Viridian Therapeutics : REVEAL-2 Phase 3 Topline Results (Presentation)

Published: 2026-05-05 10:57:08 ET VRDN

Published on 05/05/2026 at 10:57 am EDT

May 5, 2026

Introduction

Steve Mahoney

President & Chief Executive Officer

Chief Medical Officer

REVEAL-2 Phase 3 Topline Results Radhika Tripuraneni, MD

Closing Remarks

Steve Mahoney

President & Chief Executive Officer

Analyst Q&A

Steve Mahoney, President & Chief Executive Officer Radhika Tripuraneni, MD, Chief Medical Officer Shan Wu, Ph.D., Chief Business Officer

Tony Casciano, Chief Commercial Officer

Elegrobart

Veligrotug

Steroids/Surgery

Teprotumumab

First approved targeted therapy for TED

8 IV infusions

Next-gen anti-IGF-1R: Breakthrough Therapy Designation & Priority Review from U.S. FDA

5 IV infusions

Potential to be

the first subcutaneous autoinjector in TED

Q4W or Q8W

self-administered autoinjector1

Today PDUFA Target June 30, 2026 Anticipated Q1 2027 BLA

Veligrotug and elegrobart are investigational products that have not been approved by any regulatory authority; the safety and efficacy have not been established.

4 1 Planned product profile with commercial autoinjector format.

BLA = Biologics License Application, IGF-1R = insulin-like growth factor-1 receptor, IV = intravenous, Q4W = every 4 weeks, Q8W = every 8 weeks, SC = subcutaneous, TED = thyroid eye disease.

Topline data today

Achieved primary endpoint with high statistical significance

Clinically meaningful outcomes on multiple secondary endpoints, across both Q4W and Q8W doses

Rapid onset of treatment effect

Generally well-tolerated

5 Source: Viridian REVEAL-1 week 24 topline data on file (interim topline database lock).

BLA = Biologics License Application, Q4W = every 4 weeks, Q8W = every 8 weeks, TED = thyroid eye disease.

Achieved the primary endpoint with high statistical significance (p < 0.0001), with IV-like proptosis response

50% of Q4W and 54% of Q8W achieved a proptosis response vs 15% placebo at week 24 (p < 0.0001 for both arms)

Meaningful benefit on diplopia

61% of Q4W elegrobart achieved diplopia response vs 38% placebo at week 24 (p = 0.0118)

44% of Q4W elegrobart achieved diplopia complete resolution vs 25% placebo at week 24 (p = 0.0295)

Generally well tolerated in both dose groups, with low rates of hearing impairment through week 24

Elegrobart is the first & only subcutaneous program

with positive data in a pivotal chronic TED trial

Source: Viridian REVEAL-2 week 24 topline data on file (interim topline database lock).

6 P-values below 0.025 are statistically significant.

AE = adverse event, IV = intravenous, Q4W = every 4 weeks, Q8W = every 8 weeks, TED = thyroid eye disease.

Treatment Phase

(20 weeks treatment with primary endpoint at 24 weeks)

Key Inclusion Criteria

Any CAS (0-7)

Onset of TED symptoms

>15 months

Treatment Arms

(1:1:1)

Elegrobart Q4W1

Elegrobart Q8W1, 2

D11 W4 W8 W12 W16 W20

W24

Primary Endpoint Analysis

Primary efficacy endpoint:

Proptosis responder rate in Q4W arm

Key secondary endpoints:

Proptosis responder rate

Follow-up through W52

Additional efficacy & safety

follow-up at:

Week 36

Proptosis of ≥3 mm

Placebo

Key:

Elegrobart Placebo 300 mg

in Q8W arm

Proptosis mean change from baseline

Diplopia responder rate

Diplopia complete resolution rate

Week 52

7 1 600 mg loading dose given as two 300 mg injections; 2 Placebo injections administered at alternating study visits to maintain study masking across arms. D = day, mm = millimeter, Q4W = every 4 weeks, Q8W = every 8 weeks, TED = thyroid eye disease, W = week.

Randomized Patients

(n = 204)

Elegrobart Q4W

(n = 70)

Elegrobart Q8W

(n = 68)

Placebo

(n = 66)

Discontinued

3 withdrawal of consent

2 TEAEs

1 failure to follow protocol

1 lost to follow-up

Discontinued

1 withdrawal of consent

2 TEAEs

2 failure to follow protocol

1 lost to follow-up

Discontinued

2 withdrawal of consent

1 TEAE

1 failure to follow protocol

Completed Randomized Treatment

(n = 63)

Completed Randomized Treatment

(n = 62)

Completed Randomized Treatment

(n = 62)

8 Source: Viridian REVEAL-2 week 24 topline data on file (interim topline database lock). Q4W = every 4 weeks, Q8W = every 8 weeks, TEAE = treatment-emergent adverse event.

