BALANCING LIFES ISSUES, INC. Alternative Medicine Fact or Fiction?
2016-01-23 NanoViricides Inc Fact Sheet.pages
Transcript of 2016-01-23 NanoViricides Inc Fact Sheet.pages
Summary NanoViricides, Inc. is a development-‐stage therapeu9cs company crea9ng special-‐purpose nanomaterials for an9-‐viral drugs based on a novel, first-‐in-‐class mechanism. The Company's novel nanoviricide® class of drug candidates are designed to specifically aBack enveloped virus par9cles, on the same sites that they use to bind to cells, and dismantle them. Our approach promises that a virus cannot escape our nanoviricide drugs due to muta9ons.
NanoViricides is unique in the field also in that we now have our own mul9-‐kg-‐scale c-‐GMP-‐capable clinical drug manufacturing capability. This facility is an9cipated to enable rapid transla9on to the clinic (as opposed to using an external manufacturer) of our drug candidates. Further, it should allow produc9on of ini9al marke9ng quan99es and thus early revenues from our first drug when licensed, which could be as high as $50MM to $500MM per year, depending upon the drug and pricing.
Our broad-‐spectrum an9-‐influenza drug, injectable FluCide™, for hospitalized pa9ents is our lead candidate. Our an9-‐herpesvirus drugs program is expected to develop into four drugs against different indica9ons, namely, oral herpes, genital herpes, herpes kera99s (eye), and shingles. NanoViricides, Inc. is possibly the first in the world to have developed an orally effec9ve nanomedicine, our oral FluCide™ for out-‐pa9ents. We are also developing drugs against Dengue viruses, and HIV. In addi9on, we have R&D programs against Ebola/Marburg, Rabies, MERS, and other viruses. All of our drugs are in pre-‐clinical development, with Influenza drugs in IND-‐enabling studies, and an9-‐Herpes drugs to enter IND-‐enabling studies soon. The Company’s DengueCide™ broad-‐spectrum treatment for Dengue and DHF has been awarded an “orphan drug” designa9on by the US FDA as well as the EMA. In addi9on, the Company’s an9-‐HIV drug candidate, HIVCide™, has shown strong efficacy in animals, sugges9ng it could possibly lead to a “func9onal cure” for HIV/AIDS.
State of the Art cGMP-‐capable Manufacturing Facility for Clinical Drug Produc=on is Ready for Opera=ons The new NanoViricides facility in Shelton, CT, facility contains customizable mul9-‐product cGMP manufacturing capability, as well as advanced nanomedicines characteriza9on and R&D laboratory, to support clinical drug manufacture of any of our drug candidates.
Manufacturing Scale to Support Ini=al Marke=ng Needs This facility has the capacity for market entry-‐level produc9on of our FluCide™ Injectable drug candidate for hospitalized pa9ents, or our eye an9viral drug for herpes kera99s, among others, when approved. Further, the facility has the capability to manufacture all of the drug needed for trea9ng a small epidemic outbreak, such as the recent Ebola crisis.
cGMP Manufacturing capability is a major risk for new pharma companies, especially in nanomedicines. We are happy to report that we are tackling this risk head on, by building our own.
Page � of �1 4
INVESTMENT HIGHLIGHTS
Company Fact Sheet
NYSE-MKT:NNVC
Large Class 10,000 Fume Hood Area for Synthetic Chemistry
Large Class 100 Cleanroom Area for
Injectables Manufacture
BIND ENCAPSULATE DESTROY
UNIQUE, NOVEL MECHANISM ENABLES FIRST IN CLASS PRODUCTS
Preclinical Products Address Large Markets, $40-‐70 Billion es=mated: HerpesVirus Mul=ple Drugs Franchise as well as FluCide Mul=ple Drugs Franchise Could Result in Treatment-‐Transforma=ons and Market Size Explosions Using the nanoviricides® plagorm technology, the Company has developed drug candidates targe9ng some of the world’s most pervasive viruses (see the table at top right and product pipeline on next page). The combined commercial market for our drug candidates has been es9mated well in excess of $40 to $70 Billion.
