Apparently Mr. Market is very much NOT impressed by this addition to the BOD.

Has been for quite a while,... Not exactly a noteworthy point.

CEL-SCI Appoints Mario Gobbo to Its Board of Directors
9:00 AM ET 4/23/24 | BusinessWire
VIENNA, Va.--(BUSINESS WIRE)--April 23, 2024--

CEL-SCI Corporation (NYSE American: CVM) today announced the appointment of Mario Gobbo to its Board of Directors.

Mr. Gobbo has nearly 40 years of banking and corporate finance experience in healthcare and energy. His expertise encompasses venture capital and private equity as well as investment banking and strategic advisory services. He has served as an officer or director for a number of companies including several biotech companies: Xcovery, Ocimum/Genelogic and Helix BioPharma. Prior to that, Mr. Gobbo worked in the financial industry for Lazard LLC, Swiss Bank Corporation, the European Bank for Reconstruction and Development, Natixis Bleichroeder, Inc., and International Finance Corporation (the private sector arm of the World Bank). Mr. Gobbo holds a Bachelor of Arts in Organic Chemistry from Harvard College, a Master of Science in Biochemistry from the University of Colorado and an MBA, a Master of Business Economics and a PhD (Management) from the Wharton School of the University of Pennsylvania.

"Mr. Gobbo has a unique background where science and Wall Street interact to create new medicines. He has backed many successful healthcare ventures and he has excellent contacts in that part of finance that is interested in building medical breakthroughs into great companies. We are honored to receive his help in bringing Multikine to market as a treatment for head and neck cancer," stated CEL-SCI CEO Geert Kersten.

Mr. Gobbo commented, "This is an exciting and extremely important moment to join the board of CEL-SCI as it is on the brink of developing a product that will revolutionize certain head and neck cancer therapies and probably other deadly cancers. I am proud and honored to become part of the CEL-SCI team."

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. Multikine* (Leukocyte Interleukin, Injection) is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. In a Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck (oral cavity and soft-palate) with the investigational product Multikine administered first, before they received the standard of care, which involved surgery followed by either radiation or chemoradiation. The Phase 3 study enrolled 928 patients. Our approach is unique because most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed.

After analyzing data from the Phase 3 study, we have better defined the target head and neck cancer population for Multikine, which is advanced primary head and neck cancer patients with no lymph node involvement and with low PD-L1 tumor expression. In the Phase 3 study, we observed statistically significant survival data in the final target population, showing that Multikine cut the risk of death in half at five years vs control.

Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2023. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240423365855/en/

CONTACT: Gavin de Windt
CEL-SCI Corporation
(703) 506-9460

SOURCE: CEL-SCI Corporation
Copyright Business Wire 2024

> Dow Jones Newswires

April 23, 2024 09:00 ET (13:00 GMT)

Well - we're about half through 'the month' now and we could use some positive news,....

Up more than 15% today on decent volume. I can't find any actual news that might be driving a rise today though.

Not a great day for us shareholders,... I wonder what the 'looming' bad news is that's driving this?

Problem is - they need to actually finish their Phase I a/b trial and get the data in some publishable, or regulatory agency submit-able form before anybody is going to let them set up a Phase II trial for anything, including COVID.

I think that LEAPS has a ton of potential. That's a fact. However, LEAPS is a developmental-stage platform that's many years, and lots of $$s away from being anything other than a developmental-stage platform.

If Multikine doesn't pull this company up and start generating revenue, LEAPS will never be more than just a clever idea.

IMO you're on the right track with your bit about the history of drawn-out finance deals. But I would assert that in addition the long, long, long delays in getting their Phase III rolling soiled the management's reputation. That initial CRO flaking out on them really put a crimp on their getting the trial ramped up - that cost them a couple of years, a lot of both financial and social capital.

Then the study post-treatment period ended up being longer than was stated it would be. Then it took forever to get the data locked, analyzed, and the initial whole-cohort population (as a whole) didn't appear to meet the primary endpoints for success. Then it took them what seemed like years to get the biomarkers for the target subpopulation and the patient assessment criteria in place.

