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SFA Therapeutics - Corporate Overview 9 19 2024

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TM

Treating the root cause of autoimmune disease

TM

TM

Ira C. Spector, PhD, MBA, Co-Founder & CEO


Corporate Overview

19 September 2024
SFA Therapeutics is focused on root causes of autoimmunity
Potential applications in multiple autoimmune & inflammatory diseases

Over 300 Million


people suffer from
autoimmune diseases;
Over 25% have
Multiple Autoimmune
Syndrome

Pipeline Market Opportunity Exceeds $200B 2


SFA Therapeutics Pipeline: Autoimmune Platform with Strong Clinical Data
Pipeline includes 9 assets in dermatology, autoimmune diseases, liver diseases and oncology
Preclinical Phase 1 Phase 2 Phase 3

Psoriasis
SFA-002
and Autoimmune Diseases

Adjunctive therapeutic for High Potential Pipeline:


SFA-009
pancreatic cancer
• Robust psoriasis market
Dermatology opportunity due to durable
SFA-003
Bullous Pemphigus responses observed
• Gateway to autoimmune
Oncology (HCC)
SFA-001 FDA Orphan Drug Designation for HCC
diseases, patents cover 40
autoimmune diseases
MASH (fibrosis) • Additional assets in
SFA-001N Phase 1b: IND authorized for FDA for clinical trial in MASH dermatology, autoimmune
and immuno-oncology
Other indications including Uveitis, Relapse Recurrence in CML/AML, and
other autoimmune diseases • Combination therapies with
existing drugs also studied
3
SFA-002 Significantly Reduces Psoriasis Lesions, is effective
And, durable responses were observed in two psoriasis patients in Phase 1a clinical trial
Patient with severe
psoriasis for > 25 years
Before SFA-002
✓ Clinically significant
Treatment
reduction of psoriasis
lesions
• PASI 90

✓ No adverse events

After Treatment,
✓ Durable response
Off Treatment • Patients treated for
> 3 Years over 1 year remain off
treatment for > 3
years with no return
of symptoms
PASI: Psoriasis Area and Severity Index 4
Problem: In Autoimmune Disease, the current standard of care is to treat symptoms
This can lead to major side effects; and patients, payors and physicians are not satisfied
Total Market in Autoimmune SFA Focus Areas:

$40B Targeted disease prevalence ranges from


Psoriasis
4-4.5% of population (350M people)
$121B High growth disease areas due to unmet
Other Autoimmune Diseases (RA, MS, Lupus, AS, Bullous Pemphigoid, Uveitis)
needs with CAGRs of 5.5% to 11%

Current treatments range from $50,000-


Total Market in Preclinical Areas: $80,000 per year, large healthcare burden

$20B Majority of patients are >40 years old; aging


Liver Disease
global populations will further impact

Current drugs treat symptoms, not the


$28B disease
Select Other Target-mediated diseases (AML, CML)

SFA-002 Pipeline Market Opportunity Exceeds $200B 5


Problem: Major market need for a safe, highly effective, oral drug for
moderate to severe psoriasis - 2/3 of patients fail treatment in < 2 years

Aging, high-risk population


9% CAGR (2023-2030), $52B market (2030)

PsO can change from mild to moderate or severe


without warning

Systemic treatments mainly for Moderate-Severe


due to side effects

Moderate PsO (3-10% BSA) potentially undertreated


with topicals- market will expand with effective oral

In some Northern European countries, psoriasis prevalence is as high as 8-11% 6


SFA focused on psoriasis first as a gateway to autoimmune disease

• Current treatments:
- treat single channels in a complex disease
- most require injections
- antibody formation limits treatment duration
- high patient, payor & physician dissatisfaction
- high failure rate with current drugs

• SFA-002 is an oral drug with both high efficacy and safety


• Psoriasis is just the first indication; potential to build major brand
• SFA-002 has shown superior efficacy and durable responses
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SFA-002 Method Of Action
SFA-002
Summary of MOA
Small molecule that acts on
GPCR Membrane multiple therapeutic pathways
Channel
Inhibits known pathways of
pro-inflammatory cytokines
(IL-17, IL-23, TNF-α, and IFN-y)
Treg Upregulation
Pro- Increases Treg differentiation
Anti- Immune cell inflammatory (thus up-regulates anti-
inflammatory IL-23, IL-17, inflammatory IL-10 and
Modulation TNF-α, INF-y
suppresses autoimmunity)
IL-10
Acts as an immunomodulator

