NanoViricides Quarterly Report

 NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a global leader in broad-spectrum antiviral nanomedicines, reports that it has filed its Quarterly Report on Form 10-Q for the fiscal second quarter ending March 31, 2024 with the Securities and Exchange Commission (SEC) on Tuesday, May 14, 2024. The report can be accessed at the SEC website by searching for the Company's filings.

Financial Status

We reported that, as of March 31, 2024, we had cash and cash equivalent current assets balance of approximately $3.51 Million. Additional agreements have resulted in a further approximately $2.5 Million available cash, that would be equivalent to a total of approximately $6 Million cash available to the Company with no further costs.

In addition, we reported approximately $7.92 Million in Property and Equipment (P&E) and Intangible assets, net of depreciation and amortization from $14.7 Million in P&E assets before depreciation. The strong P&E assets are comprised of our cGMP-capable manufacturing and R&D facility in Shelton, CT. The total current liabilities were approximately $0.81 Million. In comparison, as of June 30, 2023, we had cash and cash equivalent current assets balance of approximately $8.15 Million, and additional approximately $8.1 Million in Property and Equipment (P&E) assets, net of depreciation and amortization, while the total current liabilities were approximately $0.41 Million. The net cash utilized in the nine months from July 1, 2023 was approximately $4.84 Million.

We anticipate certain additional costs from the Phase 1 clinical trial in India, which was completed recently, from the continuing work on statistical evaluations, and generation and submission of the Phase 1 final report.

Management believes that the Company's existing resources, including availability under its $2 million line of credit will not be sufficient to fund the Company's planned operations and expenditures for at least 12 months from the date of the filing of this Form 10-Q. As a result substantial doubt exists about the Company's ability to continue as a going concern.

Management plans to continue controlling its overall expenses and identifying and securing additional financing, as it has done in the past.

We are seeking to mortgage our headquarters facility, estimated to be worth over $12-15 million, with a replacement cost exceeding $25 Million, in order to free up liquidity. There is currently no mortgage on this facility and it is fully owned by NanoViricides, Inc. To date, we have raised funds in the equity markets for the development of our assets.

Additionally, we now have a clinical asset in NV-387 that is available for partnering. If partnered successfully, we can anticipate substantial initial payment, and milestone and royalty payments.

NV-387, A Unique Drug Candidate with Broad-Spectrum Antiviral Activity Poised to Transform the Treatment of Viral Infections Reminiscent of the Broad-Spectrum Antibacterial Activity of Penicillin that Transformed Treatment of Bacterial Infections

While NV-387 was developed in the context of the COVID-19 pandemic as a broad-spectrum pan-Coronavirus drug, we have found that it has strong antiviral activity against diverse types and families of viruses that include Coronaviruses, RSV, Influenza A, as well as Smallpox/Mpox in relevant animal models of these infections.

Thus NV-387 could be the single drug that can combat all of the "tripledemic" viruses - Coronaviruses, RSV, and Influenza, an unmet medical need.

We have found that the antiviral activity of NV-387 against RSV is strong enough to enable lethally infected animals to survive completely and not succumb to the infection. NV-387 thus could possibly be able to cure RSV infection.

Therefore, having completed the Phase I successfully, we plan on advancing NV-387 towards Phase II clinical trial for the treatment of RSV infection under the US FDA. Our goal is to obtain regulatory approval for the use of NV-387 for the treatment of RSV infection in infants and children, where there is a critical unmet need. There is no drug approved for RSV treatment, except the last resort toxic drug ribavirin.

Additionally, we plan on advancing NV-387 into Phase II studies for antiviral indications in India as well. We are in discussions with subject matter experts to determine how to harness the extremely broad-spectrum antiviral activity of NV-387 for rapid approval for the treatment of severe acute respiratory infections caused by viruses.