Recent financing of operations has at least been generally transparent. In the past, that definitely could not be said to be true.

They do appear to have at least most of their ducks in a row and marching steadily forward now. That's promising.

It's a very positive letter for us shareholders, the company, and potentially for a lot of cancer patients.

It's only a matter of time now. :D

OK - so maybe the management can restart a clinical trial,.... Cool!

How are they going to pay for it? Clinical trials are not cheap, and this company has transparent cash reserves.

Accurate assessment.

That author is usually fairly bearish - but this article is relatively evenhanded for him/her.

I absolutely get the need to raise money - but why do the keep undercutting the market by so much when they do so? Ugh.

Might have to use this opportunity to gather in some more shares at a discount next week though.

CEL-SCI Completes Commissioning of Its Multikine Manufacturing Facility for Commercial Scale Production of Head
9:00 AM ET 2/6/24 | BusinessWire

Marks key achievement that is a prerequisite to filing a Biologics License Application with the FDA and other regulators for marketing approval
VIENNA, Va.--(BUSINESS WIRE)--February 06, 2024--

CEL-SCI Corporation (NYSE American: CVM) today reported that its Multikine(R) (Leukocyte Interleukin, Injection)* cGMP state-of-the-art dedicated manufacturing facility commissioning has been completed.

"This is a very significant milestone in bringing Multikine to market since the manufacturing facility is part of a planned Biologics License Application required for approval of Multikine in the treatment of head and neck cancer," stated CEL-SCI's CEO Geert Kersten.

"The high degree of complexity involved in manufacturing Multikine has required tremendous investment and time on CEL-SCI's part. Our manufacturing trade secret, capability, and know-how are high-value key strategic assets that would be very difficult for others to replicate. This achievement marks a very big step towards the preparation of Multikine for marketing approval," Kersten added.

Originally constructed to supply Multikine for the world's largest global pivotal Phase 3 trial in locally advanced squamous cell carcinoma of the head and neck, CEL-SCI's facility has been expanded and upgraded in preparation for the Company's submission of Multikine for regulatory approval and commercial scale manufacturing. In keeping with CEL-SCI Validation Master Plan, industry standards, International Society for Pharmaceutical Engineering (ISPE) guidelines, International Conference for Harmonization (ICH), and in compliance with regulatory guidelines, CEL-SCI undertook commissioning and qualifying the facility's utilities, systems, and equipment.

About CEL-SCI Corporation

CEL-SCI believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. In a Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck (oral cavity and soft-palate) with the investigational product Multikine administered first, before they received the standard of care, which involved surgery followed by either radiation or chemoradiation. The Phase 3 study enrolled 928 patients. Our approach is unique because most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed.

After analyzing data from the Phase 3 study, we have better defined the target population, which is advanced primary head and neck cancer patients with no lymph node involvement and with low PD-L1 tumor expression. In the Phase 3 study, we observed statistically significant survival data in the final target population, showing that Multikine cut the risk of death in half at five years vs control. We plan to submit the proposed study protocol to the FDA in Q1 2024, with the goal to get FDA buy-in for a confirmatory clinical trial, and also to discuss potential accelerated approval pathways.

Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.

The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the progress and timing of, and the amount of expenses associated with, our research, development and commercialization activities for our product candidates, including Multikine; (ii) our ability to duplicate the clinical results demonstrated in clinical studies, (iii) the timely development of any potential products that can be shown to be safe and effective, (iv) receiving necessary regulatory approvals, (v) difficulties in manufacturing any of the Company's potential products, (vi) our liquidity and ability to raise the necessary capital on acceptable terms, if at all. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the fiscal year ended September 30, 2023 filed with the SEC on December 21, 2023 and the other reports we will with the SEC. You are urged to read these documents free of charge on the SEC's web site at http://www.sec.gov. The Company encourages you to consider all of these risks, uncertainties and other factors carefully in evaluating the forward-looking statements contained in this press release. As a result of these matters, changes in fact, assumptions not being realized or other circumstances, the Company's actual results may differ materially from the expected results discussed in the forward-looking statements contained in this press release. The forward-looking statements made in this press release are made only as of the date of this press release, and the Company undertakes no obligation to update them to reflect subsequent events or circumstances.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240206088192/en/

CONTACT: Gavin de Windt

CEL-SCI Corporation

(703) 506-9460

SOURCE: CEL-SCI Corporation
Copyright Business Wire 2024

Perhaps because 1) The pre-clinical studies already pretty much established that point & 2) That wasn't actually the point of the Phase I trails?

