NASDAQ: CKPT CORPORATE PRESENTATION - January 2021
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NASDAQ: CKPT
CORPORATE PRESENTATION
January 2021
Safe Harbor Statement
This presentation contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements are often, but not always, made through the use of
words or phrases such as “anticipates”, expects”, plans”, believes”, “intends”, and similar words or
phrases. Such statements involve risks and uncertainties that could cause Checkpoint Therapeutics’
actual results to differ materially from the anticipated results and expectations expressed in these
forward-looking statements. These statements are only predictions based on current information and
expectations and involve a number of risks and uncertainties. Actual events or results may differ
materially from those projected in any such statements due to various factors, including the risks and
uncertainties inherent in clinical trials, drug development, and commercialization. You should carefully
read the Special Cautionary Notice Regarding Forward-Looking Statements and the Risk Factors
sections of Checkpoint Therapeutics' public filings with the Securities and Exchange Commission (SEC)
to better understand the risks and inherent uncertainties in its business. You are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of the date hereof. All
forward-looking statements are qualified in their entirety by this cautionary statement and Checkpoint
Therapeutics undertakes no obligation to update these statements, except as required by law.
2
Checkpoint Therapeutics
Clinical-stage biopharmaceutical company
focused on treatments for patients with solid tumor cancers
• Potential best-in-class anti-PD-L1 mAb with two-fold mechanism of action
COSIBELIMAB
• Registration-enabling study in cutaneous squamous cell carcinoma >80% enrolled
• Positive interim results presented at 2020 ESMO Congress and SITC
• Full top-line results expected 2H 2021 to support marketing approval applications
• Oral, third-generation, irreversible kinase inhibitor against selective EGFR
mutations in non-small cell lung cancer (NSCLC)
CK-101
• Positive Phase 1 interim results presented at 2018 World Lung Conference
• Potential Phase 3 in front-line EGFR mutation-positive NSCLC
3
Checkpoint Therapeutics Pipeline
Phase 3 / Next Expected
Indication Preclinical Phase 1 Phase 2* Pivotal Milestone
cSCC Pivotal study full
Single Agent
Metastatic top-line results 2H 2021
cSCC
Pivotal study
Locally Single Agent
enrollment ongoing
Cosibelimab Advanced
Anti-PD-L1
Antibody cSCC
Adjuvant / Single Agent Initiate Phase 2
Neoadjuvant
NSCLC Cosibelimab +
Initiate Phase 3
1L Metastatic Pemetrexed +
registration study
Non-Squamous Platinum
CK-101
NSCLC Potential Phase 3
3rd Generation EGFR Single Agent
1L EGFR mut+ registration study
Inhibitor
CK-103 BET Inhibitor Solid Tumors Initiate Phase 1
Earlier
Complete IND-enabling
Stage CK-302 Anti-GITR Solid Tumors
studies
Programs
CK-303 Anti-CAIX Solid Tumors Candidate selection
cSCC: cutaneous squamous cell carcinoma; NSCLC: non-small cell lung cancer; 1L: first-line.
* Some indications will not require a non-pivotal Phase 2 clinical trial prior to beginning pivotal Phase 3.
4IMMUNO-ONCOLOGY
COSIBELIMAB (CK-301)
FULLY-HUMAN ANTI-PD-L1 ANTIBODY
5Anti-PD-(L)1 Market
• Current annualized sales among the approved anti-PD(L)1 class
is ~$25B and expected to grow to $50B
• Competition is indication-specific
• Entire class priced at ~$165,000 patient/per year
– Costly to U.S. healthcare system
– Limited funding/reimbursement ex-U.S.
6Checkpoint’s Development Strategy
• Develop a differentiated, potentially best-in-class anti-PD-L1
– Cosibelimab: Licensed from Dana-Farber Cancer Institute;
optimized at Adimab
Step 1 – Obtain initial Step 2 – Expand into Step 3 – Combination
approvals in cSCC larger indications Studies
Obtain marketing Expand into Evaluate cosibelimab
approvals in cutaneous substantial, multi- in combination with
squamous cell billion dollar synergistic molecules
carcinoma (“cSCC”) and follow-on indications to obtain proprietary
launch at lower price by utilizing established treatment options.
point than competition registration study
to gain market designs, starting with
dominance while non-small cell lung
maintaining >90% gross cancer (“NSCLC”).
profit margins.
