Professional Documents
Culture Documents
of autoimmune disease TM
Corporate Presentation
December 2022
Executive Summary
Disease modifying, multi-target therapeutics for oral treatment of chronic inflammatory disease
• Patented drugs that act on multiple therapeutic pathways, including NF-kβ and
cytokine signaling, multi-channel cascades affecting gene expression, and Treg
differentiation
2
PASI: Psoriasis Area and Severity Index; IGA: Investigator's Global Assessment
Leadership Team
Experienced team with over 40 drugs developed, ten prior exits, and over $600M in prior raises
3
Advisory Team
Scientific and business advisors with deep expertise in psoriasis and other disease markets
Scientific Advisors Business Advisors
Sylvia Hsu, MD Professor and Chair, Dermatology, Temple University Craig Kenesky, JD, PhD IP Counsel, Wilson Sonsini Goodrich
& Rosati
Senior Consultant at Princeton Dermatology Corporate Counsel, DLA-Piper
Andrew Gilbert, JD
Daniel Sauder, MD Associates, Prior Chair, Dept. Dermatology at John
Hopkins and University of Toronto
Jordan Warshafsky, MBA Business/HR Advisor, Ashton Tweed
Director, Professor of Dermatology and
Epidemiology, Vice Chair of Clinical Research,
Joel Gelfand, MD, MSCE Medical Director of Clinical Studies Unit in the Angela Lynch, PhD Scientific Advisor, Toxicology
Department of Dermatology, UPenn
Raxit Mehta, M.C.E Formulation Advisor
Chris Gallen, MD, PhD CEO, WEX Pharmaceuticals
CMO, ADC Therapeutics; Chair, Board of MaliHealth Kate Hermans, MBA Commercialization Planning
Joseph Camardo, MD Member of Scientific Advisory Committee at DNDi
Director, Vice Chair, and Chief, Pittsburgh Liver Sri Sriadibhatla, PhD Ben Franklin Technology Partners,
Satdarshan Monga, MD Research Center, Division of Experimental Pathology, Board Observer
University of Pittsburgh
Oncology (HCC)
FDA Orphan Drug Designation for HCC
NASH (fibrosis)
Phase 1b: IND filed for upcoming clinical trial in NASH
AML: Acute Myeloid Leukemia; CLL: Chronic Lymphocytic Leukemia; HCC: Hepatocellular Carcinoma; NASH: Nonalcoholic Steatohepatitis 5
Limitations of Current Autoimmune Therapies
Marketed autoimmune therapies are limited by single / dual target approach and safety
Mono / Dual Current therapies are mono or dual targeted, while autoimmune
Targeted diseases (including psoriasis) involve multiple targets
6
Overview of Lead Program: SFA-002
Potential first-in-class oral therapy with compelling preliminary clinical results in a Phase 1a
Oral Pill
small molecule with proprietary formulation
Immunomodulator
that returns the immune system to normal
by affecting multiple psoriasis targets
Disease-Modifying
targets the root cause of autoimmune disease
and has the potential to treat multiple
autoimmune diseases
7
SFA-002’s MOA Overview in Psoriasis
SFA-002 affects multiple cellular signaling pathways that are critical in the pathogenesis of psoriasis
Mechanisms of Action
8
Signalling Pathways are Well-Understood
SFA Technology modulates multiple cellular signaling pathways involved in autoimmune diseases
9
SFA-002’s Compelling Preliminary Clinical Results
Phase 1a data in psoriasis patients strongly validates SFA’s novel oral and multi-targeted approach
✓ No adverse events
✓ Durable response
Off Treatment
>1 Year • Patient remains off
treatment for >1 year
with no return of
symptoms
PASI: Psoriasis Area and Severity Index 11
Compelling Clinical Results in Difficult to Treat Areas
Durable response achieved in patient with hand and scalp psoriasis
✓ No adverse events
✓ Durable response
SFA-002 Treatment
• Patient remains off
at 6 Months
treatment for >1.5 years with
no return of symptoms
Caucasian/
2 48 M None Alcohol Plaque Psoriasis Severe 15 28 days 80 None
Ukraine
Hypertension,
Caucasian Losap for
3 72 M Stage 3 (8 yrs); Plaque Psoriasis Mild 15 31 days 80 None
Ukraine hypertension
Asthma (12 yrs)
13
Phase 1b Clinical Trial Design
Two combinations will be evaluated for safety and efficacy in 30 subjects
Injectable
PASI 75
Oral
Brands / Assets
Stelara
PASI 90-100
BAT2206
AK101
Humira
Biosimilars Remicade
Enbrel
DMB-3116 Cosentyx Skyrizi
ABP-654 SCT-630 Siliq Tremfaya
FYB-202 Taltz
SB-17 Biosimilars: Otezla; Deucravaci- AUR-101; IBI-112 ABY-035
CT-P43 ABP-501 608* Orismilast* tinib (BMS); cedirogant- Mirikizu- AK-111
AVT-04 301s BCD-085 Hemay-005 NDI-034858 (ABBV-157) Ilumya Cimzia CF-101 Jaktinib KBL-697 SCD-044 mab SHR-1314 Bimzelx SFA-002
PEG-TNF-⍺
TNF-⍺
IL-12, IL-23
PDE-4
IL-23A
IL-17F, IL-17A
TYK2
A3AR agonist
S1P1a
IL-23A
IL-17A
JAK 1/2
Lactobacillus
RORγt
gasseri
⍺, IFN-γ
SFA-002 is the only oral immunomodulatory therapy with the potential to achieve PASI 90–100
15
SFA-002’s Strong Multi-Target Engagement
SFA-002 demonstrated significant response in human ex vivo skin psoriasis model
TNF-α IL-23
• SFA-002 demonstrated
better responses compared
to Otezla
• Surprisingly, Otezla
significantly upregulated
TNF-α in comparison to
untreated control
16
SFA-002’s Strong Improvement in Murine Psoriasis Model
SFA-002 significantly decreased psoriasis severity in the murine IMQ-psoriasis model
17
SFA-002 Downregulated TNF-α in the LPS Murine Model
SFA-002 rapidly reduced plasma TNF-α within 26 hours in the LPS animal model of inflammation
Plasma TNF-α
Plasma TNF-α measured by commercially available ELISA. Data are mean (+/ -) SEM and analyzed by one-way
ANOVA with fisher’s uncorrected LSD test (*P<0.05, ***P<0.001, Compared to VEH/LPS group, n=8/group) 18
Intellectual Property and CMC
Robust patent portfolio including composition of matter and methods of use
19
Key Investors and Collaborators
Industry validating investors and academic partnerships
ASYMMETRY
20
SFA-002 Development Plan and Use of Proceeds
SFA is seeking a $25 M raise to accelerate the clinical development of SFA-002
Phase 2 Study2 $3 M
Formulation Optimization $1 M
Other Costs (i.e., IP protection, milestone payments, reserves, Phase 3 estimate) $17 M
22
Appendix
SFA-001 Delays Onset and Progression of Liver Cancer
HBxTg Transgenic Mice Treated with SFA001 Showed Delayed Onset and Progression of HCC
In mice bred with the gene for liver cancer, 50% of the treated
mice developed no tumors, the other 50% treated mice had
fewer and smaller tumors
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SFA-001 Reduces Tumor Growth and Cancer Cell Viability
SFA-001 Blocks Human Xenograft Liver Cancer Growth and Reduced Viability of Cancer Cells
SFA001 Treated Mouse Control Mouse
A B • Immunocompromised nude mice
were subcutaneously injected with
human liver cancer cells (Huh7X)