderate out-patient treatment; (ii) NV-CoV-2 Oral Syrup, the dosing quantity of which can be adjusted, as is needed in the case pediatric patients (based on body weight); and (iii) NV-CoV-2 Solution (Sterile) for Injection, Infusion, and Inhalation. In the reported quarter, we successfully designed and had externally fabricated custom filling, packaging, and sealing equipment for the oral syrup and oral gummies formulations at the clinical batch scale. We plan on having the NV-CoV-2 Injectable formulation made and packaged at an external contract manufacturer. Thus, NanoViricides is rapidly becoming one of very few small pharma companies that are fully "vertically integrated" ("vertically integrated" refers to having capabilities from drug discovery R&D to manufacturing and packaging of drug products in house). We believe that NV-CoV-2 addresses the unmet need for a safe and effective treatment that can be used in otherwise healthy patients as well as in children, based on its strong safety and effectiveness observed in animal studies. The currently available antivirals have limited applicability and effectiveness. Molnupiravir (Merck/Ridgeback) is severely restricted due to its mutagenicity and poor efficacy and unfavorable risk vs. benefit profile. Paxlovid (Pfizer) was found to be not effective in patients below 65 years of age and without co-morbidities. Remdesivir requires infusion and is limited to use in hospitalized patients with severe disease. NV-CoV-2 as oral syrup or oral gummies is expected to be useful for patients in all age ranges and patients with or without co-morbidities experiencing mild to moderate COVID-19. NV-CoV-2 Solution for Injection, Infusion, and Inhalation is designed to help severely ill hospitalized patients. We believe escape of new variants of SARS-CoV-2 from our drug NV-CoV-2 is highly unlikely. This is because we developed NV-CoV-2 as a broad-spectrum, pan-coronavirus drug that is active not only against SARS-CoV-2, but also against other unrelated coronaviruses. We believe this is exactly the kind of drug that is needed to combat the pandemic effectively and to be able to live with the virus, as a global society, as the SARS-CoV-2 virus is moving towards an endemic phase. We believe that NV-CoV-2 works by a novel mechanism of action; that of blocking the re-infection cycle of the viral disease. We believe that NV-CoV-2 not only binds to the virus, but fuses with the virus surface, uprooting the glycoproteins that are required for the virus to bind to the human cell (S protein, and its products S1 and S2 proteins), thereby rendering the virus incapable of infecting a cell. In contrast, antibodies are only capable of decorating the virus, generally incompletely. Previously, the Company has completed preclinical development of its lead drug candidate for the treatment of shingles rash, namely, NV-HHV-1. The Company intends to re-engage this program towards clinical trials for NV-HHV-1 regulatory approvals after our COVID-19 program. The nanoviricide platform technology is a leading nanomedicine technology that uniquely enables attack on both (a) the virus particles outside cells and (b) the replication of virus inside cells. If both of these factors can be controlled effectively, then the resulting drug could be a cure for the viral disease. In contrast, antibodies only bind to the virus particles outside cells, and tag them for the immune system for further processing, whereas antiviral small chemical drugs affect only the replication cycle of the virus inside cells. The virus-recognition ligand in NV-387 is designed to mimic certain features of heparan-sulfate proteoglycans (HSPG) and related glycosaminoglycans (GAG). HSPG serve as the initial attachment and concentration site for a large number of viruses, and also may serve as cellular entry sites for some viruses. Thus NV-387 is likely to have applicability in treating not just coronaviruses, but some other viral infections as well. We have begun the process of expanding the use spectrum of NV-387 which would greatly expand the return on investment (ROI). To this end, we have recently initiated two new programs in response to public health threats: (a) nanoviricides to treat Poxvirus infections (the Mpox epidemic previously known as MonkeyPox); and (b) nanoviricides to treat enteroviral infections. Enterovirus EV-D68, causes a pediatric disease called acute flaccid myelitis (AFM) that can lead to paralysis (AFP) in a small number of children. Poliovirus is also an enterovirus, and recently has been detected primarily in New York area. Our anti-viral therapeutics, that we refer to as "nanoviricides®" are designed to mimic and look to the virus like the native host cell surface to which it binds. We believe that our drug candidates would be difficult for a virus to escape because these binding sites for a given virus do not change despite mutations and other changes in the virus. Further, we believe that our drugs will be broad-spectrum, i.e. effective against most if not all strains, types, or subtypes, of a given virus, provided the virus- binding portion of the nanoviricide is engineered appropriately. The nanoviricide platform is designed to additionally hold small molecule active pharmaceutical ingredients (API's) of different types in its "belly". This allows targeted delivery of the encapsulated API to infected cells, and is also expected to improve the pharmacokinetic and pharmacodynamic properties of the API, such as rapid metabolism. Rapid metabolism is known to be an effectiveness-limiting factor for many drugs, including remdesivir. Remdesivir, developed by Gilead, is a drug that interferes with the replication of the SARS-Cov-2 virus and has been approved under emergency use regulations in the USA as well as in many other countries. 