BTW - my previous comment wasn't passive aggressive. It was blunt and to the point.

You already knew the answer. You were, yourself, being passive aggressive.

You're entitled to your opinion - even when it is incorrect. Have a good afternoon.

You can read it as well as I can. The PR doesn't actually show 'the actual data' - but does go through the dosing schemes for both oral gummies and liquid forms that were the tested concentrations of NV-387.

The PR also makes a similar statement in the section talking about the lack of toxicity in all of the pre-clinical (animal and other model systems) that they tested the compounds in

Safety in Multiple-Ascending-Dose Healthy Subjects Clinical Trial Part Successfully Established for the NanoViricides Ultra-Broad-Spectrum Antiviral Drug NV-CoV-2 with No Adverse Events Found
6:31 AM ET 1/29/24 | Dow Jones

SHELTON, CT / ACCESSWIRE / January 29, 2024 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today that the healthy subjects part of the Phase 1a/1b Clinical Trial of NV-CoV-2 was completed successfully. No adverse events were reported in any of the multiple ascending dose cohorts, confirming the excellent safety of NV-387, the active ingredient in NV-CoV-2.

NV-387 is highly active against many respiratory viruses; all tested Coronaviruses and RSV among them. NV-387 was designed to mimic the host-side feature called "sulfated proteoglycans" ("S-PG"), presenting a biomimetic of S-PG on the surface of the nanoviricide that mimics a biological cell membrane. Over 90% of human pathogenic viruses use S-PG receptors to cause infection, and many of them are expected to be susceptible to NV-387.

NV-387 is designed to attack the viral surface and disable the virus from being able to infect cells. This is reminiscent of how antibiotics such as penicillins attack bacterial surface and dismantle the bacteria.

This ultra-broad-spectrum, cross-virus-families, antiviral activity of NV-387 is expected to revolutionize not only the treatment of viral infections but also how we respond to potential pandemics in a significantly more rapid fashion than what happened with COVID-19.

Viral variants are unlikely to escape the nanoviricide drug (i) because even as the virus mutates it still binds to the same host-side features, that the nanoviricide copies; and (ii) such escape is not expected based on the extremely wide spectrum of activity of NV-387, across multiple viruses in each family and across distinct virus families.

All clinical trial subjects were held in the hospital during treatment period. All of them have been discharged and all of them have also gone through the final post-discharge follow-up visit. There were no adverse events reported during treatment or through the follow-up visit. Clinical observations during the in-hospital sequestration did not show any adverse events. No adverse events were reported from lab reports of the subjects for various blood tests, organ function tests, or ECG (heart). There were no dropouts.

These results are indicative of an excellent safety profile of NV-387. These results are consistent with the excellent safety characteristics observed for NV-387 in the pre-clinical studies.

NV-387 has been found to be non-immunogenic, non-allergenic, non-mutagenic, as well as non-genotoxic in various pre-clinical animal model studies leading to the clinical trials. No adverse effects were reported in GLP Safety-Toxicology studies in multiple animal models including non-human primates (NHP, Cynomolgus monkeys). The NOAEL (No-Observed-Adverse-Events-Level) was 1,200 mg/Kg and MTD (Maximum Tolerable Dose) was 1,500 mg/Kg in rats, which indicate excellent safety.

In contrast, most known antiviral drugs have significant dose-limiting toxicities.

The human subject pharmacokinetic (PK) plasma samples have been duly received at the GLP bioanalytical lab in the USA and will be analyzed shortly.

Two different drug products, (i) NV-CoV-2 Oral Syrup, 100mg/mL, and (ii) NV-CoV-2 Oral Gummies, strengths of 500mg and 1,000 mg were in the study. There were three dosing cohorts for each of the drug products.