Whenever an effec9ve drug is developed addressing an unmet need, very large new markets appear (ex.: Lipitor, Sovaldi). We an9cipate such market explosion due to transforma9ve treatment could happen for some drugs in our FluCide franchise, in our an9-‐Herpes drugs franchise, and possibly many other drugs in our pipeline.
Key Issue of Drug Resistance from Viral Muta=ons is Unlikely with Nanoviricides Drugs due to Unique Biomime=c Technology The nanoviricide® technology plagorm mimics the host cell. We design and develop a virus-‐binding ligand that mimics the site on the host cell receptor to which the virus binds. This ligand is then chemically aBached to a special polymer to make a nanoviricide®. The virus is expected to be fooled into binding to the nanoviricide, like a venus-‐fly-‐trap. The nanoviricide is then expected to engulf the virus and possibly destroy it. To the extent that the ligand accurately maps to the receptor binding, the virus would not be able to escape the nanoviricide no maBer how much it mutates, because such mutants would not be able to bind efficiently to the natural receptor, unable to cause much disease.
Beyond An=bodies and Vaccines: A Nanoviricide is A Nanomachine that Completes the Task of Destroying Virus without Help from the Pa=ent’s Immune System An9bodies have been developed as drugs against viruses. However, an an9body only binds by two points to the virus. Moreover, the pa9ent’s immune system needs to be healthy for the clearance of the complex by the bodily systems of complement fixa9on and immune response. This is hardly the case when a viral infec9on takes over. Vaccines only train the body into producing an9bodies against the virus in the vaccine. Because an9bodies are highly specific, an9bodies and vaccines are easily overcome by viruses due to rapid muta9ons in the field. Note that the 2015 influenza seasonal vaccine was only 23% effec9ve!
In contrast, a nanoviricide should work against all strains of the virus because they s9ll bind the same way to the same host cell receptor. A nanoviricide aBacks the virus with hundreds of virus-‐binding sites on its surface. The nanoviricide is capable of dismantling the virus in the same way as strong soap solu9ons do, and the resul9ng complexes are fully biodegradable in the body.
Leveraging Breakthrough Biomime=c Nanotechnology to Create Powerful Novel Treatments Against Viruses Results in Strong In-‐Vivo Effec=veness in Animal Studies As an example, our preclinical studies with FluCide™ have shown substan9ally superior survival and viral load reduc9on results versus the standard-‐of-‐care, treatment. For both H1N1 and H3N2. FluCide is expected to be effec9ve against most, if not all, strains of influenza A, even novel strains that can cause epidemics.
Our preclinical studies with HerpeCide have recently shown remarkable 85% to 100% survival of lethally infected animals in repeated studies in a skin infec9on model. We are now op9mizing the HerpeCide drug candidate to define poten9al clinical leads.
Strong Safety Established in Mul=ple Animal Studies and Mul=ple Animal Species Injectable FluCide was found to be well tolerated in mice even at maximum feasible dosage levels in a non-‐GLP safety/toxicology study. Thereaqer, a non-‐GLP tox study in rats found that a related drug candidate was also safe at as much as a total of 4,200mg/kg
Page � of �2 4
NOVEL BIOMIMETIC NANOVIRICIDE TECHNOLOGY ADDRESSING UNMET MEDICAL NEEDS
LARGE MARKETS. SAFE and HIGHLY EFFECTIVE TREATMENTS. SCALABLE MANUFACTURING.
100% Survival on FluCide Treatment
100% Dead at 8 days on Oseltamivir Treatment
100% Dead at 5 days with No Treatment
Viral Load Reduction: 1,000X on FluCide,
only 2X on Oseltamivir
Complete Survival on FluCide Treatment with > 1,000-fold Viral Load Reduction after lethal Influenza Infection .
Disease/Virus $Billions
HIV/AIDS $ 25 B
Influenzas $ 10 B
Eye Drops Antiviral $ 1~5 B
Herpes “Cold Sores” Skin Cream & Gel $ 2˜5 B
Hepatitis C $ 5˜10 B
Dengue, Rabies, other NTD’s $ 1˜5 B
Ebola/Marburg/VHF $ 1 B
given in 14 days. This study was completed at BASi Toxicology Services, IN, a CRO. In all animal studies and in all of our programs conducted since the beginning, no evidence of toxicity has been found even at very high dosage levels.
