Corporate Overview OTC QB: SVON OCTOBER 7, 2014 Safe Harbor - - PowerPoint PPT Presentation

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Corporate Overview OTC QB: SVON OCTOBER 7, 2014 Safe Harbor - - PowerPoint PPT Presentation

Corporate Overview OTC QB: SVON OCTOBER 7, 2014 Safe Harbor Statement Certain statements included in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Actual results


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OTC QB: SVON

Corporate Overview

OCTOBER 7, 2014

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Certain statements included in this press release are forward-looking statements within the meaning

  • f the Private Securities Litigation Reform Act of 1995. Actual results could differ materially from such

statements expressed or implied herein as a result of a variety of factors, including, but not limited to: the Company’s ability to integrate the Fabrus science and operations; the Company’s ability to continue as a going concern; the Company’s ability to recruit patients for its clinical trial; the ability of the Company to consummate additional financings; the development of the Company’s gene and antibody technology; the approval of the Company’s patent applications; the current uncertainty in the patent landscape surrounding small inhibitory RNA and the Company’s ability to successfully defend its intellectual property

  • r obtain the necessary licenses at a cost acceptable to the Company, if at all; the successful implementation of

the Company’s research and development programs and collaborations; the success of the Company's license agreements; the acceptance by the market of the Company’s products; the timing and success of the Company’s preliminary studies, preclinical research and clinical trials; competition and the timing of projects and trends in future operating performance; and the quotation of the Company’s common stock on an over- the-counter securities market, as well as other factors expressed from time to time in the Company’s periodic filings with the Securities and Exchange Commission (the "SEC"). As a result, this press release should be read in conjunction with the Company’s periodic filings with the SEC. The forward-looking statements contained herein are made only as of the date of this press release, and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Safe Harbor Statement

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Clinical stage oncology and immunology company focused on the discovery, development and acquisition

  • f innovative products

Proprietary technology platforms

– Cow antibody scaffold allows drugging of previously

inaccessible targets

– Arrayed Antibody discovery technology enables

differentiated screening

– eIF5A gene technology broadly regulates cell death

and survival

Platform validated by multiple first-in-class drug candidates and drug discovery collaborations with large pharma 108 issued patents (31 U.S., 77 foreign) with multiple pending applications Company leadership with a proven track record New corporate identity (formerly Senesco/Fabrus)

About Sevion Therapeutics

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Multiple First-in-Class Therapeutics in Development

Discovery Preclinical Phase 1 Phase 2 Phase 3

SNS01-T

(nanoparticle; eIF5A )

SVN-001

(Cow Antibody, Kv1.3)

SVN-002

(Human Antibody)

SVN-003

(Chimerasome; insulin receptor)

Other Internal Targets

(Antibodies; GPCRs, ion channels)

Undisclosed* Undisclosed*

* Collaboration: Sevion activities expected to begin Q4 2014 Oncology – MM, DLCBL Autoimmune/Inflammation Oncology - RCC Oncology - RCC Oncology Oncology Oncology

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Only a small fraction of potential targets are effectively addressed with current antibody technology (hybridoma, display)

Sevion Therapeutics: Addressing the Problem with Current Antibodies

Current Technology Soluble Proteins Sevion Technology Membrane Proteins Sevion employs two approaches to drugging novel targets Cow antibodies Arrayed libraries

(i.e. TNFa)

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Unique ultra long structure enables binding to otherwise intractable targets (such as crevices, pores, channels,

  • r other targets that “regular”

antibodies cannot) Humanization of the cow scaffold enables therapeutic use Novel intellectual property on composition of cow antibodies and humanization (in-licensed from Scripps and internal)

Novel Cow Antibody Platform

Ultra long CDR3 antibodies are unique to cows

Wang et.al. (2013) Cell 153: 1379-1393

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Fundamentally differentiated from phage display and hybridoma technologies

IgG format - manufacturing Cell surface screening Faster, more relevant hits Unique activities

Arrayed Antibody Discovery: Small Molecule Paradigm Applied to Antibodies

DNA – human genome project

Tens of thousands of antibodies

High-throughput, parallel protein production High-throughput gene synthesis

Bioinformatics

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High throughput cell sorting (FACS) allows us to rapidly screen multiple targets simultaneously directly on the cell

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Proprietary Cell Surface Antibody Discovery

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Proprietary enabling platform for internal pipeline development, lead discovery for out-licensing, and drug discovery collaborations

Pharma validation: BMS - discovery

  • f antibodies against two GPCR targets

in oncology Additional collaborations pending

Validated Platform

Generated antibodies to over 25 targets Antagonist and modulator antibodies discovered and engineered against GPCR targets Unique antibodies/epitopes against common targets like Her2, and ErbB3 identified Novel cow scaffold engineered and validated against an ion channel (Kv1.3) with pM range activity

Composition of matter and use patent claims on SVN001 and SVN002

Antibody Discovery Leveraged for Internal Portfolio and Collaborations

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Kv1.3 is a novel ion channel critical for T-cell activation

Plays critical role in modulating activity of effector memory T-cells (TEM) T-cell activation plays a role in autoimmune disease: arthritis, psoriasis, IBD, GVHD, MS and others Scorpion venom treatment effect on MS (Lancet 2:1021 (1983)) later shown to be due to blockade of the Kv1.3 ion channel