High therapeutic index


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SFA-002 works differently than current drugs by simultaneously targeting
multiple disease pathways, combining high efficacy with low toxicity

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SFA-002:

HIGH
Competitive Position
• Expand the market SFA002
to more patients- many are Humira
undertreated and market can be Cimzia
expanded Enbrel

Safety
Remicade
Simponi
• Disrupt competition Taltz
Cosentyx
only immunomodulator with: Sotyk2u
• Durable effect
Otezla
• Disease modification
• Strong efficacy and safety
profile in an oral drug
LOW

LOW HIGH
Efficacy
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Copyright 2024 SFA Therapeutics. All rights reserved.
SFA-002 Phase 1b Demonstrated Significant Results at 12 Weeks
Significant clearance and no adverse events. Phase 2 ready. Clearance in palmoplantar and scalp

Before After
Before After

Before After
Before After Before After 11
Phase 1b Cohort 1 Topline Analysis
Data demonstrate significant clearance and no adverse events
Potential for durable effect (observed in Phase 1A) to change treatment and the market
SFA-002 Treatment Profile
Snapshot analysis as of 8/27/23*

Endpoint PASI <25 PASI 25-49 PASI 50-74 PASI 75-89 PASI 90-100

N = 14 (%) 1 (7%) 0 4 (29%) 6 (43%) 3(21%)

• 93% of patients showed PASI > 50 improvement


• 80% of patients showed PASI > 75 improvement @ 12 weeks
• 100% - Two complete (PASI 100) responses observed
• Rapid onset (in as little as 6 weeks)
• No adverse events are noted. Safety (physical exam and blood tests)
is within normal limits.
PASI: Psoriasis Area of Severity Index
N = 14 due to 2 protocol violations
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* Includes 6 subjects who are on a 3-month extension
M & A in Oral Autoimmune Market is Very Active; SFA has 9 drugs
The market for oral autoimmune drugs is early and very active, with big pharmas making early-stage acquisitions
Oral Drug/Company Developer Deal Terms Annual Sales
SFA-002 SFA Therapeutics Series A underway Phase 1b, Cohort 1
Sold to Takeda for $4B in cash plus $2B in
Nimbus Nimbus was VC backed Phase 2
milestones
SOTYK2U Bristol Myers Squibb Internal development $2.9B forecast by 2029
JNJ IL-23 Protagonist Licensed by JNJ for over $1B Phase 2
Piclidenoson Can Fite Nasdaq Filing
BMS sold to Amgen for $10B, after BMS
Otezla Celgene $2B
acquired Celgene
Lilly Dice Therapeutics Acquired Dice for $2.4B tbd
Sonelokimab MoonLake Market cap $3B Phase 2

Merck Prometheus BioSciences $10.8B tbd

Merck Acceleron Acquired for $11.5B tbd

Apogee Therapeutics Apogee IPO $345M tbd 13


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Ask- Program 1:
$25M Series B to accelerate clinical development in psoriasis