7Cosibelimab: A Differentiated Anti-PD-L1
Fully-human anti-PD-L1 mAb with a two-fold mechanism of action
for potential enhanced efficacy
PRIMARY MECHANISM OF ACTION SECONDARY MECHANISM OF ACTION
Cosibelimab blocks PD-L1 to reactivate T-cells Cosibelimab has a functional Fc region that may bind
with >99% tumor target occupancy and activate NK cells to enable cell-mediated ADCC
Tumor Cell
Activated T-Cell NK Cell
Cosibelimab
PD-1 PD-L1
PD-L1 FcR
TCR MHC
PD-1 PD-L1 Cosibelimab
Cosibelimab
FcR - Fragment crystallizable (Fc) receptor NK cell - Natural killer cell PD-1 - Programmed-death 1
MHC - Major histocompatibility complex TCR - T-cell receptor PD-L1 - Programmed-death ligand 1
8Cosibelimab: A Differentiated Anti-PD-L1
High-affinity anti-PD-L1 with sustained >99% tumor target
occupancy to restore T-cell function…
Human PD-L1 Binding Affinity
Antibody KD (M)
Exhibits stronger binding affinity to PD-L1
cosibelimab 8.47e-10 than atezolizumab in vitro
atezolizumab 2.02e-09
Tumor Target Occupancy
Exhibits sustained >99% tumor target occupancy at trough at steady state
Zoomed in
Poster: AACR Annual Meeting 2017. 9Cosibelimab: A Differentiated Anti-PD-L1
Functional Fc domain capable of inducing antibody-dependent cell-
mediated cytotoxicity (ADCC)
Induction of ADCC
Induces natural killer (NK) cell-mediated tumor cell lysis
25%
Percent Cytotoxicity
• Human peripheral blood
mononuclear cells (PBMC)
20%
15%
from different donors were
incubated with PD-L1+ cell
10% line SU-DHL-1 in the presence
of cosibelimab or control
5% antibody (IgG1)
0%
IgG1 CK-301 IgG1 CK-301 • Dose-dependent cytotoxicity
Donor A Donor B
Poster: AACR Annual Meeting 2017. 10Cutaneous Squamous Cell Carcinoma
Initial Planned Indications
Metastatic and locally Second most common Analysts project $1B+ Libtayo® and Keytruda®,
advanced cSCC are the form of skin cancer, market potential cSCC. anti-PD-1s, are the only
initial planned indications responsible for an approved treatments for
for cosibelimab. estimated 7,000 deaths advanced cSCC.
per year in the U.S. Approved based on
response rate in
~75-100 patient studies.
11Cutaneous Squamous Cell Carcinoma
Cosibelimab Ongoing Registration-Enabling Trial
• Global, open-label, multicohort study in advanced cancers
evaluating cosibelimab administered as a fixed dose of:
– 800 mg every two weeks (q2w), and
– 1200 mg every three weeks (q3w)
• Pivotal cohorts in metastatic and locally advanced cSCC
– Target enrollment: ~75 patients per cohort
– Primary endpoint: Objective response rate by central review
• FDA feedback supports plan to submit Biologics License
Application(s) supported by data from ongoing study
12ESMO 2020: Phase 1 Interim Data
Metastatic cutaneous Squamous Cell Carcinoma
Cosibelimab response rates vs approved anti-PD-1s
Objective
Tumor Response Complete
# of Patients Response Rate
by RECIST 1.1 Response Rate
(95% CI)
51.4%
Cosibelimab 37 13.5%
(34, 68)
46.7%
75 5.3%
(35, 59)
34.3%
105 3.8%
(25, 44)
Sources: Cosibelimab interim results by investigator assessment, ESMO Congress 2020. Libtayo package insert dated September 2018; Keytruda package