Update on Further Development of NV-387 (NV-CoV-2) for COVID Indication

The Phase 1 clinical trial for our lead drug candidate NV-CoV-2 (API NV-387) has completed successfully with no adverse events reported and clinical sites were closed in India. The COVID patient treatment part of the clinical trial could not be completed due to lack of patients eligible for recruitment as there were no COVID patients when our licensee and collaborator, Karveer Meditech Pvt Ltd and the CRO, PristynCR opened a second site in Salem, TamilNadu where a mini-COVID wave happened during February, 2024. However, by the time the second site was fully authorized with all regulatory approvals, the COVID wave had already passed and no COVID patients were found in a whole week of testing. Therefore, the CRO, the drug sponsor KMPL, in consultation with Principal Investigator, took the decision to close the clinical trial, having completed the Phase 1 clinical trial for the evaluation of safety and tolerability of NV-387 in healthy subjects in Single Ascending Dose and Multiple Ascending Dose studies, with no adverse events reported.

The work on this clinical trial will continue and a final Phase 1 Clinical Trial Report will be generated and submitted.

The weakening of the pandemic has worsened the difficulties in conducting clinical trials for COVID indication. We will continue to find non-dilutive funding for both COVID and Long COVID treatment, because we believe NV-387 has substantial chances of providing patient benefits in these cases. We plan on focusing our meager resources towards further development of NV-387 for the treatment of RSV, which is an endemic infection.

NanoViricides Drug Pipeline Addresses Several Billion Dollars in Market Sizes for Many Unmet Medical Needs

The market size for COVID drugs is expected to continue to be in the billions of dollars range while drug development for this indication has become challenging.

The market size of an RSV therapeutic is estimated to be several billions of dollars.

Although smallpox therapeutics are limited to government stockpiling, the market size for an effective smallpox therapeutic is estimated to be in the order of several hundred million dollars per year.

In addition the Company has previously developed the drug candidate NV-HHV-1 through IND-enabling safety/toxicology studies. NV-HHV-1 skin cream formulation is designed for the treatment of Shingles Rash, and is also effective against HSV-1 "cold sores" and HSV-2 "genital ulcers". Additionally the Company has a deep and wide pipeline of drug candidates with successful pre-clinical antiviral activity found against a large number of viruses including HIV, Influenza, and others.

Escape of Viruses from NanoViricides Platform Drugs is Unlikely

NanoViricides Platform Technology has an important advantage in that no matter how much a virus changes in the field, it is unlikely to escape the nanoviricide drug because it is designed to mimic the very host-side features that the virus uses to bind to and enter cells. These specific molecular signature features on the cellular side do not change even as the virus mutates, and nanoviricides are designed to mimic these features. In contrast, viruses readily escape antibodies as drugs, as well as vaccine-induced immunity as they evolve in the field, as is well known from the COVID-19 pandemic as well as Influenza pandemics and the continuing HIV/AIDS pandemic.

Specifically, NV-387 is designed to mimic the host-side feature of Sulfated-Proteoglycans (S-PG) that is used by over 90% of human pathogenic viruses. This, we believe, is the key to its unprecedented, ultra-broad-spectrum antiviral activity crossing virus family and type boundaries.

A safe and effective antiviral drug that the virus would not escape by simple mutations or field evolution is the holy grail of antiviral drug development. We believe that the NanoViricides Platform technology meets this challenge.

Additional information regarding the NanoViricides Platform Technology, and the NanoViricides Drug Pipeline can be found in our Annual Report filed with the SEC filed with the SEC on October 13, 2023.

https://www.accesswire.com/863489/nanoviricides-has-filed-its-quarterly-report

Cabaletta results, update

 – No CRS or ICANS of any grade observed during the 28-day DLT observation window for either of the first patients dosed with CABA-201 in the RESET-Myositis™ and RESET-SLE™ trials –

– Initial clinical data from each of the first patients in the RESET-Myositis and RESET-SLE trials to be presented at a satellite symposium at the EULAR 2024 Congress in June –

– Evaluating CABA-201 without preconditioning by initiation of the RESET-PV™ sub-study within the ongoing DesCAARTes™ trial in pemphigus vulgaris –

https://www.biospace.com/article/releases/cabaletta-bio-reports-first-quarter-2024-financial-results-and-provides-business-update/

iCAD Reports Financial Results for First Quarter

 iCAD, Inc. (NASDAQ: ICAD) a global leader on a mission to create a world where cancer can’t hide by providing clinically proven AI-powered breast health solutions, today reported its financial and operating results for the three months ended March 31, 2024.

