CytRx (CYTR) Corporate Presentation€¦ · december 2018 non-confidential . nasdaq: cytr. fighting...

Corporate OverviewDecember 2018

Non-Confidential

NASDAQ: CYTR

FIGHTING CANCER WITH CUTTING EDGE SCIENCE

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CytRx Safe Harbor StatementTHIS PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS THATINVOLVE CERTAIN RISKS AND UNCERTAINTIES. ACTUAL RESULTSCOULD DIFFER MATERIALLY FROM THOSE PROJECTED IN THE FORWARD-LOOKING STATEMENTS AS A RESULT OF THE RISK FACTORS DISCUSSEDIN CYTRX REPORTS ON FILE WITH THE U.S. SECURITIES AND EXCHANGECOMMISSION INCLUDING, BUT NOT LIMITED TO, THE REPORTS ONFORM 10-Q FOR THE QUARTER ENDED SEPTEMBER 30, 2018.

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Centurion BioPharma Corp Wholly-owned subsidiary of CytRx

Corporation (NASDAQ: CYTR)

Private oncology pre-clinical stage company

Discovered and owns full rights to LADR™ (linker activated drug release) and new companion diagnostic

Laboratory facilities and drug discovery team located in Freiburg, Germany

Administrative location in Los Angeles, CA


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Centurion BioPharmaHighlights

Albumin companion diagnostic (ACDx) is a ground breaking companion diagnostic in the preclinical stage that is being developed to work in conjunction with LADRTM

ACDx enhances the value of our pipeline because it enables a personalized medicine approach in development

Personalized medicine: by utilizing ACDx to select the optimal solid tumor patients for treatment, consistent impressive response rates and outcomes can be attained with treatment by LADRTM across solid tumor types (tumor agnostic development)

Centurion BioPharma filed US provisional patent application for ACDx in July 2018


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Vision and Development Strategies for ACDx + LADRTM

Study ACDx and LADRTM to work in conjunction in solid tumors LADRTM has demonstrated broad utility across solid tumor types (lung,

breast, ovarian, skin, head & neck) ACDx identifies tumors eligible for treatment with LADRTM

By identifying optimal patients with ACDx, LADRTM treatment will consistently deliver impressive response rates and outcomes to a broad group of solid tumor patients

OUR VISION: Personalized Medicine with Solid Tumor-Agnostic Treatment

Build tumor-agnostic

development plan

Easily train oncologists

on the technology

Establish treatment globally

Attain blockbuster

revenue

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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 a 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 has potential to transform solid tumor treatment

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

Tumor type: LXFL 529 (NSCLC) OVXF 899 (ovarian cancer) Study outline: Bilateral implantation TV ~100‒300 mm3 (left and

right flank) 4 mice


~40 min

~2 min

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ACDx results in tumor-bearing nude mice (LXFL 529)Representative 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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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)

Goal: accumulate drug in the tumor and minimize systemic toxicity

1 2 3


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Albumin as a Drug Delivery Vehicle Albumin Most abundant protein in human blood plasma Transport molecule Long half-life (20 days) Major source of essential amino acids (“fuel″) for cancer cells Localizes at tumor


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Mechanism of LADRTM Conjugates

Drug-linker conjugateis infused

Tumor cells

Albumin transports drug to the tumor and surrounding

microenvironmentLinker dissolves in the acidic (low pH) environment, releasing the drug payload

Rapid and specific binding to

circulating albumin

1

2

3

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CytotoxicAgent Linker

CytotoxicAgent Linker

Albumin


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Preclinical LADRTM data shows impressive efficacy Three poster presentations at AACR 2018

Robust anti-tumor activity in multiple tumor types

Impressive survival 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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AACR Poster: Efficacy LADR-7, 8


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AACR Poster: Efficacy LADR-9, 10


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Personalized Medicine

• Continue ACDx development to a first clinical trial so that cancer patients can be identified as candidates for an albumin-binding drug conjugate (LADRTM)

Clinical SPECT/CT Imaging

We expect high response rates toLADRTM

treatment when patients are selected utilizing ACDx

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Centurion BioPharma CorpPipeline

Preclinical Phase 1 Phase 2

LADR™ Albumin Binding Drug Conjugates

Auristatin ProgramLADR-7: AE-Keto-Sulf07LADR-8: AE-Ester-Sulf07

Maytansinoid ProgramLADR-9: PP072LADR-10: FN296

ACDx - Companion Diagnostic –patient identification across solid tumor types


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Momentum is building for cytotoxin + immunotherapy in oncology

Combining immunotherapy and cytotoxins is clearly becoming the 'wave of the future' for the treatment of cancer and Big Pharma are leading these breakthroughs

Immunotherapy and cytotoxin combinations represent a significant opportunity for the Centurion pipeline because our innovative platform can significantly improve the way cytotoxin therapy performs with immunotherapy


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Immunotherapy and Cytotoxin Combinations Have Enormous Promise

On October 30, 2018, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck & Co. Inc.) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).