insert dated June 2020. These published results are provided for context; cosibelimab has not been compared in a randomized study to Libtayo or Keytruda. 13ESMO 2020: Phase 1 Interim Data
Metastatic cutaneous Squamous Cell Carcinoma
Rapid and durable responses; 84% of responses ongoing
Longest duration of response: 24+ months
Complete response
Partial response
Stable disease
Progressive disease
Ongoing treatment
Patients with Response
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28
Months 14ESMO 2020: Phase 1 Interim Data
Emerging Safety Differentiation vs Anti-PD-1s
• 114 patients with advanced cancers Treatment-Related AEs in ≥5 Patients
treated with cosibelimab Fatigue
‒ Longest duration: 31 months Rash
Hypothyroidism
Anemia
• Treatment‐related AEs (TRAEs): Infusion reaction
Nausea
‒ Well-tolerated profile Diarrhoea
‒ Grade ≥3: 6 pts (5.3%) AST increased
Decreased appetite
Substantially lower than the ≥20% G3+ Hyperthyroidism
TRAEs reported by market leading Lipase increased
anti-PD-1s Weight decreased
Keytruda®: 26.6%; Opdivo®: 21% 0% 5% 10% 15% 20%
Grade 1 Grade 2 Grade 3
Keytruda® (Keynote-024 lung) Opdivo® (CheckMate 142)
15Metastatic cutaneous Squamous Cell Carcinoma
Expected Near-Term Milestones
• 1Q 2021: Complete enrollment in metastatic cSCC
• 2H 2021: Full top-line results
• 1H 2022: Planned BLA/MAA submissions
• Ongoing: Potential business development activities
16Non-Small Cell Lung Cancer
$10 Billion Annual Market
Efficacy data from Phase 1 supports NSCLC Phase 3 trial
Non-Small Cell Lung Cancer with High PD-L1 Expression and
without EGFR/ALK Alterations
Cosibelimab
N=25 N=154 N=107
ORR: 44% ORR: 45% ORR: 38%
(95% CI: 24, 65) (95% CI: 37, 53) (95% CI: 29, 48)
Median PFS: 10.3 months Median PFS: 10.3 months Median PFS: 8.1 months
(95% CI: 7, 14) (95% CI: 7, NR) (95% CI: 7, 11)
SITC 2020 Keynote-024 IMpower110
TPS: tumor proportion score (cosibelimab and Keytruda by 22C3, Tecentriq by SP142 immunohistochemical assay). ORR: Objective response rate.
PFS: Progression-free survival. These published results are provided for context; cosibelimab has not been compared in a randomized study to
Keytruda or Tecentriq. 17Non-Small Cell Lung Cancer
Planned Phase 3 Trial
Study Population
1L non-squamous NSCLC
EGFR sensitizing mutation negative
ALK translocation negative
Stratification
Never vs former/current smoker
Cisplatin vs carboplatin
PD-L1 TPSPricing and Reimbursement Assessment
Payer Access Study
Current environment for PD-(L)1 therapy in US
– No preferred coverage under most insurance plans as approved
drugs are perceived to show little differentiation in clinical
outcomes and price
– Payers restrict access to labeling via Prior Authorization due to
high costs and limited discounts offered on approved drugs
– With approximately half the covered patients, CMS reimburses PD-
(L)1 drugs based on rates set by commercial payers.
A survey of major commercial payers indicates that a ~20-30%
discount at launch relative to peers could drive the removal of
Prior Authorization and the selection of cosibelimab as
first choice therapy in the US.