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. Our lead drug candidate is NV-CoV-2 for the treatment of COVID-19 disease caused by SARS-CoV-2 coronavirus. Our other advanced candidate is NV-HHV-1 for the treatment of Shingles (previously referred to as NV-HHV-101). 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 currently focused on advancing NV-CoV-2 into Phase I/II human clinical trials. NV-CoV-2 is our nanoviricide drug candidate for COVID-19 that does not encapsulate remdesivir. NV-CoV-2-R is our other drug candidate for COVID-19 that is made up of NV-CoV-2 with remdesivir encapsulated within its polymeric micelles. The Company believes that since remdesivir is already US FDA approved, our drug candidate encapsulating remdesivir is likely to be an approvable drug, if safety is comparable. Remdesivir is developed by Gilead. The Company has developed both of its own drug candidates NV-CoV-2 and NV-CoV-2-R independently. 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. 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". Contact: NanoViricides, Inc. info@nanoviricides.com Public Relations Contact: MJ Clyburn TraDigital IR clyburn@tradigitalir.com SOURCE: NanoViricides, Inc. View source version on accesswire.com:

Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the presentation of preclinical data for its first VDC product candidate, AU-011 which is being developed for the treatment of life-threatening cancers with high unmet need, including primary choroidal melanoma and non-muscle invasive bladder cancer. The results demonstrate the potential wide applicability of AU-011 in targeting a number of solid tumor types and will be presented as part of the 2022 American Association for Cancer Research (AACR) Annual Meeting, being held April 8-13, 2022 in New Orleans, LA. “The data that will be presented at AACR provide evidence for AU-011’s activity in tumors that express specifically modified heparan-sulfate proteoglycans on the tumor cell surface. Activity was observed in every tumor type tested, indicating that there are numerous solid tumors we can consider to expand the clinical development of AU-011, including those derived from neural or epithelial lineages,” said Dr. Cadmus Rich, Chief Medical Officer and Head of R&D of Aura Biosciences. “The correlative gene expression analysis has deepened our understanding of the genes and biological pathways involved in the expression of HSPGs by different types of tumor cells.”

Nov. 15, 2021 16:00 UTC Presentations Include Final Safety and Efficacy Data from the Phase 1b/2 Trial using Intravitreal Administration and Updated Safety Data from the Phase 2 Trial using Suprachoroidal Administration CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Aura Biosciences, Inc., a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the presentation of data evaluating its first VDC, AU-011, in indeterminate lesions (ILs) and choroidal melanoma (CM), including final safety and efficacy data from the Phase 1b/2 trial using intravitreal (IVT) administration, as well as updated safety results from the Phase 2 trial using suprachoroidal (SC) administration. The results are presented as part of the American Academy of Ophthalmology (AAO) 2021 Annual Meeting. “The final safety and efficacy data from the Phase 1b/2 trial using intravitreal administration presented today, along with the data from the Phase 2 trial using suprachoroidal administration, provide a high level of confidence for further clinical development in patients with indeterminate lesions or choroidal melanoma,” said Carol Shields, MD, Chief of the Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University. “I believe AU-011 may offer patients a safe, effective first-line therapy for early-stage disease that preserves vision, a critical component in patients’ quality of life often neglected with today’s current treatment options.” Final 12-Month Safety and Efficacy Data from Phase 1b/2 Trial with IVT administration The Phase 1b/2 trial (NCT03052127) evaluated the safety and efficacy of AU-011 using IVT administration for the treatment of ILs and CM. A total of 56 patients were enrolled in the Ph1b/2 trial including the single and multiple dose escalation cohorts and received up to two cycles of therapy (therapeutic regimen). As part of an enrichment strategy agreed with FDA, patients with small tumors with active growth were enrolled in the Phase 2 part of the study (expansion cohort). This group of patients (n=14) received the therapeutic regimen and were evaluated for the tumor growth rate, tumor control, and visual acuity preservation as the efficacy endpoints. These endpoints have been agreed with FDA and are planned to be used in the pivotal program. The results at 12 months showed a statistically significant reduction in the tumor growth rate (-0.483 mm/yr, p = 0.018) compared to each patient’s documented growth rate at study entry, and a 64% (9/14) tumor control rate. In addition, the visual acuity preservation rate was 71%, which is unprecedented compared to the current standard of care with radiotherapy. Overall, AU-011 demonstrated a favorable safety and tolerability profile. The majority of adverse events (AEs), which included intraocular inflammation and increased intraocular pressure, were transient and resolved without clinical sequelae. A large number of patients (43/56) had tumors close to the fovea and optic disk and only two patients with juxta-foveal tumors had a treatment related serious adverse event (SAE) of vision loss. No other treatment related SAEs were observed in the trial. These safety and efficacy results indicate that AU-011 may offer a targeted vision preserving therapy for the first line treatment of CM. Safety Data from Phase 2 Trial with SC Administration This Phase 2 trial (NCT04417530) includes an open-label, dose escalation phase assessing the safety and efficacy of AU-011 via SC administration in patients with ILs and CM and plans to enroll