The Phase1a-Healthy Subjects part was a Single-Ascending-Dose trial, that was successfully completed with no adverse events found, as reported previously in a press release on November 28, 2023.

The Phase1b-Healthy Subjects part was a Multiple-Ascending-Dose trial. The dosing of NV-CoV-2 Oral Syrup was at nominal 10mg/Kg, 20mg/Kg and 40mg/Kg levels, with the first dose being double the nominal amount (a "loading dose"). The dosing of NV-CoV-2 Oral Gummies was at nominal 500mg, 1,000mg, and 2,000mg levels, with the first dose being double the nominal amount (a "loading dose"). In all cohorts, there was a double dose on first day, followed by single doses every 48 hours for a total of five dosing instances (i.e. 6 total nominal doses) over a period of 9 days.

The clinical trial will now undergo data-lock procedures and thereafter biostatistical analyses will be conducted. The final report will become available afterwards.

The Phase 1a/1b clinical trial is being managed by our collaborator and licensee in India, Karveer Meditech Pvt. Ltd., Kolhapur, India, who is also the drug sponsor in India. The trial is being conducted by the clinical research organization (CRO) Pristyn CR Solutions Pvt. Ltd., Aurangabad, India at the Mahatma Gandhi Mission's Medical College & Hospital, Aurangabad, India, as previously described.

About NanoViricides

NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide(R) class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2, that contains the active pharmaceutical ingredient ("API") NV-387, for the treatment of COVID caused by SARS-CoV-2 coronavirus. NV-CoV-2 in Phase 1a/1b human clinical trials for evaluation of safety and tolerability in healthy volunteers and COVID patients, as well as initial indications of effectiveness in COVID patients.

The same API, NV-387, was recently demonstrated to be active against RSV as well as against ectromelia virus, a mouse model virus used for smallpox drug development.

Our other advanced candidate is NV-HHV-1 for the treatment of Shingles.

The Company cannot project exact dates for the regulatory activities in progressing its drug candidates because of the Company's significant dependence on external collaborators and consultants.

The Company is currently focused on advancing NV-CoV-2 through Phase I/II clinical trials.

NV-CoV-2 is the Company's nanoviricide drug candidate for COVID. NV-CoV-2-R is another drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already approved drug, encapsulated within its polymeric micelles. 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 a broad pipeline of drugs against a number of viruses, with preclinical safety and effectiveness successes achieved already in many cases. NanoViricides' platform technology and programs are based on the TheraCour(R) nanomedicine technology of TheraCour, Inc., which TheraCour licenses from AllExcel, Inc. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms 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 Coronaviruses. The Company intends to obtain a license for poxviruses, enteroviruses, RSV and other viruses that it engages into research for, if the initial research is successful. TheraCour has not denied any licenses requested by the Company to date. 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.

Disclosure Statement

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 that are, in some cases, beyond the Company's control and that 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. In particular, 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 in human clinical trials to lead to a successful pharmaceutical product, including our coronavirus drug development program.

Contact:


2024-01-29 11:31:00 GMT Safety in Multiple-Ascending-Dose Healthy -2-

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

And more nothing,... And it's almost February. One would think that the Phase 1b would be underway and that they might have some news to report by this point.

And more nothing and it's almost February,....

Well - doesn't look that we are going to hold above $3 for the moment anyway. I'll be pleasantly surprised though if we do. However, it does generally look like the company is heading the right directions going into 2024.

Nothing going on that I am aware of. I don't expect to hear anything too interesting before Q2 of 2024 other than they might have to raise another small bit of operating capital during Q1. That ~$5MM that they raised back a couple of months ago is about what their corporate cash burn rate per quarter has been the last year or so.

Their corporate 2023 EOY report documents came out on the 22nd - maybe somebody just noticed it?

It's certainly nice to see this stock nudging back over $3/share again. $3.08 as of this writing and good volume as well.

