May 23, 2013

A human cell line that produces a

human antibody that neutralizes HIV

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A human cell line that produces a human antibody that neutralizes HIV

BioClonetics has created a human cell line that produces a human antibody (designated as CLONE 3) that neutralizes HIV, the virus that causes AIDS.

As its primary mission, the Company is preparing for animal and human trials to ready its antibody for use in treating those with HIV/AIDS and for production of an AIDS vaccine.

Source: BioClonetics Immunotherapeutics,

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Population GroupTotal Number

Infected1

Annual Infection Rate1

Annual Death Rate1

World 33 Million 2.7 Million 2 Million

Major Markets1 10.4 Million 720,000 556,000

North America and Western Europe

2.3 Million 155,000 111,000

Children (World wide) 3.1 Million 430,000 290,000

China 740,000 48,000 25,000

U.S. 1,700,000 56,000 18,000

The PROBLEM of the HIV/AIDS Pandemic

Source: (1) UNAIDS, World Health Organization; Avert.org; Center for Disease Control; Univ. Calif. San Francisco Medical Center; UNIAIDS China, 2009; Major markets include the countries North American, Western and Central Europe, Eastern Europe and Central Asia, South and Southeast Asia and Latin America.

The PROBLEM:Comparison of HIV and Cancer Affliction

Source: Estimates of UNAIDS; World Health Organization (WHO) 2009

Annual Occurrences of HIVIn children are greater than cancer

SubjectsHIV

Annual CancerAnnual

Children afflicted 430,000 160,000

Children who die 290,000 90,000

Individuals afflicted 3.1 Million 11 Million

Individuals who die 2.1 Million 7.4 Million

TOTAL Afflicted 33 Million 25 Million

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The PROBLEM: Current chemotherapeutic ARVs are

unsafe, ineffective and expensive

No satisfactory or safe treatment is available; chemotherapeutic anti-retroviral (ARV) drugs are:• Highly toxic

• Cause liver and kidney failure,

• Cause increased cardiovascular disease (4 times as likely)

• Decrease bone density

• Cause severe vitamin deficiency

• Must be administered for life and do not provide a cure

• Create treatment resistant strains of the virus that cannot be treated and are fatal

ARV Treatment is expensive

• Current average annual costs (U.S.) per patient is $10,000 (drugs only)

• Life-time costs (U.S.) per patient (over an average treatment span of 24 years) is $240,000

Source: BioClonetics Immunotherapeutics,

Clone 3 provides a uncompromised SOLUTION

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BioClonetics has produced a human monoclonal antibody, Clone 3, which neutralizes HIV

The antibody binds to a highly conserved four amino acid sequence KLIC (epitope) on the viral surface transmembrane outer protein envelope and kills the virus

Use of monoclonal antibodies against HIV is widely recognized as a promising approach to achieving effective therapy: NIH announcement May 2008: “New research program focused on generating broadly neutralizing antibodies”.

Source: BioClonetics Immunotherapeutics

HIV gp41 viral stalk

Clone 3

Technical Summary and Status

How Does Clone 3 Work?

For HIV to infect, it requires binding between the virus and the human CD4 cell at two target sites (a primary and secondary).

The Clone 3 interrupts the second binding site of the virus to the human CD4 cell and prevents infection by fusion.

Immunotherapy is safe and effective.

Administered in a finite period (12 months) rather than requiring life long use, as is the case with anti-retroviral therapies now used to treat HIV/AIDS.

The antibody is ready for testing in primates but must first be produced in the recombinant form for such tests and for human trials.

7Source: BioClonetics Immunotherapeutics

Proof of EFFICACY – First 3rd Party Evidence

The Clone 3 human antibody neutralized HIV in all clades and groups found around the globe. It has been tested at 5 research institutions against 45 strains of the virus:

1. University of California, San Francisco, CA, USA (Jay Levy, MD)

2. University of South Florida, Tampa, FL, USA (Kenneth Ugen, PhD)

3. Polymun Scientific, GmbH, Vienna, AUSTRIA, (Hermann Katinger, PhD)

4. Duke University, Durham, NC, USA (David Montefiori, PhD)

5. Dana Farber Cancer Institute, Harvard Medical School, Boston, MA, USA, (Ruth Ruprecht, MD, PhD)

8Source: BioClonetics Immunotherapeutics

Proof of EFFICACY – 3rd Party Evidence

• Test in five (5) international research institutes have shown that Clone 3 antibody neutralizes (at IC90*) 41 of 45 (over 91%) of primary HIV isolates tested, from clades A, B, C, E, and F from around the globe. Clade C is the clade prevalent in China.

• By comparison, the clinical use of approved viral fusion-inhibitor Fuzeon, shows the post-therapy viral burden to be less than 50 copies of HIV in only an average of 33% of patients, and is known to be highly toxic and cannot eradicate the virus.