up to 22 patients. In this preliminary safety data review of the initial dose escalation cohorts (n=14), no treatment related SAEs, dose limiting toxicities (DLTs), or grade 3/4 AEs were reported. Preliminary results indicate a positive safety and tolerability pro AU-011 via SC administration. Details for the AAO 2021 Presentations are as follows: Title: A Phase 1b/2 Trial of AU-011, a First in Class Targeted Therapy for the Treatment of Choroidal Melanoma via Intravitreal Administration Presenter: Carol L. Shields, Wills Eye Hospital Session: OP10 Ocular Pathology and Oculoplastics Original Paper Session Date and time: Monday, November 15 from 9:45 – 9:52 AM CT Location: 255-257 Title: A Phase 2 Trial of a First in Class Targeted Therapy for Choroidal Melanoma via Suprachoroidal (SC) Administration Presenter: Hakan Demirci, Kellogg Eye Center Session: PD08 Ocular Pathology and Oculoplastics Poster Discussion Date and time: Available on demand beginning Friday, November 12, 2021, at 7:30am PT Location: Virtually on demand The presentations can be accessed by visiting the “Scientific Presentations” section of “VDC Platform” page of the Aura Biosciences website. About Choroidal Melanoma Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts, and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal. There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the mortality rate in metastatic disease, lack of approved therapies, and the comorbidities of radioactive treatment options. About AU-011 AU-011 is a first-in-class virus-like drug conjugate (VDC) therapy in clinical development for the first line treatment of choroidal melanoma. The virus-like component of the VDC selectively binds unique heparin sulphate proteoglycans (HSPGs), which are modified and overexpressed on the tumor cell surface of malignant cells in the choroid and AU-011 delivers a potent cytotoxic drug that is activated with infrared light. Upon activation with an ophthalmic laser, the cytotoxic drug rapidly and specifically disrupts the cell membrane of malignant cells with a pro-immunogenic cell death that can activate the immune system generating long term anti-tumor immunity. The unique specificity of tumor binding by the VDC enables the preservation of key eye structures, which may allow for the potential of preserving patients’ vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist’s office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma is currently in Phase 2 clinical development and the company plans to expand the clinical program into choroidal metastasis. About Suprachoroidal Administration The suprachoroidal space (SCS®) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Aura believes that delivering AU-011 into SCS within the eye, has the potential to offer certain advantages, including higher bioavailability at the tumor site and reduced exposure of non-targeted tissues, which may lead to an improved therapeutic index for AU-011. Collectively, these features could allow for the treatment of a wider range of tumor sizes, and, therefore, a larger number of patients may be treatable. The Company is partnered with Clearside Biomedical for use of Clearside’s SCS Microinjector® for administration of AU-011 into the SCS. About Aura Biosciences Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute. The company has the goal of developing this technology in multiple cancer indications with an initial focus on primary choroidal melanoma, a rare disease for which there are no approved drugs. Aura’s lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of primary choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. AU-011 was well tolerated in a Phase 1b/2 trial, demonstrating high rates of tumor control and vision preservation. Future pipeline applications for Aura’s technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA. Forward Looking Statement This press release may contain forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding Aura’s future expectations, plans and prospects, including, without limitation, statements regarding expectations and plans for presenting clinical data, projections regarding our long-term growth, the anticipated timing of our clinical trials and regulatory filings, the development of our product candidates and advancement of our clinical programs, as well as other statements containing words such as “may,” “will,” “could”, “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions that can be used to identify forward-looking statements. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; whether interim results from a clinical trial, including the Phase 2 SC administration trial, will be predictive of the final results of the trial; whether results from pre-clinical studies or earlier clinical studies will be predictive of the results of future trials, including regarding AU-011’s ability to offer vision preserving therapy for the first line treatment of choroidal melanoma; the expected timing of the expansion phase of the Phase 2 SC administration trial; the expected timing for submissions for regulatory approval or review by governmental authorities; whether Aura will receive regulatory approvals to conduct trials or to market products; whether Aura’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on Aura’s business, operations, strategy, goals and anticipated timelines, Aura’s ongoing and planned pre-clinical activities, Aura’s ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, Aura’s timelines for regulatory submissions and Aura’s financial position. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” set forth in Aura’s filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although Aura believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither Aura nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. Aura undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.