Corporate Overview December 2018 Non-Confidential - NASDAQ: CYTR - CytRx Corporation
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NASDAQ: CYTR
FIGHTING CANCER WITH
CUTTING EDGE SCIENCE
Corporate Overview
December 2018
Non-Confidential
CytRx Safe Harbor Statement
THIS PRESENTATION CONTAINS FORWARD-LOOKING STATEMENTS THAT
INVOLVE CERTAIN RISKS AND UNCERTAINTIES. ACTUAL RESULTS
COULD DIFFER MATERIALLY FROM THOSE PROJECTED IN THE FORWARD-
LOOKING STATEMENTS AS A RESULT OF THE RISK FACTORS DISCUSSED
IN CYTRX REPORTS ON FILE WITH THE U.S. SECURITIES AND EXCHANGE
COMMISSION INCLUDING, BUT NOT LIMITED TO, THE REPORTS ON
FORM 10-Q FOR THE QUARTER ENDED SEPTEMBER 30, 2018.
1
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
FIGHTING CANCER WITH
CUTTING EDGE SCIENCE
2
Centurion BioPharma
Highlights
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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3
Vision and Development
Strategies for ACDx + LADRTM
OUR VISION:
Personalized Medicine with Solid Tumor-Agnostic Treatment
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
Build tumor- Easily train
Establish Attain
agnostic oncologists
treatment blockbuster
development on the
globally revenue
plan technology
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4
Companion Diagnostic:
ACDx (albumin companion dx)
When positively screened with ACDx, we believe patients will
Goal
have a very high response rate when treated with LADRTM.
ACDx is an imaging test that identifies albumin uptake in
What is
tumors. By determining if albumin is in the tumor, we can
ACDx? determine if treating with LADRTM (an albumin binding drug
conjugate) is appropriate. This is personalized medicine that is
highly valued by oncologists.
Uses Single Photon Emission Computed Tomography (SPECT),
How is ACDx commonly used by oncology practices throughout the world.
used?
ACDx and LADR will be a products sold to oncology practices.
5
ACDx has potential to transform
solid tumor treatment
OUR VISION:
Personalized Medicine with Solid Tumor-Agnostic Treatment
ACDx creates value when working as a companion diagnostic with LADRTM
Improve
Identify eligible Improve probability of Rationale for Justification for
patients for outcome of breakthrough payer premium
treatment clinical trials status and reimbursement pricing
approval
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6Preclinical SPECT/CT Imaging
with 111In-C4-DTPA
Establish 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 ~40 ~2 min
right flank) min
4 mice
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7ACDx 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 of
elimination
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8TM
LADR Platform Overview
Goal: accumulate drug in the tumor and minimize systemic toxicity
1 2 3
1. Ultra High Potency 2. Cleavable Linker 3. Targeting
Drug Payload • Novel linker keeps the • Ensures rapid and
• Payloads are 10-1,000 highly potent drug selective binding to
times more potent than payload inactive until the circulating serum albumin
standard anti-cancer conjugate reaches the • Serum albumin transports
agents tumor the LADR™ drug to the
• Similar to those used for • The linker is then cleaved tumor
ADCs (auristatins, which activates the
maytansinoids) payload
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9Albumin 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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10Mechanism of LADR Conjugates
TM
Cytotoxic Albumin
Agent Linker
2
1 Rapid and specific
binding to 3
Cytotoxic
Agent Linker circulating albumin
Drug-linker conjugate Tumor cells
is infused
4
Albumin transports
drug to the tumor
and surrounding
Linker dissolves in the acidic (low pH) microenvironment
environment, releasing the drug payload
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11Preclinical LADR data shows
TM
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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12AACR Poster: Efficacy LADR-7, 8
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13AACR Poster: Efficacy LADR-9, 10
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14Personalized 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)
We expect high
response rates to
LADRTM
treatment when
patients are selected
utilizing ACDx
Clinical SPECT/CT Imaging
15Centurion BioPharma Corp
Pipeline
Preclinical Phase 1 Phase 2
LADR™ Albumin Binding
Drug Conjugates
Auristatin Program
LADR-7: AE-Keto-Sulf07
LADR-8: AE-Ester-Sulf07
Maytansinoid Program
LADR-9: PP072
LADR-10: FN296
ACDx - Companion Diagnostic –
patient identification across
solid tumor types
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16Momentum 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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17Immunotherapy and Cytotoxin
Combinations Have Enormous Promise
Centurion’s ground-breaking innovation in cytotoxin
therapy can improve efficacy even further with
immunotherapy combinations
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).