Independent Laboratory Test Results

Source: BioClonetics * IC90 - Inhibitory Concentration of Clone 3 mAb (<30 microgram/ml) that neutralizes 90% of HIV virions

Clades

Percent infections responding completely to Fuzeon treatment: average only 33%

Per

cen

t N

eutr

aliz

atio

n

Clone 3 mAb neutralized 91% (41/45) of all HIV clades tested

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Proof of EFFICACY – 3rd Party Evidence

Clone 3 target site exists in 98% of all viral strains (clades and groups) of HIV around the globe and thus, Clone 3 can be broadly effective

Source: Los Alamos National Laboratories HIV Sequence Database; October 2010

The HIV target site data neutralized by Clone 3

2,229 HIV viruses identified in 60 countries representing all clinically-identified viruses

available to the National Laboratory at Los Alamos HIV viral sequence database repository

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Clone 3 human antibody’s global geographic effectiveness including effectiveness against Clade B which is prevalent in North America

Source: BioClonetics Incorporated, Independent In Vivo Research Institute Studies, IAVI June 2009

Clone 3 Antibody is effective everywhere and has global application on all continents

(effective against all Clades)

Clone 3 Antibody is effective everywhere and has global application on all continents

(effective against all Clades)

HIV virus map by subtype (Clades)HIV virus map by subtype (Clades)

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International Studies Human Clinical Correlate TEST Results

A. P.A. Broliden et al. Infants who lacked anti-KLIC (Clone 3) antibodies had a rapid progression to symptomatic AIDS

B. Vanini et al. Decreasing concentration of anti-KLIC (Clone 3) antibodies directly correlated with HIV disease progression

C. Loomis-Price et al., High antibody reactivity to the peptide containing the immunogen epitope [KLIC] (Clone 3) is associated with slow progression to AIDS

D. Dietrich et al. Long-Term Non-Progressors (LTNPs) are individuals with the virus but having normal T‑cell counts, no opportunistic infections without ARVs) show the presence of anti-KLIC antibodies

E. Cano et al. Correlation between the presence of anti-linear peptide antibodies and the patient’s ability to endure the infection.

F. NIH conducted primate vaccine studies

Successfully vaccinated Rhesus macaque primates with a homologous immunogen that produces the Clone 3 neutralizing protective antibody

Proof of EFFICACY – More 3rd Party Evidence

The Company’s immunotherapeutic technologyprovides for a Therapy and Vaccine

• (A) Immunotherapy for those individuals who are HIV-infected

• (B) A prophylactic vaccine to prevent contraction of the virus. An effective immunogen, a vaccine, can be produced from the KLIC immunogen binding site on the virus.

Clone 3 Antibody

Clone 3 Antibody binds to gp41 viral stalk of HIV-1

(B) Clone 3 Active Vaccine

Immunizationfor all 6.7 billion un-infected

individuals

(A) Clone 3 Antibody Passive Immunotherapy

for all estimated 33 million HIV+ patients

Clone 3 Immunotherapeutic Technology Products

(B)(A)

HIV-1

Products

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RecombinantAntibody

Source: BioClonetics Immunotherapeutics

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2014 2014

Q1 Q2 Q3 Q4

Milestone 1: Production ofRecombinant Human Antibody; an FDA requirement for Primate Pre-clinical and Human Clinical Trials

Milestone 2: Primate Pre-clinical trials (Keeling Center for Comparative Medicine & Research – San Antonio, Texas USA or Zerun)

Proposed Recombinant Clone 3 Production and Animal Trials/FDA-EMEA IND Phase 1 meeting for Human Clinical Trial Study

Milestone 3: FDA-EMEA IND Phase I meetings for human clinical trial study initiation for Clone 3 passive immunotherapy and vaccine

Source: BioClonetics Immunotherapeutics

mAb Passive Immunotherapy

Commercial Recombinant

Antibody

Marketing and Sales Strategy:Clone 3 Patent Protection

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First Company Patent

Vaccine

mAb Passive Immunotherapy

RecombinantAntibody

Pending Patent Protection - (1) Recombinant Antibody Production(2) Active Peptide Vaccine

Source: BioClonetics Immunotherapeutics

ParentAntibody

A

B

Business Model:Who are the HIV/AIDS market-space players?

• Annual worldwide HIV/AIDS chemotherapeutic drug sales in 2008 were $10.7 Billion USD

- Annual sales are expected to climb to $15.1 Billion by 2017

- U.S. and European markets accounts for 60% of the gross annual revenues

• Marketed anti-retroviral (ARV) therapies

- NRTIs – Combivir by GlaxoSmithKline

- NNRTIs – Viramune by Boehringer

- PIs – Kaletra by Abbott

- FI – Fuzeon by Roche-Trimeris

Source: Datamonitor 2010, Cambridge Healthtech Institute

HIV/AIDS Chemotherapeutic Drug Revenues and Market Share

HIV Antiretroviral Market Share

Roche

Gilead

GlaxoSmithKline

generic drugs

Boehringer IngelheimGilead

Abbott

Bristol Myers Squibb

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BioClonetics Immunotherapeutics Company Team Members