Rumor mill over on Stocktwits is that STELLAS is about to receive Orphan Drug status for their T-cell lymphoma treatment. No PR out yet but,.... Dated today,...

https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=977523

Well - If what that last set of PRs/updates us accurate - and the NV-387 candidate drug may also be effective against other viruses with the same attachment points - they could just use the existing Phase 1a/b data for COVID treatment and plan a Phase II against something else. The Phase I studies are primarily focused on safety and dosage testing. Those safety/dosage data should also be applicable to treating other viruses.

That last PR back right after Thanksgiving specifically mentioned RSV as something that could be aimed at as well as other coronaviruses. There's definitely a market there and another significant medical problem that doesn't appear to be going away even if COVID is more under control than it used to be.

I wonder if there will be any news to relay regarding the Phase 1b progress by January 13th?

Assuming nothing too choppy happens during early 2024 - I do think that CVM share prices 'only' rising to $8.40 might be a significant underestimate by end of H2 2024.

But we shall see and I ain't going anywhere in the meantime.
Cheers and thanks for sharing this!

IMO - if NICE does complete a review of Multikine and they say it belongs in the Great Britain SOC for head and neck cancer, then what the FDA choses to do is just a bonus in a lot of ways. The GB medical system - despite Brexit - still has close ties to what the rest of the EU does. And since H&N cancer is reportedly more abundant in Europe than in the US, that market is enough to drive share prices up to at least at the $25 level.

All I know is that we are likely in for an interesting, and positive, 2024 and beyond with CVM. I have been here in at least a small way since about 2009-10, but didn't really start adding much until after the Phase III trial results were revealed.

I'm feeling pretty darned good about those shares that I have added during 2023 at around the $2.30 ranges,...

UKS National Institute for Health and Care Excellence (NICE) Selects CEL-SCIs Multikine as Potential New Standard of Care for Head
8:30 AM ET 12/4/23 | BusinessWire
VIENNA, Va.--(BUSINESS WIRE)--December 04, 2023--

CEL-SCI Corporation (NYSE American: CVM) today announced that the British National Institute for Health and Care Excellence (NICE) has selected Multikine* (Leukocyte Interleukin, Injection) to be evaluated as the potential new standard of care for squamous cell carcinoma of the head and neck (SCCHN) in the UK. NICE posted a detailed report from the UK's National Institute for Health and Care Research (NIHR) regarding Multikine, its clinical data, and its potential to become a better standard of care in treating newly diagnosed head and neck cancer in the UK. This published report informs UK doctors, patients, and other interested parties that NICE has started the review of Multikine and is soliciting public comment.

As stated on NICE's website (click here), the reason for selecting Multikine is the following:

"Anticipate the topic will be of importance to patients, carers, professionals, commissioners and the health of the public to ensure clinical benefit is realised, inequalities in use addressed, and help them make the best use of NHS resources"

A detailed Health Technology Briefing prepared by the NIHR posted on NICE's website (click here) titled "Leukocyte interleukin with cyclophosphamide, indomethacin, and zinc for neoadjuvant therapy of squamous cell carcinoma of the head and neck" can viewed in full HERE.

The NICE briefing includes the following statements:
-- "The current standard of care for locally advanced SCCHN is an
aggressive combined modality therapy. With current treatment the risk of
recurrence, distant metastases, and death (5-year survival rate) for
patients remains high."

-- "With current standard of care, most patients with SCCHN still
experience disease recurrence or develop distant metastases (spread to
distant organs or lymph nodes), therefore novel treatment options are
needed."

-- "The LI injection [Multikine] utilizes naturally occurring,
immune-regulating cytokines, and could be the first investigational
immunotherapeutic to be used in locally advanced SCCHN. Results from
phase III clinical trial (NCT01265849) indicated a statistically
significant 5-year survival benefit with LI immunotherapy produced in
patients receiving surgery plus radiotherapy, representing approximately
40% of the study population."

-- "If licensed, LI [Multikine] will offer the first-line neoadjuvant
treatment in previously untreated patients with SCCHN prior to standard
of care."