Source: www.fda.gov
First positive Phase III study results for a cancer
immunotherapy combination in breast cancer, with
Tecentriq® (Genentech/Roche) plus nab-paclitaxel
Source: www.gene.com
18CytRx can build value with potential
milestone/royalty payments along with our
Centurion pipeline
Orphazyme Orphazyme (“ORPHA.CO”): $120M in potential
Milestones milestones + royalties on Arimoclomol (currently
and Royalties undergoing clinical trials in 4 indications)
NantCell
Milestones
NantCell: $343M in potential milestones +
and Royalties royalties on Aldoxorubicin
Centurion
BioPharma
Oncology personalized medicine: companion
Pipeline diagnostic + treatment
Centurion BioPharma is a wholly-owned subsidiary of CytRx
19Source:www.orphazyme.com/presentations/company presentation 20
CytRx value – Orphazyme milestones
and royalties
Orphazyme
Milestones
Orphazyme: $120M in milestones + royalties on
and Royalties 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
21CytRx value – NantCell milestones
and royalties
NantCell
NantCell: $343M in milestones + royalties on
Milestones
and Royalties 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
22CytRx partnered Pipeline
with NantCell - Aldoxorubicin
Aldoxorubicin Preclinical Phase 1 Phase 2 Phase 3
2nd-Line Soft Tissue Sarcoma Ph 3 – Completed; NantCell has IND
2nd-Line Small Cell Lung Cancer Ph 2 – Fully enrolled; NantCell has IND
Combo with ifosfamide – STS Ph 1b/2 – NantCell has IND
Combination Trials with Immunotherapy
Pancreatic Cancer Ph 1b/2 – On-going
Squamous Cell Carcinoma Ph 1b/2 – On-going
Triple-Negative Breast Cancer 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
23CytRx value – Centurion BioPharma
pipeline
Centurion
BioPharma
Oncology personalized medicine: companion
Pipeline diagnostic + treatment
Albumin companion diagnostic (ACDx)
identifies tumors eligible for treatment with LADRTM
LADR (linker activated drug release) albumin binding drug conjugates
LADR-7
LADR-8
LADR-9
LADR-10
24Recent and Upcoming Catalysts
2017 2018
1Q18: NantCell initiated Ph 1b/2 combination
1Q17: Met with the FDA for aldoxorubicin
clinical trial in metastatic pancreatic cancer and
as a treatment for STS
in advanced squamous cell carcinoma
2Q17: Oral presentation of aldoxorubicin
1Q18: Nominate one or more ultra-high potency
Phase 3 STS data at ASCO
LADRTM conjugates for clinical development
2Q17: Present updated Phase 1b/2 results
2Q18: NantCell initiated Ph 1b/2 combination
from combination trial of aldoxorubicin
clinical trial in triple negative breast cancer
and ifosfamide in advanced sarcomas at
ASCO 1H18: Begin partnership discussions for high
potency LADRTM conjugates
3Q17: Announced global strategic alliance
for aldoxorubicin with NantCell 1H18: Present data on LADRTM conjugates at
major scientific meeting
4Q17: Regain Nasdaq listing compliance
3Q18: File patent application for companion
4Q17: File patent applications for LADRTM
diagnostic
drug candidates
By Dec 31, 2018: Goal - Strategic transaction
4Q17: Initiate activities for GMP
completion date and close
manufacturing of LADRTM linkers
Represents a completed milestone 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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25Financial Summary 9/30/18
Cash Position $24.7M
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
26Conclusion
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)
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