Safety is built into the nanoviricide’s structure. The polymer is based on PEG in the backbone and faBy chains forming the “belly” of the nanoviricide. PEG is well known and is used in virtually all an9body drugs as well as many nanomedicines to protect the drug from aBack by the body’s re9culoendothelial system (RES). We design the ligands as well to avoid toxicity issues.
Effec=veness in Human Clinical Trials is An=cipated, based on Effec=veness in Animal Studies because a nanoviricide works directly against the virus par9cle in circula9on or outside cells, and not on host targets. A nanoviricide works independently of the host.
Strong Global Intellectual Property Posi=on with First Drug Patents to Expire Beyond 2036 NanoViricides has exclusive worldwide licenses to field-‐defining, pioneering, global patent applica9ons, that have already issued into 61 patents in countries including the U.S., Australia, Japan, China, Canada, and all of Africa. Issued patents are “first-‐in-‐class” with no prior art, showcasing the Company’s leadership posi9on in this field. The patents cover broad composi9ons of maBer, methods of making, and uses. The first of the fundamental patents has expira9on date in 2026. We also intend to patent each of our drug candidates separately. The first of our individual drug patents would not expire before 2036. This provides substan9al runway for commercial realiza9on.
As of December 31, 2015, the Company had approximately $28 million in cash and equivalents (unaudited, es9mated numbers), which management believes is sufficient to fund ini9al clinical trials for the first two of its leading drug candidates. In addi9on, the Company has approximately $12 million in fixed assets net of deprecia9on. The Company currently spends only approximately $1.7 million per quarter. The expenditure rate is expected to increase as we move closer to IND filings, and then into clinical trials. Long term debt stands at about $11 million and is conver9ble into common stock.
Eight Drugs in Our Broad Pipeline Injectable FluCide for Hospitalized Pa9ents is our most advanced drug candidate, and is in Tox Package and other IND-‐enabling studies. Scale-‐up and characteriza9on studies are in progress.
Our HerpeCide™ program has matured towards mul9ple drug indica9ons, namely (a) an9-‐HSV skin cream to treat oral “cold sores” (primarily HSV-‐1), (b) Eye Drops to treat ocular Herpes Kera99s, (c) skin cream to treat genital lesions (primarily HSV-‐2), and (d) an9-‐VZV skin cream to treat Shingles outbreak. We are in the final stages of op9mizing these drug candidates to define clinical leads. In addi9on, we are developing an9-‐HIV and an9-‐Dengue virus drugs. We have also developed an orally available nanoviricide drug to treat influenza.
Thus to date, NanoViricides has developed eight drug candidates. We also have research programs for Ebola, Rabies, MERS, and other viruses.
Complex Nanomachine R&D to a`ack virus only everywhere sparing host All our current nanoviricides work primarily on the virus in circula9on. However, the targeted nanoviricide technology can be harnessed to aBack only virus-‐infected cells, sparing normal cells, because the infected cells present viral an9gens to which nanoviricides can bind. The nanoviricide technology has the ability to encapsulate (hold) ac9ve ingredients that could kill or disrupt virus produc9on inside infected cells only. Our leading R&D in this field should lead to the best ever an9viral medicines in the future.
“Accurate Drug In Field™” (ADIF™) Our ADIF technology is designed to avoid epidemics such as the recent Ebola from happening all together. A drug against a novel pathogen can be developed directly in the field, or selected from our library, only using simple tests, with no need to study the pathogen in detail. We intend to develop this program further when financing is available.
Page � of �3 4
GLOBAL, STRONG, PIONEERING INTELLECTUAL PROPERTY POSITION WITH RUNWAY BEYOND 2036
STRONG FINANCIAL POSITION -‐ SUFFICIENT CASH FOR INITIAL CLINICAL TRIALS
BROAD AND DEEP NANOVIRICIDES PRODUCT PIPELINE
Slide © All Rights Reserved, NanoViricides, Inc., A Publicly Traded Company (NYSE-mkt: NNVC)
X
Broad Drug Pipeline Advancing Rapidly...
One Drug for All Influenzas
Conjunctivitis/Keratitis
Skin Cream & Gel - Oral, Genital Herpes
HIVCide™ “Functional Cure”?