Dr. Mehmet Sen, MD, FRCR, one of Europe's leading head and neck oncologists treating patients for more than 30 years, and Consultant Clinical Oncologist and Honorary Senior Lecturer at the St. James Institute of Oncology in Leeds, UK, commented, "There is a clear and imperative need for a new treatment for newly diagnosed head and neck cancer patients in the UK and worldwide. Multikine's efficacy and safety data are clear and compelling. Moreover, because Multikine can be administered before the current standard of care of surgery and radiation, it has strong potential to be additive to survival at minimal additional risk, if any, to the patient."

"We are highly encouraged that NICE has selected Multikine for evaluation as a potential new standard of care for head and neck cancer. This is a big step forward in the UK," stated CEL-SCI CEO Geert Kersten.

NICE is an executive non-departmental public body of the Department of Health and Social Care in the UK. NICE publishes guidelines in four areas:
-- the use of health technologies within England's National Health Service
(NHS) and NHS Wales (such as the use of new and existing medicines,
treatments and procedures)

-- clinical practice (guidance on the appropriate treatment and care of
people with specific diseases and conditions)

-- guidance for public sector workers on health promotion and ill-health
avoidance

-- guidance for social care services and users.

These appraisals are based primarily on evidence-based evaluations of efficacy, safety and cost-effectiveness in various circumstances.

According to Cancer Research UK, an average of 12,400 cases of head and neck cancer are diagnosed each year in the UK.

About CEL-SCI Corporation

CEL-SCI is a clinical-stage biotechnology company focused on activating the immune system of cancer patients to fight cancer before surgery, radiation and chemotherapy have damaged it. The Company's lead investigational therapy Multikine completed a pivotal Phase 3 clinical trial involving head and neck cancer, for which the Company has received Orphan Drug Status from the FDA. The Company has operations in Vienna, Virginia, and near Baltimore, Maryland.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2022. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231204232873/en/

CONTACT: Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
SOURCE: CEL-SCI Corporation
Copyright Business Wire 2023

> Dow Jones Newswires

December 04, 2023 08:30 ET (13:30 GMT)

The Phase 1a/1b Human Clinical Trial of NV-CoV-2, the Company's Broad-Spectrum Antiviral Drug, Has Successfully Completed the First Part (Phase 1a), Reports NanoViricides

6:41 AM ET 11/28/23 | Dow Jones

SHELTON, CT / ACCESSWIRE / November 28, 2023 / NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today that the Single-Ascending Dose part of the Phase 1a/1b Human Clinical Trial of NV-CoV-2, the Company's broad-spectrum antiviral drug, was completed successfully. Recruitment for the Multiple-Ascending Dose part was also completed. The drug NV-CoV-2 contains the Company's nanoviricide active agent, NV-387, which has shown strong broad-spectrum antiviral activity not only against multiple coronaviruses, but also against RSV and in a model for Smallpox therapeutics.

The Phase 1a Clinical Trial Part, namely Single-Ascending-Dose in Healthy Volunteers, Was Completed Successfully:

The Company reports that its Indian collaborator and drug sponsor, Karveer Meditech Pvt. Ltd., India, has communicated that all 36 healthy volunteers in the various cohorts in the Phase 1a Single-Ascending-Dose ("SAD") clinical trial have now completed the study. Follow-up visit was also concluded for all of the Phase 1a volunteers. Previously, we reported on August 21, 2023 that 26 of the 36 healthy volunteers had completed the Phase 1a study.

No Adverse Events Found in the Healthy Volunteers Cohorts to Date:

No adverse events or serious adverse events were found at any of the three dose levels studied, in either of the two formulations, namely (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies, in the completed Phase 1a (Single Ascending Dose) part of the study.

To note, we have previously reported that no adverse events or serious adverse events were found in either of the two formulations, namely (i) NV-CoV-2 Oral Syrup, and (ii) NV-CoV-2 Oral Gummies, in the 26 out of 36 healthy volunteers that had completed the Phase 1b part (Multiple-Ascending Dose) of the study.

Recruitment for Multiple-Ascending-Dose Clinical Trial (Phase 1b) in Healthy Volunteers Was Completed:

Additionally, the remaining 10 healthy volunteers have been recruited into the Multiple-Ascending Dose part of the Phase 1b study, completing the targeted 36 volunteers recruitment.