First Quarter 2024 Highlights (Year over Year Performance):

• Total ARR was $9.0 million, up 10%
• Total revenues were $5.0 million, up 14%
• Gross Profit Margin % was 83%, up from 82%
• GAAP Net Loss from continuing operations ($1.2) million, improvement from ($3.1) million
• Operating cash flow was ($1.2) million, improvement from ($1.5) million

“Over the past year, we have demonstrated strong execution of our three-phased transformation plan that has positioned iCAD for growth and created a platform to drive additional shareholder value,” said Dana Brown, President and CEO of iCAD, Inc. “Phases 1 and 2 of our transformation plan focused on realigning the company’s base and strengthening its foundation. These efforts stabilized cash burn, fortified leadership, increased cash on hand and repositioned iCAD for growth in 2024 and beyond. Phase 3, “Investing in Growth,” commenced this quarter with a focus on expanding into key accounts and new markets. We are seeing the early signs of success from our key growth initiatives that included targeted lead generation programs, a revamped commercial model, strategic additions to the sales team, and new enhancements to our ProFound Breast Health Suite including release of ProFound Cloud.”

Conference Call:
A conference call will be held today, Wednesday, May 15, 2024 at 8:30 AM ET.
Domestic:		877-545-0523
International:		973-528-0016
Access Code:		730845
Webcast:		https://www.webcaster4.com/Webcast/Page/2879/50453 https://www.biospace.com/article/releases/icad-reports-financial-results-for-first-quarter-ended-march-31-2024/

White House 'Deeply Troubled' As Georgia Enacts Law To Thwart NGO 'Interference'

 Defying large domestic protests and condemnation from the United States and other Western governments, the Republic of Georgia's parliament on Tuesday adopted a "foreign agents" law that would impede foreign nongovernmental organizations' (NGOs') ability to operate in the country -- and put Georgia's European Union and NATO ambitions in jeopardy. 

Georgia's president, Salome Zourabichvili, has vowed to veto the measure, but the parliament approved the law by a 84-30 margin, only only needs 76 to override a veto. After the law's passage, Biden Press Secretary Karine Jean-Pierre told reporters: 

"We’re deeply troubled by Georgia’s Kremlin-style 'foreign agents' legislation...we have been outspoken about our concerns with the legislation, which runs counter to democratic values and would move Georgia further away from the values of the European Union and, let’s not forget, also NATO."

Under the Georgia law, which is modeled after one adopted in Russia, organizations that receive more than 20% of their funding from outside the country would have to register as "agents of foreign influence," under threat of fines. While Western governments officially scoff at the notion, NGOs have been a major vector of Western interference in foreign countries, up to and including regime change campaigns. NGOs played roles of varying significance in the so-called "Colour revolutions" in Georgia, Ukraine and Kyrgyzstan.  

Ironically reinforcing the idea that the law would thwart foreign interference, the German Foreign Affairs Committee chairman Michael Roth and Lithuanian legislator Zhigimantas Pavillionis visited the protest rally outside the parliament -- conjuring images of late US Senator John McCain and Sen. Chris Murphy joining anti-government protesters in Kiev as the Ukraine revolution gained momentum.  

In a vivid display of the intensity of feelings over the law, fists flew in parliament earlier this year: 

In recent months, Georgia has seen large protests against the law, with university students playing a major role. On Monday, 30 different colleges in the country saw students declare "strikes" and join demonstrations that decry "the Russian law."  

According to some polls, upwards of 89% of Georgians support EU membership to some degree -- but, ironically, most of these polls seem to be organized by NGOs like the National Democratic Institute and International Republican Institute. Demonstrators frequently wave EU flags and on Tuesday played the EU anthem... 

The protests have periodically erupted in violence, with police resorting to tear gas, water canons and clubs. 

European Commission spokesman Peter Stano echoed the White House's warning about the law's effect on Georgia's potential EU membership, telling the Financial Times:

“[The law is] very dangerous for Georgia’s European ambitions. The expectations are very clear — if this piece of legislation is adopted, it will be a grave obstacle for Georgia when it comes to [its] European outlook.”