• Joseph Cotropia, MD–CSO and Founder–Physician (Internal Medicine),

Immunobiochemist–37 Years as a physician in private

practice, immunology research and discovery at BioClonetics

–FDA Fellow Research Scientist, senior reviewer of INDs at Center for Biologic Evaluation and Review (CBER)

–College Station, TX

• Charles Cotropia, JD–Vice-President/Counsel–39 years as an intellectual property

attorney–Dallas, TX

Source: BioClonetics Immunotherapeutics 17

• Tomasz Zastawny, DSc, PhD–Director Laboratory Operations–20 Years of expertise in Clinical Trials

Operations and Studies–Clinical Studies Operations Director for

Pro-pharmaceuticals–Senior Advising Consultant to large

pharmaceutical sector industry

• Paul D. Fellegy– Director Business Operations–25 Years of expertise in financial

services consulting, operations and management

–Senior consultant to Fidelity Investments, John Hancock, Putnam Investments, and State Street Global Advisors

• Tzvete Dentchev, MD–Director of Clinical Research–Senior Molecular Research Scientist

with 35 years of expertise –University of Pennsylvania (UPENN), PA

BioClonetics ImmunotherapeuticsScientific Advisory Team

• Dimiter Dentchev, MD, PhD–Chief, Clinical Pathology–Thomas Jefferson Hospital,

Philadelphia, PA–30 Years of Clinical Pathology Studies–BioClonetics Scientific Advisor

• Dalila M. Corry, MD–Professor of Clinical and General

Medicine–Chief, Division of Nephrology–University of California Los Angeles

(UCLA)–35 Years of human clinical trial studies–10 Years of HIV clinical trial studies

relating to HIV+ nephrology patients–David Geffen School of Medicine–BioClonetics Scientific Advisor

• Ellen S. Vitetta, PhD–Professor and Director, Cancer

Immunology Center, UT Southwestern Medical School Dallas, TX

–The Scheryle Simmons Patigian Distinguished Chair in Cancer Immunobiology

–Professor of Microbiology–35 Years of expertise in active vaccine

design and human clinical trial studies–BioClonetics Scientific Advisor

• Yvonne J. Bryson, MD–Professor of Pediatrics–Chief, Division of Pediatrics Infectious

Disease–University of California Los Angeles

(UCLA)–35 Years of pediatric clinical trial studies

in HIV/AIDS–David Geffen School of Medicine–BioClonetics Scientific Advisor

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Source: BioClonetics Immunotherapeutics 19

BioClonetics ImmunotherapeuticsCollaborations

Name of Institution Institute or Department

Primary Contact Nature of Relationship

University of TexasSouthwestern Graduate Schoolof Biomedical SciencesDallas, TX

Center for Cancer Immunobiology

Ellen S. Vitetta, PhDDirector

Collaborative research and active peptide

vaccine design;Oral medications

formulation design

University of TexasMD Anderson Research CenterBastrop, TX

Michale E. Keeling Comparative Medicine and Research Center

Christian R. Abee, DVMDirector

Collaborative research and primate pre-clinical

Rhesus macaque neonatal studies

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Company Intellectual Property (IP)

Patent Number Owner Title

US Patent No. 6,083,504BioClonetics Immunotherapeutics

Human Monoclonal Antibodies Directed Against the Transmembrane Glycoprotein (GP41) of Human Immunodeficiency Virus-1 (HIV)

Status Owner Title

Filed BioClonetics Anti-HIV Small Molecular Peptides

Patent Applications Pending FilingRecombinant Human Monoclonal Antibodies Directed Against the Transmembrane Glycoprotein (GP41) of Human Immunodeficiency Virus-1 (HIV)

Sub-unit Vaccine against Human Immunodeficiency Virus-1 (HIV)

Patent Issued

Patent pending

Patent Applications Pending Filing

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CompanyIntellectual Property (IP)

Description

Clone 3 parent cell line is proprietary

Methodology and process for creating immortalized cells that produce stable human neutralizing monoclonal human antibodies are trade secrets

Proprietary IP

Company Near Term Objectives

• What the company will achieve in 12-18 months

1. Preparation of the commercial recombinant Clone 3 anti-HIV monoclonal antibody

2. Test the recombinant antibody in Rhesus macaques primates

3. Begin human trials

• What the company will achieve in 36 months

1. Prepare anti-HIV Vaccine based on Clone 3 anti-HIV monoclonal antibody

2. Pre-clinical studies and human studies leading to market application of an anti-HIV vaccine

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Clone 3 Antibody-based Immunotherapeutic Technologies Platform

SUMMARY

• Large unmet medical need

–ARV drugs can not eradicate virus from HIV-infected patients, nor provide a cure

–ARV drugs are not sufficiently effective, safe or protective

• Clone 3 antibody therapy will be safer, more effective and less expensive

–The technology provides a highly profitable, disruptive therapy that can supplant current ARV treatments now used by HIV patients

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