"The excellent safety of NV-CoV-2 formulations is expected to enable use of the drug across all patient population, from young children, otherwise healthy persons, to immune-compromised persons, persons with advanced age with or without co-morbidities," said Anil R. Diwan, Ph.D., Executive Chairman and President of the Company, adding, "We await completion of the multiple-ascending dose portion of this trial in healthy volunteers which is expected soon. Thereafter we plan on advancing NV-387 for the treatment of several different viruses that this drug has shown strong activity against."

NV-387 Has Shown Broad-Spectrum Antiviral Activity Across Multiple Virus Families:

NV-387 was found to be as effective as ribavirin, the toxic last resort drug, against RSV infection in a lethal lung infection animal model, as reported previously. RSV is a virus particularly threatening to vulnerable infants, young children, older adults, and immunocompromised populations.

There is no approved drug for the treatment of RSV infection, except the toxic drug ribavirin which is only indicated for very severe cases due to its severe hemotoxicity.

The market size for RSV therapeutics has been estimated to be approximately $2 Billion rising to $8 Billion.

Additionally, we recently reported that NV-387 was as effective as the approved drug tecovitrimat (TPOXX(R), SIGA), in a lethal intra-digital infection by ectromelia virus in mice. Importantly, a combined drug made from NV-387 and tecovirimat was more effective than either drug alone, indicating NV-387 "plays well" with tecovirimat and acts by a different mechanism.

Smallpox poses a significant biodefense threat. Ectromelia virus is a native virus of mice in the poxvirus family and is one of the key animal model viruses for developing smallpox therapeutics. Tecovirimat is an approved drug for treating smallpox infection based on the FDA "Animal Rule", and is stockpiled by the US "Strategic National Stockpile". It was mobilized during the recent monkeypox epidemic. It is important to develop additional smallpox therapeutics that work well with tecovirimat and by themselves, since viruses pose the threat of drug escape by mutation; further, in a bio-terrorism scenario, a human-engineered smallpox virus resistant to existing drugs could be a potential threat.

NV-387 Acts by a Novel Mechanism:

We developed NV-387 in response to the COVID pandemic as a broad-spectrum, pan-coronavirus antiviral. It is designed to "look like a cell" to the virus, displaying copious amounts of sites to which the virus binds on the surface of the nanoviricide nanomicelle, to trap and destroy the virus particle, rendering the virus incapable of infecting another cell.

We call this novel antiviral mechanism "Re-Infection Blocker".

NV-387 Could Revolutionize Antiviral Treatment Just As Antibiotics Did Against Bacteria:

In particular, NV-387 was designed to emulate an "attachment receptor family" called sulfated proteoglycans (S-PG), that over 90% of human pathogenic viruses are known to use for infecting cells. Therefore, in addition to Coronaviruses, RSV and Smallpox, we anticipate that NV-387 may have effectiveness against many other viruses. We plan on continuing to study the antiviral spectrum of NV-387 with a view to expand its applications.

NV-387 could usher in a new era in the treatment of antiviral infections, if it is found to be broadly effective against additional viruses that use S-PG, evoking a comparison to how antibiotics changed the treatment of bacterial infections.

NV-387 Addresses an Unmet Medical Need for Broad-Spectrum, Safe and Effective Antiviral Drug That Works Against Multiple Viral Threats:

There is a significant unmet medical need for a broad-spectrum antiviral drug that is effective and useable in all segments of the population. There are substantial limitations for all currently approved COVID drugs in terms of both the eligibility of a COVID patient, and the effectiveness of the drug.

We believe that the excellent safety and the distinctly different mechanism of NV-CoV-2 (NV-387) support the use of this drug across all patient populations. This is an important characteristic for a COVID drug as well as for a drug to treat RSV infection.

NV-387 Addresses Large Market Sizes:

In addition to the well-known strong and continuing market size for COVID drugs, GrowthPlus Reports, in June 2023, has said that the market size for RSV therapeutics was worth $1.8 Billion in 2022, and is expected to grow at a CAGR of 18.9%, reaching $8.73 Billion by 2031.