2022 2023 2024 2025-2026

Phase 1B Studies1 Funded • Phase 2 Ready


Phase 2/3
$11 M
Study2 • Demonstrated efficacy & safety
Additional Tox Studies $2M
• Seeking $25M to accelerate
Formulation Optimization $2M
Ph2/3 adaptive study, designed
Manufacturing / Analytic Methods $2M to position SFA-002 as First-in-
Class and Best-in-Class
Bioequivalence & Dose-Ranging $3M immunomodulator in plaque
psoriasis and other autoimmune
Corporate $3M
diseases
Other Costs (i.e., IP protection, milestone payments, reserves, develop Ph3 estimate) $2M
1 Phase 1B Studies (data readout beginning mid-2023): 30 subjects to optimize formulation, 2 cohorts of 15 subjects
2 Phase 2/3 Study (data readout early 2026): 200 subjects, designed to determine PASI & IGA scores
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Note: Other costs include ongoing IP protection, milestone payments, reserves, Ph3 readiness and execution
Ask- Program 2: Platform Development - SFA is not a single asset company
Estimated funds needed to advance key preclinical assets into Phase 1B
2025-2027 • Technology restores
Underway: single subject pancreatic study. Several possible MOA’s,
Oncology
opportunity to reduce concurrent chemotherapy and reduce toxicity. $ 10 M homeostasis
Pancreatic cancer Statistically significant preclinical data for combination, patents pending
• Immunomodulation of
Oncology FDA Orphan Drug Designation. Cytotoxic to the two most prevalent $ 2M
Hepatocellular carcinoma human cancer cell lines without damage to normal liver cells. multiple parallel disease
channels
Dermatology Phase 1b study showed strong responses in difficult to treat $ 2M
Palmoplantar & Scalp Psoriasis scalp and palmoplantar psoriasis, funds are for a sub-study. • Proteomics demonstrate
clear pathways and
Dermatology Upregulation of IL-10 shows potential to treat AT with oral drug. $ 5M receptor targets
Atopic Dermatitis Phase 1b/2 trial proposed.
associated with specific
Single subject compassionate-use trial achieved complete remission.
diseases
Dermatology $ 3M
Bullous Pemphigus Phase 1b clinical trial in 20 subjects proposed.
• Off-target side effects are
Phase 1b trial ready. IND authorized by FDA for trial in 20 subjects, to not an issue due to return
MASH (fibrosis) evaluate safety, validate biomarker and measure changes in fibrosis.
$ 1M
to homeostasis and no
$23 M genotoxicity
Total
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SFA is Led by an Experienced Leadership Team
Over 40 drugs developed (including Enbrel), ten prior exits, and over $600M in prior raises

Ira C. Spector, PhD, MBA James Kirwin, MBA


CEO, Co-Founder COO, Head of Clinical Operations

Mark Feitelson, PhD Shawn P. O’Brien


CSO, Co-Founder Chairman

Alla Arzumanyan, PhD Rob Dickey, IV


CDO, Co-Founder CFO

King Lee, PhD Stefan Weiss, MD


VP, Regulatory Affairs CMO

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Executive Summary:
SFA-002 is a highly differentiated oral drug that has the potential to significantly change
psoriasis landscape & patients’ lives by treating the root cause of autoimmune disease
Raising $25M to complete Phase 2/3 clinical trial in PsO and approx. $25M for other assets

1. SFA-002 solves a major unmet need with a disease-modifying potential

2. Clinical data show compelling efficacy and safety (Ph1a & Ph1b), e.g., the drug works

3. SFA-002 is a First-in-class, Best-in-class therapeutic that is Phase 2 ready


4. Strong IP protection (Composition of Matter) through 2043 (15 patents issued/allowed,
18 pending in 12 countries)

5. Potential to treat over 40 potential autoimmune diseases (RA, MS, pediatric PSO, etc.)

6. Potential to be an “oral Enbrel” or an “oral Humira” e.g., blockbuster potential


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Actual SFA-002 Phase 2 tablets

Thank You

TM

Contact Information:
Ira C. Spector, PhD, MBA
Co-Founder & CEO
iraspector@sfatheraputics.com
267-584-1080
SFA-002 MOA in Psoriasis Works Differently than Current Drugs by Blocking Multiple Channels Simultaneously

TNFα: API facilitates


degradation of mRNA of TNFα
(Fukae 2005).
NF-κB: inhibits IκBα
degradation (IκBα is inhibitor of
NF-κB) (Segain 2000),
upregulates PPARγ (nuclear
hormone receptor capable of
inhibition the NF-κB-dependent
transcriptional activation)
(Canani 2012).
IFN-γ: IFN-γ acts via STAT1
signaling (Krause 2006). API
inhibited activation of STAT1
through blocking its Tyr/Ser
phosphorylation, nuclear
translocation, and DNA binding
(Klampfer 2003).
IFN-y promotes IL-23
production. 19
Competitive Landscape: SFA002 is one of the only potent oral drugs
The Future of Psoriasis Treatment is Oral
SFA002 is the ONLY Multiple Target Asset and is the ONLY Immunomodulator
10