The parliament's ruling coalition is led by the Georgian Dream party. On Tuesday, the party's principal benefactor, Bidzina Ivanishvili, refused to meet with German and US officials who wanted to persuade him to intervene and prevent the vote from taking place. 

What's next? The parliament has 10 days to deliver the bill to Georgian President Zourabichvili. She then has two weeks to issue her promised veto, and then an override seems a certainty. Then things will get interesting as foreign-funded NGOs will have to start complying with the registration requirement or cease their activities. Don't expect the US empire to sit on its hands...

https://www.zerohedge.com/geopolitical/white-house-deeply-troubled-georgia-enacts-law-thwart-ngo-interference

Eisai initiates rolling Biologics License Application to US FDA for Leqembi

  BioArctic AB's (publ) (NASDAQ STOCKHOLM: BIOA B) partner Eisai announced today that they have initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: Leqembi) subcutaneous autoinjector for weekly maintenance dosing after it was granted Fast Track designation by the FDA. In the US, Leqembi is indicated for the treatment of Alzheimer's disease (AD) in patients with Mild Cognitive Impairment (MCI) or mild dementia stage of disease (collectively referred to as early AD).

Leqembi is approved for biweekly intravenous (IV) treatment, which is normally done at medical facilities. Subcutaneous administration with an autoinjector simplifies home treatment and the injection process requires less time than the IV formulation. This makes the treatment easier for patients and their care partners and may reduce the need for hospital visits and nursing care compared to IV administration, in addition to being more convenient for patients to continue the treatment.

Alzheimer's disease is an ongoing neurotoxic process that begins before and continues after amyloid-beta (Aβ) plaque deposition, which is a hallmark of the disease. Data suggests that early and continued treatment may prolong the benefit even after Aβ plaque is cleared from the brain. If approved by the FDA, patients who have completed the biweekly IV initiation phase could transfer to the subcutaneous autoinjector 360 mg weekly maintenance regimen, currently under review. This would maintain effective drug concentrations to sustain the clearance of highly toxic protofibrils^[i] which can continue to cause neuronal injury even after the Aβ plaque has been cleared from the brain. The BLA is based on data from the Phase 3 Clarity AD open-label extension (OLE) study, and modeling of observed data.

Leqembi is now approved in the U.S., Japan and China, and applications have been submitted for review in the European Union, Australia, Brazil, Canada, Hong Kong, Great Britain, India, Israel, Russia, Saudi Arabia, South Korea, Taiwan, Singapore and Switzerland. In March 2024, Eisai submitted to the FDA a Supplemental Biologics License Application (sBLA) for less frequent monthly IV maintenance dosing of Leqembi.

Eisai serves as the lead of Leqembi development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority. BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

https://www.biospace.com/article/releases/eisai-initiates-rolling-biologics-license-application-to-us-fda-for-leqembi-lecanemab-irmb-for-subcutaneous-maintenance-dosing/

As Sales of Weight Loss Drugs Skyrocket, the Insulin Market Falters

 When the Inflation Reduction Act rolled out in January 2023, a key tenet of the legislation was the associated Affordable Insulin Now Act, which caps the price of insulin products at $35 per month for Medicare Part D enrollees. Two months later, Novo Nordisk announced that in response, the firm was going to chop the cost of various insulin products by up to 75%. By November, however, Novo changed its tune: Instead of lowering insulin product Levemir by 65%, the firm announced that it was discontinuing the medication instead. Both FlexPens and vials will be completely off the market by the close of 2024.

“[Novo] can’t make a product they’re losing money on, which may be the case with some insulins, and at some point they need to be smart with capital,” BMO Capital Markets analyst Evan Seigerman told BioSpace.

Meanwhile, Q1 sales across the Novo portfolio increased 24% year-over-year with quarterly revenue of $9.37 billion due to the sky-high sales of GLP-1 drugs Ozempic and Wegovy, approved for type 2 diabetes and weight loss, respectively.

In a similar move, weight-loss competitor Eli Lilly also slashed the cost of insulin drug Humalog by 70% to cost patients approximately $25 per vial. Then in March, the company reported that it was facing Humalog manufacturing constraints and warned that it may be temporarily out of stock of the drug by early April, though so far no shortages have been reported.