Elegrobart Q4W

(n = 70)

Elegrobart Q8W

(n = 68)

Placebo

(n = 66)

Participant Demographics

Age in years, mean (SD)

50.1 (11.3)

52.0 (11.2)

53.3 (11.2)

Female sex, n (%)

60 (86%)

57 (84%)

53 (80%)

White race, n (%)

54 (77%)

52 (76%)

51 (77%)

Disease Characteristics

Months since TED onset, mean (SD)

78.9 (73.4)

75.0 (72.1)

95.8 (108.6)

Baseline proptosis (mm), mean (SD)1

22.7 (2.9)

22.6 (2.9)

22.7 (2.7)

Baseline CAS, mean (SD)

2.7 (1.7)

3.0 (1.6)

2.8 (1.7)

Baseline CAS ≤1, n (%)

17 (24.3)

15 (22.1)

16 (24.2)

Baseline CAS ≥3, n (%)

38 (54.3)

43 (63.2)

34 (51.5)

Participants with diplopia, n (%)

47 (67%)

54 (79%)

47 (71%)

Diplopia (Gorman Score), mean (SD)2

1.8 (0.7)

1.9 (0.7)

1.8 (0.7)

Source: Viridian REVEAL-2 week 24 topline data on file (interim topline database lock).

Note: all proptosis & CAS reported values and endpoints in the data analysis are based on study eye (defined as eye with greater proptosis at baseline).

9 1 Measured by exophthalmometry, 2 Of patients with diplopia at baseline.

CAS = clinical activity score, mm = millimeter, Q4W = every 4 weeks, Q8W = every 8 weeks, SD = standard deviation, TED = thyroid eye disease.

Elegrobart Q4W

(n = 70)

Elegrobart Q8W

(n = 68)

Placebo

(n = 66)

-0.52 mm

-2.08 mm

(p < 0.0001)

-1.88 mm

(p < 0.0001)

Proptosis mean change from baseline1

15%

54%

(p < 0.0001)

47%

(p < 0.0001)

EMA Primary Endpoint

Overall responder rate (ORR)3

15%

54%

(p < 0.0001)

50%

(p < 0.0001)

FDA Primary Endpoint

Proptosis responder rate (PRR)1,2

Proptosis

Diplopia responder rate4

61%

(p = 0.0118)

55%

(p = 0.0419)

38%

Diplopia

Diplopia complete resolution5

44%

(p = 0.0295)

36%

(p = 0.1304)

25%

Source: Viridian REVEAL-2 week 24 topline data on file (interim topline database lock). P-values below 0.025 are statistically significant.

1 Measured by exophthalmometry, 2 Participants with ≥2 mm reduction in proptosis from baseline in study eye, without deterioration in fellow eye (≥2 mm increase), 3 Participants with both proptosis and CAS response; CAS response defined as no worsening in CAS from baseline in study eye, without deterioration in fellow eye (≥2-point increase), 4 Participants with reduction of ≥1 on Gorman Score at week 24, among patients with diplopia at baseline (Gorman Score >0),5 Participants with diplopia at baseline and a score of 0 at week 24.

CAS = clinical activity score, mm = millimeter, Q4W = every 4 weeks, Q8W = every 8 weeks.

Proptosis Responder Rate - Q4W Proptosis Responder Rate - Q8W

100

Primary endpoint: p < 0.0001

100

Key secondary endpoint:

p < 0.0001

Proptosis Responder Rate (%)

22%

34%

42%

41%

50%

Proptosis Responder Rate (%)

40 30%

36%

38%

44%

54%

6% 9%

0 5%

11%

19%

18%

15%

16%

0 6%

9% 11%

19% 18% 15%

Baseline

Week 4

Week 8

Week 12

Week 16

Week 20

Week 24

Baseline Week 4 Week 8 Week 12 Week 16

Week 20

Week 24

Analysis Visits

Placebo Elegrobart Q4W

Analysis Visits

Placebo Elegrobart Q8W

Source: Viridian REVEAL-2 week 24 topline data on file (interim topline database lock). PRR at time points prior to week 24 were prespecified exploratory endpoints.