DengueCide™ Avoid ADE Effect
Current Mkt Size > $8B $1B-$5B >$2B >$22B >$1B
Injectable: $1B est, if effective drug
market will expand if effective drug
market will expand if effective drug
market size should decrease as HIV is
controlled
Est > $10B global if effective drug
Oral: to >$20B est, for effective drug
HSV-1 linked to Alzheimer’s Disease
however, market will increase until
cure
Orphan Drug Benefits in US and EU
1. HSV Cold Sores
2. HSV Herpes Keratitis
3. VZV Shingles
4. HSV Genital Lesions
FluCide™5. Injectable
6. ORAL 7. DengueCide™
Avoid ADE8. HivCide™
“Functional Cure?”
For Hospitalized & Out
Patients
Dermal Topical Lotion
Eye Drops
Dermal Topical Cream
Genital Lesions Topical Cream
West Nile Virus, Yellow Fever Virus,
Jap. EncephalitisHIV
HSV Drugs
Franchise in
Development
Post-Discovery...
Hepatitis C
RabiesMERS
Coronovirus
Many More to Do
Page � of �4 4
2015 GOALS ACCOMPLISHED
Eugene Seymour, MD, MPH, Chief Execu=ve Officer – Working in the HIV field since the very first AIDS cohort was iden9fied in Los Angeles. NNVC is his 2nd public company, aqer Stat-‐Sure, Inc.
Anil R. Diwan, PhD, President and Chairman – Invented and developed novel nanomedicine technologies. PhD from Rice University and a B.Tech from IIT Bombay. 20+ years experience running entrepreneurial businesses and R&D.
Meeta R. Vyas, SB, MBA, CFO – Former CEO of Signature Brands, a public company she turned around, was acquired by Sunbeam Corp; ex GM of GE Appliances Range products with sales over $1 Billion, she doubled opera9ng income; ex Principal with Gores Opera9ons Group, a PE firm based in Los Angeles.
Randall W. Barton, PhD, Chief Scien=fic Officer – Ex-‐Director of In-‐Vivo Cardiovascular Research at Boehringer-‐Ingelheim. An expert in receptor-‐based drug design. More than 60 scien9fic publica9ons, 5 patents and 3 patent applica9ons.
Jayant Tatake, PhD, Vice President of R&D – Co-‐inventor of the Company’s nanomedicine technologies. Over 23 years experience with produc9on of pharmaceu9cals from lab scale through cGMP manufacture. PhD from UICT-‐Bombay.
HIGHLY EFFECTIVE MANAGEMENT TEAM STRONG INDEPENDENT BOARD OF DIRECTORS
Milton Boniuk, MD -‐ Caroline F. Elles Chair Professor of Ophthalmology at Baylor College of Medicine, TX. Successful entrepreneur. Established the Boniuk Ins9tute for the Study and Advancement of Religious Tolerance at Rice University. Investor and long term supporter of NanoViricides, Inc. Stanley Glick, CPA -‐ Chairman of the Audit CommiBee. Experienced prac9cing finance, accoun9ng and tax professional.
Mukund Kulkarni, MBA, PhD – Chancellor of Penn State University, Harrisburg, PA. Professor of Finance. Accomplished administrator, scholar, and teacher.
In addi9on, the execu9ves Eugene Seymour, and Anil Diwan are elected members of the Board and serve on the Execu9ve Team.
In FY 2015, and through December end 2015, we moved all opera9ons to the new facility in Shelton, CT, in a phased manner, over a period of several months. We have added several key members to our staff both at NanoViricides and at our associates, with the combined strength of more than 30 as of now. We have engaged in significant training exercises for the new members of our team as well as for the overall team. Also, we developed manufacturing control and quality analysis methods for our polymer manufacturing processes at approximately 500g scale. In addi9on, we are con9nuing the non-‐GLP tox package studies for FluCide. We are con9nuing to work on FluCide scale-‐up to kilogram scale, quan99es required for our tox package studies, because of the strong safety. Most importantly, we have achieved substan9al successes in our HerpeCide project, demonstra9ng complete survival of lethally infected animals in a special skin infec9on model. This has transformed the HerpeCide project into a mul9-‐drug franchise. We are developing (a) an9-‐HSV skin cream for control of oral “cold sores”, (b) an9-‐HSV skin cream for healing genital herpe9c lesions, (c) Eye Drops to treat Herpes Kera99s, and (d) an9-‐VZV skin cream to treat Shingles outbreak, under this project. We are now in the final stages of op9miza9on of drug candidates in these programs. All of the Herpes program drug candidates are expected to require substan9ally smaller drug quan99es for their tox package studies as well as for clinical trials. These programs are therefore an9cipated to develop more rapidly than the FluCide programs.