19TARGETED THERAPY
CK-101
3RD GENERATION EGFR INHIBITOR
20EGFR Mutation-Positive NSCLC
Large Market Dominated by One Therapy
~20% of NSCLC 1st and 2nd gen 3rd gen EGFR Tagrisso®
patients have EGFR inhibitors inhibitors target (osimertinib) is the
activating lead to acquired EGFR activating only approved 3rd
mutations in EGFR resistance, mainly mutations and gen EGFR inhibitor
(i.e., deletion 19) due to T790M T790M resistance
that can be resistance mutation leading $4B in annualized
selectively targeted mutation to longer tumor sales; projected to
with an EGFR responses reach $8B+ in 2025
inhibitor
21Currently Approved 3rd Gen EGFR Inhibitor
Safety Limitations
Tagrisso® (osimertinib) Warnings and Precautions:
QTc prolongation (4.5%), interstitial lung disease (3.9%), cardiomyopathy (2.6%)
Phase 3 (FLAURA) Study Adverse Events
63% 59% 58% 58% 51%
Lymphopenia Anemia Diarrhea Rash Thrombocytopenia
(8% G3)
41% 37% 35%
Neutropenia Hyperglycemia Nail Toxicity
13% of patients permanently discontinued due to AEs
22World Lung 2018: CK-101 Phase 1 Interim Data
Emerging Safety Differentiation
Most CK-101
• CK-101 was well-tolerated Common (≥3pts) All Patients Treated (N=37)
Treatment-Related
− Most adverse events were Adverse Events,
Grade 1-2 n (%) All Grades Grade 3 Grade 4
Nausea 6 (16%) - -
− No DLTs or treatment-related
SAEs Diarrhea 5 (14%) 1 (3%) -
Lacrimation incr. 5 (14%) - -
Vomiting 4 (11%) - -
• No events of: Bilirubin incr. 3 (8%) 2 (5%) -
− Interstitial lung disease Rash 3 (8%) 2 (5%) -
ALT incr. 3 (8%) 1 (3%) -
− Pneumonitis
AST incr. 3 (8%) 1 (3%) -
− QTc prolongation Pruritus 3 (8%) 1 (3%) -
Dysphonia 3 (8%) - -
− Cardiomyopathy
Hypoesthesia 3 (8%) - -
Oral Presentation: World Lung Sept 2018 23World Lung 2018: CK-101 Phase 1 Interim Data
Efficacy in EGFRm+ NSCLC
• 75% (6/8) confirmed ORR in Change in Total Tumor Burden from Baseline
treatment-naïve pts 20%
‒ Phase 3 target population 1L 1L 1L 1L 1L 1L 1L 1L
0%
• All TKI-naïve and TKI-failure pts
-20%
‒ 53% (10/19) ORR
-40%
‒ 84% (16/19) pts had target
lesion reductions versus
-60%
baseline
‒ 100% (19/19) disease control -80%
rate (stable disease or better)
-100%
• 60% (3/5) pts with brain 0% change TKI-naïve (Activating Mutation) TKI Failure (T790M)
metastases at baseline achieved
1L = Treatment-naïve
partial response with intracranial
reductions
Oral Presentation: World Lung Sept 2018 24CK-101: Planned Phase 3 Study Design
Similar design as used by Tagrisso® and Vizimpro®
Study Population
1L NSCLC with
EGFR mutations
Randomization
Total Pts: ~400 (2:1)
1st Gen EGFRi:
CK-101
Iressa (gefitinib)
Primary Endpoint: PFS
Progressive Disease Tagrisso: 18.9 vs 10.2 mths Progressive Disease
Vizimpro: 14.7 vs 9.2 mths
Follow-Up Follow-Up
Anticipate ~24-30 months to reach PFS endpoint
Tagrisso: 3rd generation EGFRi; Vizimpro: 2nd generation EGFRi. 25Investment Highlights
Compelling Favorable interim clinical data from lead clinical programs
product • Cosibelimab - Positive interim results presented from ongoing pivotal cSCC trial
pipeline • CK-101 - Positive interim results from Phase 1 trial presented at 2018 World Lung
Focus on billion dollar markets
Large market
• Cosibelimab - cSCC: $1B+ potential market with only PD-1 therapy approved
opportunities
• CK-101 - NSCLC: $8B+ potential market with only one approved 3rd generation EGFRi
Key clinical milestones expected
Multiple
• Cosibelimab – Registration-enabling study in metastatic cSCC >80% enrolled, with full
upcoming
top-line results anticipated 2H 2021. Phase 3 NSCLC study planned.
catalysts
• CK-101 - Potential Phase 3 registration study
IP extends well into 2030’s
Strong IP
• Cosibelimab - Composition of matter patent issued in U.S., expiring no earlier than 2038
portfolio
• CK-101 - Composition of matter patents issued in U.S./EU, expiring no earlier than 2034
Capitalized to reach pivotal clinical trial results for cosibelimab
Solid balance • $42M in cash reported at September 30, 2020; cash runway into 2022
sheet • No debt
26NASDAQ: CKPT
CORPORATE PRESENTATION
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