11 P-values below 0.025 at week 24 are statistically significant. Q4W = every 4 weeks, Q8W = every 8 weeks.

Mean Change from Baseline - Q4W Mean Change from Baseline - Q8W

0 -0.27

-0.56

-0.61 -0.68 -0.65

Key secondary endpoint:

p < 0.0001

Proptosis Mean Reduction (mm)

-0.52

0 -0.27

-0.56 -0.61

-0.68 -0.65

Key secondary endpoint:

p < 0.0001

-0.52

Proptosis Mean Reduction (mm)

-0.63

-1

-1 -0.82

-1.10

-2

-1.44

-1.66 -1.79

-1.88

-1.26

-2

-1.45

-1.77 -1.84

-2.08

-3

Baseline Week 4 Week 8 Week 12 Week 16 Week 20 Week 24

-3

Baseline Week 4 Week 8 Week 12 Week 16 Week 20 Week 24

Analysis Visits

Placebo Elegrobart Q4W

Analysis Visits

Placebo Elegrobart Q8W

Source: Viridian REVEAL-2 week 24 topline data on file (interim topline database lock).

Proptosis mean change from baseline at time points prior to week 24 were prespecified exploratory endpoints.

12 P-values below 0.025 at week 24 are statistically significant. mm = millimeter, Q4W = every 4 weeks, Q8W = every 8 weeks.

Diplopia Responder Rate - Q4W Diplopia Complete Resolution - Q4W

100

Key secondary endpoint:

p = 0.0118

100

Key secondary endpoint:

p = 0.0295

Diplopia Responder Rate (%)

21%

32%

42%

49%

58%

Diplopia Resolution Rate (%)

61%

21%

25% 27%

38%

44%

16%

23%

32% 31%

36% 38%

20 13%

0 13%

17% 20%

23% 26% 25%

Baseline Week 4 Week 8 Week 12 Week 16 Week 20 Week 24 Baseline Week 4 Week 8 Week 12 Week 16 Week 20 Week 24

Analysis Visits

Placebo Elegrobart Q4W

Analysis Visits

Placebo Elegrobart Q4W

Source: Viridian REVEAL-2 week 24 topline data on file (interim topline database lock).

Diplopia responder rate and diplopia complete resolution at time points prior to week 24 were prespecified exploratory endpoints.

13 P-values below 0.025 at week 24 are statistically significant.

Q4W = every 4 weeks, Q8W = every 8 weeks, TED = thyroid eye disease.

Key efficacy endpoints in subgroup of patients with

low CAS (CAS ≤ 1) at baseline

Proptosis

Diplopia (Q4W: n=10; Q8W: n=11;

placebo: n=10)

Overall Response

Same CAS inclusion criteria as teprotumumab chronic TED phase 4 study1

Proptosis responder rate (PRR)2

Proptosis mean change from baseline2

Diplopia responder rate

Diplopia complete resolution

Overall responder rate (ORR)

Elegrobart Q4W

(n = 17)

Elegrobart Q8W

(n = 15)

Placebo

(n = 16)

54%

55%

(p = 0.0002)

(p = 0.0004)

-2.07 mm

-2.31 mm

(p = 0.0002)

(p < 0.0001)

57%

73%

(p = 0.1057)

(p = 0.0153)

33%

46%

(p = 0.0497)

(p = 0.0067)

42%

54%

(p = 0.0063)

(p = 0.0001)

-0.05 mm

30%

10%

Elegrobart demonstrated consistent, IV-like clinical activity in chronic TED patients regardless of baseline disease activity, in the largest and broadest TED phase 3 study completed to date

Source: Viridian REVEAL-2 week 24 topline data on file (interim topline database lock).

CAS subgroup analyses were prespecified exploratory endpoints. P-values below 0.025 are nominally significant.

14 1 Douglas RS et al., J Clin Endocrinol Metab. 2023; 109(1):25-35, 2 Measured by exophthalmometry.

CAS = clinical activity score, mm = millimeter, Q4W = every 4 weeks, Q8W = every 8 weeks, TED = thyroid eye disease.

Elegrobart Q4W

N=70

n (%)

Elegrobart Q8W

N=68

n (%)

Placebo N=66 n (%)

Participants with any treatment-emergent adverse event (TEAE)

55 (79%) 56 (82%) 44 (67%)

Participants with any serious AE (SAE) 3 (4%) 1 (1%) 0

Participants with any treatment-related TEAE 39 (56%) 39 (57%) 22 (33%)

Participants with any treatment-related SAE 0 0 0

Vast majority of TEAEs in both treatment arms were mild

No treatment-related SAEs

91% of elegrobart-treated patients completed full course of treatment

3 treatment-related TEAE discontinuations

- 1 in elegrobart Q4W arm1 & 2 in elegrobart Q8W arm2

Source: Viridian REVEAL-2 week 24 topline data on file (interim topline database lock).

