cytrx (cytr) corporate presentation · ovarian. 43%. 43%. renal . 0%. 7%. h&n. 10%. 20%. the...

Corporate Overview

June 2019

www.centurionbiopharma.com

Non-Confidential

The World’s Leading Company Targeting Albumin To Kill Solid Tumors

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Centurion BioPharmaHighlights Centurion BioPharma is a private subsidiary of CytRx focused on

transformational oncology drug development and diagnostics

We have completed the pre-clinical phase for our ultra high potency LADRTM drug candidates and accompanying companion diagnostic

Our four albumin binding drug candidates called LADRTM (linker activated drug release) have a unique albumin targeting and delivery mechanism that concentrates ultra high potency drugs inside the tumor, maximizing cell kill while minimizing systemic toxicity

The potential to combine our targeted platform with immunotherapy represents a significant advancement in oncology treatment


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Momentum has built for cytotoxins + immunotherapy in oncology Combining immunotherapy and cytotoxins is clearly becoming

the 'wave of the future' for the treatment of cancer – the most successful immunotherapy products are leading these cytotoxic combination breakthroughs –KEYTRUDA®, Merck & Co. Inc., Tecentriq, Genentech/Roche and Opdivo, Bristol Myers Squibb

Immunotherapy and cytotoxin combinations represent a significant opportunity for the Centurion pipeline as our unique platform can significantly improve how cytotoxin therapy performs with immunotherapy


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Immunotherapy and Cytotoxin Combinations Have Enormous Promise

Merck & Co. Inc, Keytruda. The Food and Drug Administration approved pembrolizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer.

Genentech/Roche: First positive Phase III study results for a cancer immunotherapy combination in breast cancer, with Tecentriq® plus nab-paclitaxel

Centurion’s ground-breaking innovation in cytotoxin therapy can improve efficacy even further with immunotherapy combinationsBristol Myers Squibb: Opdivo Plus Chemotherapy Showed Improved Progression-Free Survival Versus Chemotherapy in first-line advanced non-small cell lung cancer (NSCLC) with PD-L1 expression <1%, across squamous and non-squamous tumor histologies


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Vision and Development Strategies

Develop immunotherapy and LADRTM to work in combination in solid tumors

Concentrate ultra high potency drug inside the tumor, maximizing tumor cell kill and minimize toxicity

LADRTM has demonstrated broad utility across solid tumor types (lung, breast, ovarian, skin, head & neck)

Our companion diagnostic (ACDx) is personalized medicine to identify tumors eligible for treatment with LADRTM

LADRTM (linker activated drug release) maximizes full potential to target and kill the tumor while minimizing systemic toxicity

Build tumor-agnostic development plan

Easily train oncologists on the

technology

Establish treatment globally

Attain blockbuster revenue


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Centurion BioPharma Pipeline

LADR™ Albumin Binding Drug Conjugates

Preclinical Phase 1 Phase 2

Auristatin ProgramLADR-7: LADR-8:

Maytansinoid ProgramLADR-9:LADR-10:

Companion Diagnostic –ACDx (albumin companion dx) identifies patients across solid tumor types

Four albumin binding ultra high potency LADR™ candidates ready for IND enabling studies Companion diagnostic – identifies patients to treat


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LADRTM Platform Overview

2. Cleavable Linker• Novel linker keeps the

highly potent drug payload inactive until the conjugate reaches the tumor

• The linker is then cleaved which activates the payload

3. Targeting• Ensures rapid and

selective binding to circulating serum albumin

• Serum albumin transports the LADR™ drug to the tumor

1. Ultra High Potency Drug Payload

• Payloads are 10-1,000 times more potent than standard anti-cancer agents

• Similar to those used for ADCs (auristatins, maytansinoids)

Target albumin with ultra high potency drug in the tumor, minimize systemic toxicity

1 2 3


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Albumin as a Targeting Delivery Vehicle Albumin Major source of essential amino acids (“fuel″) for cancer cells Localizes at tumor through the Enhanced Permeability and

Retention Effect (EPR) effect and macropinocytosis Serves as a transport molecule for metabolites, hormones, and

nutrients Long half-life (20 days)


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LADR™ Mechanism of Action

Drug-linker conjugateis infused Tumor cells

Albumin transports drug to the tumor and

surrounding microenvironment

Linker dissolves in the acidic (low pH) environment and releases the drug payload

Rapid and specific binding to circulating albumin as the target

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2

3

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CytotoxicAgent Linker

CytotoxicAgent Linker

Albumin


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LADRTM Drug Payloads -Auristatins

• Semi-synthetic derivatives of natural product dola-10

• Monomethylauristatin E (MMAE) used inclinically approvedADC Adcetris®

for treatmentof refractoryHodgkin lymphomaDolabella auricularia (Sea Hare)