Also like Novo, Lilly reported strong sales of its GLP-1 weight-loss drug, Zepbound, which was approved last November. In Q1 2024, Zepbound’s first full quarter on the U.S. market, sales of $517.4 million beat analysts’ expectations of $373 million. While below Wegovy’s $1.34 billion in Q1 sales, new Zepbound prescriptions now outpace Wegovy scripts. Lilly also saw continued strong sales of Mounjaro, its GLP-1 for type 2 diabetes.

With such strong sales of GLP-1 drugs, questions arise about how crackdowns on insulin pricing will influence pipeline strategies and if pharma firms have a social responsibility to produce insulin, even at a loss. Moreover, if GLP-1s prevent obesity and diabetes on a mass scale, will insulin stay in such high demand?

Does Levemir’s Withdrawal From Market Really Matter?

Novo decided to discontinue Levemir in the U.S. “due to a combination of factors,” according to comments emailed to BioSpace, “most notably global manufacturing constraints, significant insurance formulary losses impacting patient access effective in January 2024 . . . as well the availability of alternative options in the U.S. market.”

Manny Jurado, principal at the life sciences consulting Dedham Group who works with both biopharma and digital health clients in the GLP-1 and insulin space, added that the complexity of the American healthcare system also played a role. “In the U.S., we definitely live in a higher complexity healthcare ecosystem driven by factors like private insurance and . . . vertically integrated organizations like Cigna-ESI [and] Aetna-CVS, which pretty much touch every aspect of healthcare at this point,” Jurado told BioSpace.

Considerations like differing state and federal regulations, as well as socioeconomic diversity of patients, makes it challenging for any pharma company to successfully launch their product to the American masses, Jurado said. As for insulin as a product, he said that there are other long-lasting insulins on the market, such as Tresiba, Lantus and Toujeo, among others, so patients are not being left without any insulin at all.

However, with pricing caps, the availability of those existing insulins may also change in the future. “I believe manufacturers will continue to re-evaluate their strategic approaches to insulin as supply continues to be an issue,” Jurado said.

How Are the GLP-1 and Insulin Markets Connected?

Jurado said that few drugs have ever gripped the American public like GLP-1 weight-loss drugs. With all of that media noise and accompanying sales, critics of discontinuing Levemir have questioned whether sales of Novo’s Wegovy and Ozempic could have helped subsidize its production.

Seigerman said that when it comes to the strength of GLP-1 sales, there is more that meets the eye. “Yes, on a per-product basis, Wegovy, Ozempic, Mounjaro, and others are profitable,” he said. “[But] you have to remember to get to where these products are now, billions upon billions of dollars were invested. It takes time to recoup; it’s not just the cost of goods.”

For now, Seigerman sees the question of GLP-1 success as a completely separate equation from insulin pricing and supply. “Insulin is unique,” he told said. “These products cost money to make, and [Medicare paying] $35 a month is never going to be able to recoup the cost [of production].” If Levemir were reimbursed at a more appropriate rate for the investment, Seigerman argued, the drug may not have been discontinued.

Seigerman added that the price caps also discourage drugmakers from developing insulin biosimilars. He noted that there are no biosimilars for Levemir—and that, he said, is the real problem in discontinuing the drug. “There should be biosimilars for these [insulins], and that begs the question of why there’s not.”

Future Entanglement of GLP-1s and Insulin Sales

Seigerman predicted that the rise of GLP-1s in popularity may impact the rates of diabetes and thus the need for insulin products because there is a “big overlap” between the obese population and diabetes patients. However, he said that it’s too early to tell how these markets will influence each other, and it may take a decade-plus for any such interplay to come to fruition.

Jurado acknowledged the common links between obesity, diabetes and cardiovascular indications, along with other chronic conditions that GLP-1s address, but emphasized that it’s not enough to trigger a massive phase-out of insulin. “There will always be a strong need for insulin,” he said.

Jurado said that drug manufacturers have social responsibility to people with diabetes—and that most recognize this. “I think these insulin manufacturers acknowledge that these drugs are truly life-time chronic [ones] and are finding ways to continue to support these patients and keep up with supply, despite these manufacturing challenges,” he said.