About NanoViricides

NanoViricides, Inc. (the "Company") (www.nanoviricides.com) is a clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company's novel nanoviricide(R) class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. Our lead drug candidate is NV-CoV-2, that contains the active pharmaceutical ingredient ("API") NV-387, for the treatment of COVID caused by SARS-CoV-2 coronavirus. NV-CoV-2 in Phase 1a/1b human clinical trials for evaluation of safety and tolerability in healthy volunteers and COVID patients, as well as initial indications of effectiveness in COVID patients.

The same API, NV-387, was recently demonstrated to be active against RSV as well as against ectromelia virus, a mouse model virus used for smallpox drug development.

Our other advanced candidate is NV-HHV-1 for the treatment of Shingles.

The Company cannot project exact dates for the regulatory activities in progressing its drug candidates because of the Company's significant dependence on external collaborators and consultants.

The Company is currently focused on advancing NV-CoV-2 through Phase I/II clinical trials.

NV-CoV-2 is the Company's nanoviricide drug candidate for COVID. NV-CoV-2-R is another drug candidate for COVID that is made up of NV-CoV-2 with Remdesivir, an already approved drug, encapsulated within its polymeric micelles. 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 a broad pipeline of drugs against a number of viruses, with preclinical safety and effectiveness successes achieved already in many cases. NanoViricides' platform technology and programs are based on the TheraCour(R) nanomedicine technology of TheraCour, Inc., which TheraCour licenses from AllExcel, Inc. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms 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 Coronaviruses. The Company intends to obtain a license for poxviruses, enteroviruses, RSV and other viruses that it engages into research for, if the initial research is successful. TheraCour has not denied any licenses requested by the Company to date. 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.

Disclosure Statement

2023-11-28 11:41:00 GMT The Phase 1a/1b Human Clinical Trial of NV-CoV-2, -2-

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 that are, in some cases, beyond the Company's control and that 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. In particular, 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 in human clinical trials to lead to a successful pharmaceutical product, including our coronavirus drug development program.

CONTACT:

NanoViricides, Inc.

info@nanoviricides.com

Public Relations Contact:
MJ Clyburn
TraDigital IR
clyburn@tradigitalir.com
SOURCE: NanoViricides, Inc.

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And back up we go again,....

There are only two days when I care about share prices. These are the day (or days) when I chose to buy shares, and the day (or days) when I chose to sell them.

Your comparison here to a stock split doubling my share value is nonsense. Thanks for 'participating in the conversation' though.

A couple of weeks ago the share price was $2 or less. I'm guessing that $2 is what price that CVM could negotiate with whomever big-wig was willing to fork over that much operating capital. It's not the company's focus to maintain a particular share price for short-term traders or newly acquired shareholders looking for a quick score.

It's the company's focus to get Multikine to market, to start generating regular revenue on its own, or to attract interest from a big partner or buy-out pharma. To do that the company needed a sizable chunk of operating capital to keep moving forward. The price to the company for that new chunk of operating capital was a discount for the big investor who could provide that needed capital in the near term.

I bought some new shares this morning at around $2.30. Yeah, sure, they are down even a bit more since then, but I don't focus any money I invest in short-term gains/losses. When Multikine gains regulatory approval - be that in the EU, Great Britain, Canada or with the FDA - that resulting gain in share prices is going to be extremely substantial. Ditto with a buyout - if that's what ends up happening.

How does that recent Warren Buffett quote go: "The stock market is a device for transferring money from the impatient to the patient."

A bit of dilution - but not much compared to the total number of shares. We all kind of figured that something like this was going to happen and I think that the market is just doing it's usual bit of overreacting.

We'll see how this plays out today and Friday as the market digests this happening.

As expected - there was no real share price bounce from the information that the 'Cide currently in testing is also good for animal models against other viruses. Nothing consistently good is going to happen unless and until there is a positive Phase I result, and until after NNVC figures out how it is going to finance a larger Phase II trial.