LADR-7,8 are auristatinsLADR-7,8 are auristatins


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LADRTM Drug Payloads -Maytansinoids

• Antimitotic agent by blocking polymerization of tubulin

• Derivative of maytansine (DM1) used inclinically approvedADC Kadcyla®

for treatmentof metastaticbreast cancer Maytenus serrata

(Ethiopian Shrub)

LADR-9, 10 are maytansines


(Roche/Genentech

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Summary: preclinical LADRTM data shows impressive efficacy Three poster presentations at AACR 2018

Robust anti-tumor activity in multiple tumor types

Durable responses averaged 60‒90 days

Demonstrated statistically significant superiority over the control group and parent compound

Highly effective even in large tumors with starting volumes of 270‒380 mm3


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LADR-7,8 preclinical efficacy by tumor type

Tumor type Response rate

CR PR

NSCLC 78% 22%

Melanoma 76% 10%

Ovarian 45% 46%

H&N 0% 70%

LADR-7(Auristatin E)

LADR-8 (Auristatin E)

CR PR

NCSLC 19% 5%

Melanoma 29% 21%

Ovarian 40% 0%

Renal 29% 14%

H&N 40% 40%The World’s Leading Company Targeting Albumin To Kill Solid Tumors

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LADR-9,10 preclinical efficacy by tumor type

LADR-9 (Maytansine)

LADR-10 (Maytansine)

Tumor Type Response RateCR PR

NCSLC 82% 12%Breast 6% 65%Ovarian 73% 9%Renal 14% 0%H&N 20% 60%

CR PRNCSLC 45% 24%Breast 0% 46%Ovarian 43% 43%Renal 0% 7%H&N 10% 20%


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LADRTM Targeting Tumorswith Albumin

Effective tumor targeting usingalbumin as a drug carrier

3. Improved tolerability allows for higher doses

2. Prolonged circulatory retention

1. Accumulation in tumor tissuedue to the EPR effect

(enhanced permeability and retention)


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Companion Diagnostic: ACDx (albumin companion dx)

ACDx is an imaging test that identifies albumin uptake in tumors. By determining if albumin is in the tumor, we can

determine if treating with LADRTM (an albumin binding drug conjugate) is appropriate. This is personalized medicine that is

highly valued by oncologists.

What is ACDx?

How is ACDxused?

Uses Single Photon Emission Computed Tomography (SPECT), commonly used by oncology practices throughout the world. ACDx and LADR will be products sold to oncology practices.

Goal When positively screened with ACDx, we believe patients will have a very high response rate when treated with LADRTM.


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ACDx will revolutionize the identification of solid tumors

OUR VISION: Personalized Medicine with Solid Tumor-Agnostic Treatment

Identify eligible patients for treatment

Improve outcome of clinical trials

Improve probability of breakthrough

status and approval

Rationale for payer

reimbursement

Justification for premium pricing

ACDx creates value when working as a companion diagnostic with LADRTM


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~40 min ~2 min

Preclinical SPECT/CT Imaging with 111In-C4-DTPAEstablish methodology in twohuman tumor xenograft models

Tumor type: LXFL 529 (NSCLC)Study outline: Bilateral implantation TV ~100‒300 mm3 (left and right flank)


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ACDx results in tumor-bearing nude miceRepresentative 3D SPECT/CT image after 72 h

Distinct accumulation of albumin in the tumors

Kidneys are visible as the organs ofelimination


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Centurion BioPharma Milestones

Event Completion Date

File one or more LADRTM patent applications Q4 2017

Initiate activities for GMP manufacturing of LADRTM linkers Q4 2017

Nominate one or more candidates for advancement into IND enabling studies Q1 2018

Present preclinical data on LADRTM candidates at AACR ‘18 1H 2018

Begin LADRTM pharma partnering discussions 1H 2018

File patent application for companion diagnostic 3Q 2018

Closing of a strategic transaction 2019

Strategic transaction will determine next steps on pre-IND meetings, studies and filing

Represents a completed milestone


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Summary Goal – a Centurion BioPharma major strategic transaction to be

closed in 2019

Our four albumin binding drug candidates called LADRTM (linker activated drug release) have a unique targeting and delivery mechanism that concentrates ultra high potency drug inside the tumor, maximizing tumor cell kill and minimizing systemic toxicity

Maximize full potential to target and kill the tumor, while minimizing systemic toxicity

Novel LADRTM technology platform has additional applicability with immunotherapy


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Leadership (Management)


Eric Curtis, CEO and PresidentMr. Curtis brings 25 years of life science leadership experience, specializing in oncology and orphan diseases. He was instrumental in the US and global development and commercialization of Votrient®, Doxil®, Velcade®, Benlysta®, Tykerb® and Adempas®.