8
# of Brands / Assets

Stelara

7 BAT2206
AK101
6
Biosimilars:
DMB-3116
5 ABP-654 Humira
FYB-202 Remicade
SB-17 Enbrel
4
CT-P43
AVT-04 SCT-630 Skyrizi
3 Cosentyx Tremfaya
Biosimilars: Siliq
ABP-501 Taltz IBI-112
2 ABY-035
301s Mirikizumab AK-111
Otezla deucravaciti AUR-101
608*
nib (BMS) SHR-1314
1 BCD-085
Orismilast* cedirogant-
0
Hemay-005 NDI-034858 (ABBV-157) Ilumya Cimzia CF-101 Jaktinib KBL-697 SCD-044 Bimzelx SFA-002
IL-12, IL-23

RORγt

IL-17A, IL-23, TNF-⍺, IFN-γ


Lactobacillus gasseri
TYK2

PEG-TNF-⍺

IL-17F, IL-17A
S1P1a
TNF-⍺

IL-17A

IL-23A

JAK 1/2

IL-23A

IL-17A
PDE-4

A3AR agonist
MOA Targets and PASI Scores
Injectable Oral

Copyright 2024 SFA Therapeutics 20


SFA-001N has shown a functional cure for MASH (NASH)
In a single-subject Compassionate-Use Study:
Patient with Stage 3 MASH (NASH) has gone from being a transplant candidate to
being clear of any disease.
✓ Improvement from Stage 3 NASH to clear with no lesions after 4 years of treatment
• Validated using multi-spectral MRI and liver functionality lab tests
✓ No adverse events
✓ Normal liver enzymes with no evidence of disease
✓ Patient remains on treatment routine blood tests and annual imaging
✓ Backed up by two preclinical studies and 2 patents

Phase 1b: IND authorized by FDA for clinical trial in MASH


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MASH: Metabolic Disfunction-Associated Steatohepatitis; formerly called Non-Alcoholic Steatohepatitis (NASH)
SFA-009 has stabilized pancreatic cancer in a combo study
In a single-subject Compassionate-Use Study:
Patient with Stage 3 Pancreatic Cancer has gone from being inoperable with a 5cm tumor
to being stable with no metastases and a 4 cm tumor in 6 months.
(From a “death sentence to stable”)
✓ No metastases observed
✓ Combination with standard of care chemo enabled reduction of chemo dosage to 1/3
and significantly reduced side effects
✓ Patient is still being followed after 6 months of treatment
✓ Significantly improved quality of life compared with standard chemotherapy
✓ Backed up by two preclinical studies
✓ 2 patents filed
Phase 1b study pending Series A funding
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MASH: Metabolic Disfunction-Associated Steatohepatitis; formerly called Non-Alcoholic Steatohepatitis (NASH)
SFA’s pipeline includes 9 drugs focused in autoimmune diseases and oncology
Compund Indications Addressable Market Target Product Profile Discovery Preclinical Phase 1 Phase 2 Phase 3 NDA Submission
AUTOIMMUNE DISEASES
Psoriasis (LEAD INDICATION) $34 B Oral, safer, not Ph2 2025
SFA-002
Mild to Moderate RA $ 9B immunosuppressive
ONCOLOGY
Prevent Progression of
SFA-001 Liver cancer (HCC) Orphan Drug $ 6B
Disease
SFA-001N NASH/MASH $ 20 B Treatment Ph1 2025
Adjuvant to Prevent
72-100% of Treated
SFA-005 Adjuvant for CAR-T Cytokine Storm Cytokine Storm in CAR-T
Patients
Therapy
SFA-009 Pancreatic Cancer $3 B Adjuvant Ph1 2025

Prevent Progression of
SFA-001
Fibrosis $12 B Disease
DERMATOLOGY
12,000 Patients
SFA-003 Bullous Pemphigoid (rare Disease) Therapeutic
Rare Disease
OPTHALMOLOGY
SFA-004 Uveitis $500 M Therapeutic
COVID-19
Cytokine Storm Syndrome/Long Covid 4 M Patients
SFA-006 ARDs 10 M Patients Prevention & Treatment

SFA’S POTENTIAL MARKETS EXCEED $100 BILLION


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© 2024 SFA Therapeutics

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