As for the withdrawal of Levemir, Seigerman is of the firm belief that Novo was justified in its decision and not at fault for the lack of a biosimilar. “In the world of pharma, if you have products losing money with no strategic benefit, you have to look at your portfolio and say, is this how we want to use our limited resources? You have to make capital allocation decisions in R&D, manufacturing, and getting the appropriate products to the right patient every time.”

https://www.biospace.com/article/as-sales-of-weight-loss-drugs-skyrocket-the-insulin-market-falters/

FDA Preparing For Possible Bird Flu Spread Among Humans: Commissioner

 by Zachary Stieber via The Epoch Times,

The U.S. Food and Drug Administration (FDA) is preparing for a scenario in which the highly pathogenic avian influenza starts spreading among humans, the agency’s commissioner said on May 8.

“This virus, like all viruses, is mutating. We need to continue to prepare for the possibility that it might jump to humans,” Dr. Robert Califf, the commissioner, told senators during a hearing in Washington.

The influenza, also known as the bird flu or H5N1, has recently started spreading among cattle and other species. One person in Texas has had a confirmed case this year.

Food and Drug Administration Commissioner Dr. Robert Califf in Washington in a file image. (Joe Raedle/Getty Images)

So far, genetic sequencing and other data indicate that influenza poses little risk to people, and there are no signs that the flu is transmitting from person-to-person, according to U.S. officials. But they are working on getting treatments, tests, and vaccines ready in case that changes.

“We’ve been busy getting prepared for if the virus does mutate in a way that jumps into humans on a larger level,” Dr. Califf told the Senate Appropriations Committee’s Agriculture Appropriations Subcommittee.

The patient in Texas primarily experienced one symptom: inflamed eyes. Neither the patient nor many of the cows that have been infected have suffered respiratory symptoms. H5N1 commonly infects the respiratory tracts of birds.

“The real worry is that it will jump to the human lungs, where, when that has happened in other parts of the world for brief outbreaks, the mortality rates have been 25 percent,” Dr. Califf said. The worry is based in part on how viruses typically mutate, such as in the case of COVID-19.

From 2003 to April 1, 2024, 889 cases of H5N1 have been confirmed across the globe, according to the World Health Organization (WHO). Of the patients, 52 percent have died.

WHO chief scientist Jeremy Farrar said recently that H5N1 has developed into a “global zoonotic animal pandemic” and that scientists are concerned that the virus could evolve to spread among humans.

Tedros Ghebreyesus, the director-general of the organization, said Wednesday that “the virus does not show signs of having adapted to spread among humans, but more surveillance is needed.”

Many experts consulted by the U.S. government are concerned about the jump of the influenza to cattle and other species and how cattle intermingle with pigs, chickens, and humans on farms, according to Dr. Califf. A May 3 study from U.S. and Danish researchers said testing of tissues from cattle indicated the animals could serve as a “mixing vessel” for avian influenza because receptors from chickens, ducks, and humans were expressed in the cows.

While the risk is still low, “if we institute the countermeasures now and reduce the spread of the virus now, then we’re much less likely to see a mutation that jumps to humans for which we’re ill-prepared,” Dr. Califf added.

Current U.S. rules mandate testing of some cattle before being moved to another state. The guidance includes advising workers on farms to wear protective equipment when dealing with animals that may be or are sick with the bird flu.

The FDA is focusing in part on ensuring the country’s milk supply is safe to drink. The agency and its partners have tested samples of milk from grocery stores. Although some samples tested positive, no live virus has been detected, meaning the milk supply is safe, according to the agency.

Test results from beef have also found beef is safe, according to the U.S. Department of Agriculture.

The agency has confirmed H5N1 infections in 36 herds across nine states, including Colorado, Kansas, and Michigan. Data from affected cows indicate H5N1 began circulating in cattle in late 2023, according to a preprint paper from the department.

About 70 farm workers are being monitored in Colorado, officials said in a briefing this week, but none have displayed symptoms as of yet.

https://www.zerohedge.com/medical/fda-preparing-possible-bird-flu-spread-among-humans-commissioner-0