First positive Phase III study results for a cancer immunotherapy combination in breast cancer, with Tecentriq® (Genentech/Roche) plus nab-paclitaxelSource: www.gene.com

Source: www.fda.gov

Centurion’s ground-breaking innovation in cytotoxin therapy can improve efficacy even further with immunotherapy combinations

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CytRx can build value with potential milestone/royalty payments along with our Centurion pipeline

OrphazymeMilestones

and Royalties

Orphazyme (“ORPHA.CO”): $120M in potential milestones + royalties on Arimoclomol (currently

undergoing clinical trials in 4 indications)

Centurion BioPharma

Pipeline

NantCellMilestones

and Royalties

NantCell: $343M in potential milestones + royalties on Aldoxorubicin

Oncology personalized medicine: companion diagnostic + treatment

Centurion BioPharma is a wholly-owned subsidiary of CytRx

20Source:www.orphazyme.com/presentations/company presentation

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CytRx value – Orphazyme milestones and royalties

OrphazymeMilestones

and Royalties

Orphazyme: $120M in milestones + royalties on Arimoclomol

• Orphazyme to engage with FDA and EMEA to determine path to making arimoclomol available in NPC

• Niemann-Pick is a high unmet need• Orphan drugs traditionally have a high price• Potential near term timing of payments to CytRx• In addition to NPC, ongoing clinical trials in Sporadic Inclusion

Body Myositis (sIBM), Gaucher Disease and ALS

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CytRx value – NantCell milestones and royalties

NantCellMilestones

and Royalties

NantCell: $343M in milestones + royalties on Aldoxorubicin

• Dr. Patrick Soon-Shiong is a South African/American surgeon, entrepreneur, and philanthropist. He is chair of NantWorks, LLC (which is the owner of NantCell), executive director of the Wireless Health Institute at the University of California at Los Angeles, and an adjunct professor of surgery at UCLA.

• NantCell, LLC licensed aldoxorubicin from CytRx in July 2017. As part of the license, NantCell made a strategic investment of $13 million in CytRx common stock at a price of $6.60 per share

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CytRx partnered Pipeline with NantCell - Aldoxorubicin

Preclinical Phase 1 Phase 2 Phase 3

2nd-Line Soft Tissue Sarcoma

2nd-Line Small Cell Lung Cancer

Combo with ifosfamide – STS

Combination Trials with Immunotherapy

Pancreatic Cancer

Squamous Cell Carcinoma

Triple-Negative Breast Cancer

Ph 2 – Fully enrolled; NantCell has IND

Ph 1b/2 – On going

Ph 1b/2 – On-going

Ph 1b/2 – NantCell has IND

Ph 3 – Completed; NantCell has IND

Ph 1b/2 – On-going

• Studied in over 600 patients with a favorable safety profile• Ongoing trials in combination with immunotherapies and cell based

therapies

Aldoxorubicin

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CytRx value – Centurion BioPharmapipeline

Centurion BioPharma

Pipeline

Oncology personalized medicine: companion diagnostic + treatment

Albumin companion diagnostic (ACDx)identifies tumors eligible for treatment with LADRTM

LADR (linker activated drug release) albumin binding drug conjugatesLADR-7LADR-8LADR-9LADR-10

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2017

Recent and Upcoming Catalysts

2018

1Q17: Met with the FDA for aldoxorubicin as a treatment for STS

2Q17: Oral presentation of aldoxorubicin Phase 3 STS data at ASCO

2Q17: Present updated Phase 1b/2 results from combination trial of aldoxorubicin and ifosfamide in advanced sarcomas at ASCO

3Q17: Announced global strategic alliance for aldoxorubicin with NantCell

4Q17: Regain Nasdaq listing compliance

4Q17: File patent applications for LADRTM

drug candidates

4Q17: Initiate activities for GMP manufacturing of LADRTM linkers

Represents a completed milestone

1Q18: NantCell initiated Ph 1b/2 combination clinical trial in metastatic pancreatic cancer and in advanced squamous cell carcinoma

1Q18: Nominate one or more ultra-high potency LADRTM conjugates for clinical development

2Q18: NantCell initiated Ph 1b/2 combination clinical trial in triple negative breast cancer

1H18: Begin partnership discussions for high potency LADRTM conjugates

1H18: Present data on LADRTM conjugates at major scientific meeting

3Q18: File patent application for companion diagnostic

By Dec 31, 2018: Goal - Strategic transactioncompletion date and close

Strategic transaction will determine next steps with pre-IND meeting, studies and filing of IND for first-in-human study with LADRTM drug conjugate and ACDx diagnostic


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Financial Summary 9/30/18 Cash Position No Debt

Shares Outstanding 33.6M

Options Weighted-average strike price: $10.67 2.7M

Warrants

Weighted-average strike price: $7.90 0.7M Including: NantCell warrant at $6.60; expires 01/2019 0.5M

Fully-Diluted Share Count 37.0M

$24.7M

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Conclusion

CytRx can build value with the following: Orphazyme $120M in potential milestones + royalties

NantCell $343M in potential milestones + royalties

Centurion BioPharma oncology personalized medicine pipeline Albumin companion diagnostic (ACDx)

Albumin binding drug conjugates (LADRTM-7, LADRTM-8, LADRTM-9, LADRTM-10)


CytRx (CYTR) Corporate Presentation€¦ · december 2018 non-confidential . nasdaq: cytr. fighting...

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Transcript of CytRx (CYTR) Corporate Presentation€¦ · december 2018 non-confidential . nasdaq: cytr. fighting...