1 1 treatment-related TEAE discontinuation in Q4W arm: Gr2 hyperglycemia & Gr2 muscle spasms; 2 2 treatment-related TEAE discontinuations in Q8W arm: Gr1 tinnitus

15 (related; resolving) and Gr3 muscle spasms (foot cramps).

AE = adverse event, MedDRA= medical dictionary for regulatory activities, SAE = serious adverse event, TEAE = treatment-emergent adverse event, Gr = grade.

AEs occurring at ≥10% frequency in any arm

Elegrobart Q4W

N=70

n (%)

Elegrobart Q8W

N=68

n (%)

Placebo N=66 n (%)

Muscle spasms

15 (21%)

25 (37%)

7 (11%)

Injection site reactions (ISR)1,2

16 (23%)

16 (24%)

18 (27%)

Hyperglycemia1

12 (17%)

8 (12%)

1 (2%)

Headache

7 (10%)

9 (13%)

3 (5%)

Hearing impairment1,3

5 (7%)

8 (12%)

2 (3%)

Diarrhea

3 (4%)

9 (13%)

1 (2%)

Nasopharyngitis

3 (4%)

7 (10%)

4 (6%)

Alopecia

2 (3%)

7 (10%)

5 (8%)

Menstrual disorders1,4

11 / 30 (37%)

7 / 27 (26%)

2 / 24 (8%)

Source: Viridian REVEAL-2 week 24 topline data on file (interim topline database lock).

1 Includes multiple terms aggregated using standard sets of MedDRA terms; 2 All ISRs were mild (Grade 1) except for 4 moderate (Grade 2) (3 in Q8W arm & 1 in placebo arm); most

16 common ISR was erythema; 3 Among participants that experienced hearing impairment AEs, the majority reported tinnitus; 4 Reported as percentage of menstruating women AE = adverse event, MedDRA = medical dictionary for regulatory activities, Q4W = every 4 weeks, Q8W = every 8 weeks.

Achieved the primary endpoint with high statistical significance (p < 0.0001), with IV-like proptosis response

50% of Q4W and 54% of Q8W achieved a proptosis response vs 15% placebo at week 24 (p < 0.0001 for both arms)

Meaningful benefit on diplopia

61% of Q4W elegrobart achieved diplopia response vs 38% placebo at week 24 (p = 0.0118)

44% of Q4W elegrobart achieved diplopia complete resolution vs 25% placebo at week 24 (p = 0.0295)

Generally well tolerated in both dose groups, with low rates of hearing impairment through week 24

Elegrobart is the first & only subcutaneous program

with positive data in a pivotal chronic TED trial

Source: Viridian REVEAL-2 week 24 topline data on file (interim topline database lock).

17 P-values below 0.025 are statistically significant.

AE = adverse event, IGF-1R = insulin-like growth factor-1 receptor, PRR = proptosis responder rate, Q4W = every 4 weeks, Q8W = every 8 weeks, TED = thyroid eye disease.

Only SC program with positive data in both active and chronic TED pivotal clinical trials

Elegrobart's two pivotal trials met their primary and multiple secondary endpoints, and elegrobart was generally well-tolerated

Potential to be the first subcutaneous autoinjector in TED

Planned simple, one-step autoinjector with each dose delivered in just seconds

Full treatment course as few as 3 doses

Potential to be treatment-of-choice for TED patients

Compelling proptosis & diplopia benefit with the potential to be the most convenient treatment in TED

Uniquely positioned to expand the

TED market

Anticipated to attract new patients, underserved by today's therapies, with a simple, convenient anti-IGF-1R, planned for at-home self-administration

18 Source: Viridian REVEAL-1 & REVEAL-2 week 24 topline data on file (interim topline database lock).

BLA = Biologics License Application, IGF-1R = insulin-like growth factor-1 receptor, SC = subcutaneous, TED = thyroid eye disease.

Veligrotug

Elegrobart Q8W

Granted Breakthrough Therapy Designation & Priority Review from U.S. FDA

Potential to be the first subcutaneous autoinjector in TED, providing a simple, infrequent, at-home treatment

12-Week IV Regimen Self-Administered Autoinjector1

PDUFA target date: June 30, 2026 BLA submission: anticipated Q1 2027

1 Planned product profile with commercial autoinjector format.

19 BLA = Biologics License Application, FDA = Food and Drug Administration, IV = intravenous, PDUFA = Prescription Drug User Fee Act, Q4W = every 4 weeks, Q8W = every 8 weeks, TED = thyroid eye disease

Thank you to the TED community: patients, advocates, investigators, research staff, and partners who made this trial a success

Disclaimer

Viridian Therapeutics Inc. published this content on May 05, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 05, 2026 at 14:56 UTC.