2016 GOALS ANTICIPATEDWe intend to advance the mul9ple drug candidates in the HerpeCide programs further. We an9cipate we will need rela9vely small quan99es of the HerpeCide program drug candidates for Tox Package studies, because of their topical nature. We will need to develop standard opera9ng procedures, implement quality assurance and quality control systems. We are therefore developing most of our processes at about 500g scale at present. We are developing several collabora9ons and contract rela9onships for the study of these Herpes and VZV drug candidates in suitable animal models to complete the candidate op9miza9ons and thereaqer to characterize declared clinical candidates in IND-‐enabling studies. We an9cipate being able to declare Herpes and VZV program clinical drug candidates in the ensuing year. In contrast, we need to produce mul9-‐kilogram quan99es of FluCide for GLP Tox Package studies. We intend to advance the FluCide scale-‐up process development further. We also need to perform substan9al addi9onal efficacy studies against different influenza virus subtypes, as needed for the IND filing. Other drug programs will con9nue at lower priori9es. Note: The ac9vi9es described have a strong dependence on factors outside the Company’s control. Also, the Company does not have all the personnel or facili9es needed for conduc9ng these projects. Hiring, training, purchasing and bringing into opera9on new equipment, reactors, controllers, se{ng up data acquisi9on systems, seeing up quality control and assurance systems, etc. may cause significant delays. In addi9on, the program costs may be substan9ally greater than the Company an9cipates. The Company may adjust its priori9es due to such constraints resul9ng in delays in accomplishments.
Disclosure Statement NanoViricides, Inc. (“the Company”) is a publicly traded company (NYSE MKT stock symbol: NNVC.) This fact sheet not an offering memorandum and should not be construed as such. It is provided as a non-‐confiden9al document for informa9onal purposes only. NanoViricides, Inc.(www.nanoviricides.com) is a development stage company that is crea9ng special purpose nanomaterials for an9-‐viral therapeu9cs. The Company's novel nanoviricide® class of drug candidates are designed to specifically aBack enveloped virus par9cles and to dismantle them. This document contains forward-‐looking statements that reflect the current expecta9on of the Company regarding future events. Actual events could differ materially and substan9ally from those projected herein and depend on a number of factors. Certain statements are “forward-‐looking statements” within the meaning of Sec9on 27A of the Securi9es Act of 1933 and Sec9on 21E of the Securi9es Exchange Act of 1934. You should not place undue reliance on forward-‐looking statements since they involve known and unknown risks, uncertain9es and other factors that are, in some cases, beyond the Company's control and that would materially affect actual performance or achievements. The Company assumes no obliga9on to publicly update or revise these forward-‐looking statements for any reason, or to update the reasons actual results could differ materially from those an9cipated, even if new informa9on becomes available in the future. Important factors that could cause actual results to differ materially from the company's expecta9ons include, but are not limited to, factors that are disclosed under the heading "Risk Factors" and elsewhere in documents filed by the Company from 9me to 9me with the U.S. Securi9es and Exchange Commission and other regulatory authori9es. Although it is not possible to predict or iden9fy all such factors, they may include the following: demonstra9on and proof-‐of-‐principle in preclinical trials that a nanoviricide is safe and effec9ve; successful development of our product candidates; our ability to raise addi9onal financing when needed; our ability to seek and obtain regulatory approvals, including with respect to the indica9ons we are seeking; the successful commercializa9on of our product candidates; and market acceptance of our products.
Contact
Investors Dr. Eugene Seymour, [email protected]
General: [email protected]
Strategic Dr. Anil R. Diwan, [email protected]
Website: www.nanoviricides.com
Business Development
Dr. Randall W. Barton, [email protected]
Address: 1 Controls Drive, Shelton, CT 06484.