Sevion has developed a novel cow antibody with the efficacy attributes of venom but with half-life, stability, and dosing attributes

  • f an antibody

SVN001: First in Class Kv1.3 Antibody for Autoimmune Diseases

Venom/bioactive peptide

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Safety – Intact Immune System: Selective against TEM cells, T-cell compartment remains intact, leaving the immune system capable of fighting infections. Limitations of current therapies are related to AE’s due to broad immunosuppression Ultra Potent: pM IC50’s in human blood and T-cell activation assays Half-Life: IgG Fc region affords long t1/2 (potential once a month SQ dosing) Medical Need: More than a third of patients across all indications are non-responsive to anti-TNF treatments Novel MOA/Reversible: Inhibiting the Kv1.3 target suppresses multiple key inflammatory

  • cytokines. Anti-Kv1.3 inhibition is effective after

T-cell activation and is reversible

Why SVN001 Will Have High Impact

Inhibition of T-cell activation by a humanized cow antibody

TNFa (A450, sem) 0.15 0.3 0.45 0.6 0.001 0.01 1 10 100 1000 ec50=0.2nM (nM)

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(currently undisclosed) which is highly expressed in Clear Cell Renal Carcinoma. Target is associated with blood vessel sprouting/angiogenesis, independent

  • f VEGF and is associated with poor

prognosis in ccRCC May solve anti-VEGF resistance, which

  • ccurs in all ccRCC metastatic patients

SVN002: Unique Target for Renal Cell Carcinoma

SVN002 binds to a target

Colored urogram (X-ray) of the left kidney of a patient with renal clear cell carcinoma (blue). Credit: Sovereign, ISM/Science Photo Library

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SVN002: Target Inhibition Reduces Growth as a Single Agent in a ccRCC Xenograft Model

Preclinical studies for this program are support by collaborations with University of North Carolina Cancer Center 600” 500” 400” 300” 200” 100” 0” 5 10 15 20 25 30 35

Treatment

PBS Antibody Days Tumor Volume (mm3) PBS Antibody

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Sevion Technology Expands Opportunity for MAbs Most Targets Cannot be Addressed by Current Modalities

GPCRs Pores/Pumps Ion Channels Posttranslational Modifications Multiprotein Complexes Non-Protein Targets

Carbohydrates Nucleic acids Sulfation Glycosylation

Our Target Market

Antibodies against membrane targets Novel approach to enable

Soluble Proteins Extracellular Domains

TNF VEGF EGFR Her2 CTLA4 IgE

Current Antibody Market

Hybridoma & display platforms Restricted to soluble and extracellular domains Inability to make purified antigen and immune restriction

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These two proteins act as a biological switch to promote cell death or survival

eIF5A Gene Regulation Platform: Targeting Cell Growth and Death: Broad Applications in Biotechnology

Lysine Hypusine eIF5A eIF5A

Amino Acid Amino Acid Call Death Survival Cancer Apoptosis

Targeted for cancer treatment (SNS01-T)

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First in class therapeutic with three components

siRNA to suppress pro-survival hypusine Proapoptotic plasmid expressing stable mutated eIF5A Polyethylenimine (PEI) forming nanoparticle for RNA/DNA

Only gene therapy/siRNA in Multiple Myeloma Phase I/II Study

Cohorts 1-3 completed, DLT reached in cohort 4 2/4 patients in Cohort 3 have SD after 6 weeks Most frequent AEs are infusion reactions and thrombocytopenia Results of Cohort 4 expected 2H 2014

Composition of matter and use patent claims

SNS01-T Gene Regulator Value Potential

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Experienced Management & Board of Directors

Ronald A. Martell

CEO, Sevion

Vaughn Smider, M.D., Ph.D.

CSO, Sevion

Harlan Waksal, M.D. (chair)

Founder, Imclone Systems

Philip Frost, M.D.

Chairman TEVA, CEO OPKO

Christopher Forbes

Vice President, Forbes Media, LLC

John Braca

Former partner SROne (Glaxo Smith-Kline)

David Rector

Principal David Stephen Group

Steven Rubin

COO, OPKO Health

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Financial Summary

Ticker: Stock Exchange: Recent Stock Price: 52 Week Range: SVON OTC QB $1.74 $1.28 - $6.35 Cash on Hand as of June 30, 2014 Cash Operating Expenses – June 30, 2014 Cash Operating Expenses – June 30, 2014 (Pro-Forma to Include Fabrus, Inc.) $6,100,000 $5,100,000 $8,100,000 Capitalization Table as of June 30, 2014 Common Equivalents Average Range Common Stock Outstanding 13,846,361 Preferred Stock (580 shares) 290,000 $2.00 Warrants 7,237,774 $4.77 $1.00 - $60.00 Options 979,304 $9.49 $2.65 - $140.00 Fully Diluted 22,353,439

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Advance two antibodies to the clinic in 18-24 months Evaluate Phase 1 data and determine development path for SNS01-T In-license new product candidates and synergistic technologies that are consistent with therapeutic area and/or scientific focus Establish robust pipeline of oncology/ immunology antibodies Secure additional drug development partnerships

  • n pipeline and technology platform

Strategy and Milestones

Become the preeminent, next-generation biologics company with best and first in class product candidates and technologies

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Phone: 908-864-4444 www.SevionTherapeutics.com OTCQB: SVON

SEVION TECHNOLOGIES, INC.

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