Prior to joining Centurion, Mr. Curtis served in senior leadership roles as President and COO of CytRxCorporation, President, U.S. Commercial at Aegerion Pharmaceuticals, VP and GM – Rare Disease Business Unit at Bayer Healthcare, VP and global commercial leader at GlaxoSmithKline, and roles of increasing responsibility at Centocor/J&J.

John Caloz, Chief Financial OfficerMr. Caloz served as Chief Financial Officer of Occulogix, Inc, a NASDAQ listed, a medical therapy company, Chief Financial Officer of IRIS International Inc., a Chatsworth, CA based medical device manufacturer. He served as Chief Financial Officer of San Francisco-based Synarc, Inc., a medical imaging company, and SVP, Finance and Chief Financial Officer of Phoenix International Life Sciences Inc. Mr. Caloz, a Canadian citizen, is a licensed Chartered Accountant in Canada and a graduate of York University, in Toronto, Canada.

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Leadership (Management and Board)Steven Kriegsman, Executive ChairmanMr. Kriegsman has been Centurion BioPharma Corporation's Executive Chairman and a director since its formation. Mr. Kriegsman is an inactive Chairman and Founder of Kriegsman Capital Group LLC, a financial advisory firm specializing in the development of alternative sources of equity capital for emerging growth companies in the healthcare industry. He has advised such companies as SuperGen Inc., Closure Medical Corporation, Novoste Corporation, Advanced Tissue Sciences, and Maxim Pharmaceuticals.

Mr. Kriegsman also has a Family Office which manages his net worth.

Mr. Kriegsman has a BS degree with honors from New York University in Accounting and completed the Executive Program in Mergers and Acquisitions at New York University, The Management Institute. Mr. Kriegsman is a graduate of the Stanford Law School Directors' College. Mr Kriegsman was formerly a Certified Public Accountant with KPMG in New York City. He served as a Director and is the former Chairman of the Audit Committee of Bradley Pharmaceuticals, Inc. (NYSE, the company has since been sold). In February 2006, Mr. Kriegsman received the Corporate Philanthropist of the Year Award from the Greater Los Angeles Chapter of the ALS Association and in October 2006, he received the Lou Gehrig Memorial Corporate Award from the Muscular Dystrophy Association.Mr. Kriegsman has been a guest speaker and lecturer at various universities including California Institute of Technology (Caltech), Brown University and New York University. Mr. Kriegsman has been active in various charitable organizations including the Biotechnology Industry Organization, the ALS Association, the Los Angeles Venture Association, the Southern California Biomedical Council, the California Health Initiative, the American Association of Dance Companies, and the Palisades-Malibu YMCA.

Mr. Kriegsman served in the U.S. Army from 1963 to 1969.

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Board of Directors


Lou Ignaro, Ph.DDr. Ignarro received the Nobel Prize for Medicine in 1998. Dr. Ignarro received a B.S. in pharmacy from Columbia University and his Ph.D. in Pharmacology from the University of Minnesota. Dr. Ignarro is an esteemed medical researcher.

Dr. Ignarro serves as the Jerome J. Belzer, M.D. Professor Emeritus in the Department of Molecular and Medical Pharmacology at the UCLA School of Medicine. Retired in 2013, Dr. Ignarro had been at the UCLA School of Medicine since 1985 as a professor, acting chairman and assistant dean.

Earl W. Brien, MDDr. Brien is a renowned orthopedic and sarcoma surgeon who is a Professor of Orthopedic Surgery and also the Surgical Director of the Sarcoma Service at Cedars Sinai Medical Center in Los Angeles, California.

After completing his matriculation as a Fellow at Memorial Sloan Kettering Cancer Center and the Hospital for Special Surgery in musculoskeletal tumors and metabolic bone disease respectively, he became the Director of the Musculoskelatal Tumor Program and Metabolic Bone Disease Center at Orthopedic Hospital.

Joel CaldwellMr. Caldwell brings more than 30 years of experience in tax matters, finance, and internal auditing. He is a Certified Public Accountant. He retired from Southern California Edison, one of the nation’s largest public utilities, where he had been employed for 28 years in various executive-level accounting and finance positions covering Internal Audits, Executive Compensation, Long Term Finance, Employee Benefits and, most recently prior to his retirement, Sarbanes-Oxley Internal Controls Compliance. He also worked in public accounting at the firm of Arthur Andersen & Co.

cytrx (cytr) corporate presentation · ovarian. 43%. 43%. renal . 0%. 7%. h&n. 10%. 20%. the...

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