Viridian Therapeutics : Corporate Presentation (Presentation)
VRDN
Corporate Presentation
February 2025
Viridian is building upon proven first market entrants to develop differentiated next-generation products
First-generation product establishes significant opportunity for next-generationstrategy
Identify market opportunities with clear remaining unmet need
Determine key areas of potential product differentiation
Engineer potential best-in-class antibodies and therapeutic proteins
Rapidly advance programs to patients
3
CONFIDENTIAL
Differentiated pipeline: TED portfolio moving towards commercial and FcRn inhibitor portfolio moving towards the clinic
Thyroid Eye Disease (anti-IGF-1R) Portfolio
FcRn-
Targeting
Autoimmune
Portfolio
DISCOVERY PRECLINICAL PHASE 1 PHASE 2 PHASE 3STATUS
Veligrotug
Reported positive
Intravenous
topline data
VRDN-003
Pivotal trials
Subcutaneous
ongoing
VRDN-006
Phase 1 study
FcRn-targeting
ongoing
Fc fragment
VRDN-008
Preclinical
Bispecific, extended
studies ongoing
half-life FcRn inhibitor
4
Fc = fragment crystallizable, FcRn = neonatal Fc receptor, IGF-1R = insulin-like growth factor-1 receptor, TED = thyroid eye disease.
CONFIDENTIAL
Viridian is well positioned to deliver significant catalysts
Anticipated Catalysts
Veligrotug
• Positive THRIVE and THRIVE-2 topline data in active and chronic
TED showed a differentiated clinical profile1
Intravenous
•
Well positioned to become the IV treatment-of-choice in TED
BLA submission: 2H 2025
EU MAA submission: 1H 2026
PDUFA date & U.S. launch: 2H 2026
VRDN-003
•
REVEAL-1 and REVEAL-2 enrolling and dosing patients
Subcutaneous
FcRn
• VRDN-006 healthy volunteer data expected in Q3 2025
Portfolio
• VRDN-008 additional preclinical data expected in 2025
Financial
• $718M cash as of December 31, 2024
•
Runway into 2H 2027
Topline data for both trials: 1H 2026
BLA submission: Year-end2026
Healthy volunteer data: Q3 2025
Additional preclinical data: in 2025
IND submission: Year-end2025
Source: 1 Viridian THRIVE & THRIVE-2 data on file.
BLA = Biologics License Application, CAS = clinical activity score, EU = European Union, FcRn = neonatal Fc receptor, HV = healthy volunteer,
5 IgG = Immunoglobulin G, IND = Investigational New Drug, MAA = Marketing Authorization Application, NHP = non-human primate, PDUFA = Prescription Drug User Fee Act, TED = thyroid eye disease.
CONFIDENTIAL
Near-term anticipated clinical and regulatory catalysts offer potential to drive significant value
Thyroid Eye Disease (anti-IGF-1R)
Veligrotug
Intravenous
BLA
submission
2H 2025
EU MAA
Potential PDUFA
submission
date & launch
1H 2026
2H 2026
Portfolio
VRDN-003
Subcutaneous
Phase 3 topline data for
REVEAL-1 (active TED) & REVEAL-2 (chronic TED)
1H 2026
BLA
submission
YE 2026
2025
2026
FcRn-
Targeting
Autoimmune
Portfolio
VRDN-006
FcRn-targeting Fc fragment
VRDN-008
Bispecific, extended half-life FcRn inhibitor
IgG reduction
PoC in HVs
Q3 2025
Additional
preclinical data
2025
IND
submission
YE 2025
IgG reduction
PoC in HVs
2H 2026
BLA = Biologics License Application, Fc = fragment crystallizable, FcRn = neonatal Fc receptor, HV = healthy volunteers, IGF-1R = insulin-like growth factor-1
6 receptor, IgG = immunoglobulin G, IND = Investigational New Drug, MAA = Marketing Authorization Application, PoC = proof of concept, PDUFA = Prescription Drug User Fee Act, TED = thyroid eye disease.
CONFIDENTIAL
Viridian is building a leadership position in autoimmune disease
Revenue-Funded
Commercial
Growth
Transition
BLA and MAA
2027+
Submission &
Commercial Readiness
2026
VRDN-003
v
BLA
Launch**
Submission*
Active & Chronic TED
Veligrotug v
Advance Potential
BLA
EU MAA
Launch**
Best-in-Class
Submission*
Submission*
Active & Chronic TED
FcRn Portfolio
2025
Continue to Advance and Expand Pipeline
FcRn Portfolio, New Programs
7 * Planned; ** If approved.
BLA = Biologics License Application, FcRn = neonatal Fc receptor, MAA = Marketing Authorization Application, TED = thyroid eye disease.
CONFIDENTIAL
Thyroid Eye Disease (TED) Portfolio
8
TED is an autoimmune condition characterized by inflammation, growth, and damage to tissues around and behind the eyes
Autoantibodies trigger IGF-1R/TSHR pathway1
Normal Eye Anatomy
Thyroid Eye Disease (TED)
Bulging
Eyes
Heterogeneous autoimmune disease with clinical signs and symptoms that can vary or modulate following onset, in some cases for the rest of a patient's life2,3
Main signs include proptosis (eye bulging), redness, swelling, diplopia (double vision), and lid retraction2,3
Severe cases can cause sight-threatening optic nerve compression4
An estimated 190K people in the US alone have moderate to severe TED5
Optic Nerve
Enlargement of extraocular muscles
People living with TED experience proptosis, redness,
swelling, diplopia, and lid retraction
Sources: 1 George A et al. Front Endocrinol (Lausanne). 2021;11:629925., 2 Smith TJ et al. NEJM. 2016;375(16):1552-1565., 3 Bahn RS. NEJM. 2010;
362(8): 726-738., 4 Bartley GB et al. Am J Ophthalmol 1996;121(3):284-290., 5 Viridian-sponsored market research, includes active and chronic TED.
9 TED patient images are from Bahn RS. NEJM. 2010; 362(8): 726-738. Copyright © (2010) Massachusetts Medical Society. Reprinted with permission from Massachusetts Medical Society.
IGF-1R = insulin-growth factor 1 receptor, TED = thyroid eye disease, TSHR = thyroid stimulating hormone receptor.
CONFIDENTIAL
Viridian is developing an IGF-1R antibody portfolio with the potential to transform the treatment for people living with TED
Veligrotug
Teprotumumab
VRDN-003
Steroids/ Surgery
First
approved
targeted therapy
for TED
8 IV infusions
THRIVE/THRIVE-2 topline data show differentiated clinical profile1
in a new start market
Subcutaneous and potential
best-in-class therapy
Q8W or Q4W dosing;
self-administered
autoinjector planned
REVEAL-1 and REVEAL-2 currently dosing patients; topline data in 1H 2026
Today
Planned 2025 BLA and 2026 EU MAA
Planned 2026 BLA
Source: 1 Viridian THRIVE & THRIVE-2 data on file.
10 BLA = Biologics License Application, IGF-1R = insulin-like growth factor-1 receptor, IV = intravenous, MAA = Marketing Authorization Application, Q4W = every 4 weeks, Q8W = every 8 weeks, TED = thyroid eye disease.
CONFIDENTIAL
Disclaimer
Viridian Therapeutics Inc. published this content on February 27, 2025, and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on February 27, 2025 at 12:21:25.629.