ALMS
Published on 05/14/2026 at 04:10 pm EDT
1
Alumis' Next-Gen TYK2 Inhibitors: Two Pipelines-in-a-Pill
Positive Psoriasis Phase 3
Envudeucitinib delivered highly significant efficacy with leading PASI 100 responses and early and robust improvements in skin clearance, quality of life, and symptoms
Significant Near-term Value
Global opportunity for Psoriasis (~$40B) and Lupus (~$11B) expected by 20301
High efficacy orals expected to drive market growth
Broader TYK2 Opportunity
Significant market opportunity (projected $180B+2) across many indications with potential to be addressed by TYK2 molecules. Envudeucitinib and A-005 provide two pipelines-in-a-pill
Differentiated TYK2i's
Envudeucitinib and A-005 are precision engineered for 24-hour maximal target inhibition
Maximal inhibition translates to leading efficacy with balanced safety and tolerability
2026 Anticipated Milestones
Envudeucitinib Psoriasis: Additional data and NDA filing
Envudeucitinib SLE: Potentially pivotal Phase 2b SLE topline data
TYK2 Franchise Strategy (Envudeucitinib and A-005): Evaluation of additional indications
Positioned to Unlock the Full Potential of TYK2i Mechanism
Hypothesis validated: maximal target engagement translates into higher clinical efficacy
Power of TYK2i
Human Genetics: TYK2 loss-of-function variants protect against immune mediated disorders
Known Mechanism: TYK2 is an upstream mediator of immune disease (IL-23/IL-17, IL-12, Type I Interferon)
Clinically Validated: Efficacy in plaque psoriasis, psoriatic arthritis, CLE and SLE
What Matters
Sustained and maximal TYK2 inhibition
High kinome selectivity for TYK2
Safety and tolerability
Alumis Opportunity
Breadth of IL-23/IL-17 and Type I IFN-driven diseases
Peripheral and CNS indications
Portfolio optimization with multiple molecules and formulations
Late-stage Pipeline with Multiple Near-term Anticipated Milestones
Our pathway to patients
A-005
Neuroinflammation
Other
IRF5/Additional Targets Undisclosed
Systemic Lupus Erythematosus (SLE)
Plaque Psoriasis
Envudeucitinib
TYK2i
Program
Indication
Preclinical
Phase 1
Phase 2
Phase 3
Lonigutamab
Exploring strategic alternatives
Key Achievements and Anticipated Milestones for 2026
✓
✓
✓
1Q26
1Q26
1H26
2Q26
3Q26
2H26
2H26
2H26 Q426
Envu - PsO Phase 3 Topline Data for 16- and 24-week Endpoints Envu - PsO Phase 3 Additional Data Presented at AAD Lonigutamab - Completion of Strategic Review
TYK2 Franchise Development Strategy (Envu and A-005) - Evaluation of Additional Indications Envu - SLE Phase 2b Topline Data
Envu - PsO ONWARD3 Topline Data Envu - PsO Phase 2 Two-Year Safety Data
Phase 1 trial Initiation - next clinical candidate (new target) Envu - PsO NDA Filing
Significant Disease Burden Remains in Psoriasis
Many patients remain untreated or undertreated, despite available treatments
Significant Unmet Market Opportunity Driven by Persistent Disease, Undertreatment, and High Therapy Discontinuation
Biologic
ies, social Lower Efficacy Oral
e limited
>8M Diagnosed Topicals
tients are U.S. Patients1
y lead to Untreated, Light
Therapy
Persistent Symptoms: Many patients continue to experience itch, pain, and visible skin lesions despite current therapies
Quality-of-Life Impact: Psoriasis still significantly affects daily activit interactions, and emotional well-being
Inadequate Therapies: Most patients receive treatments that provid benefit and do not address the systemic nature of the disease
Undertreatment with Low-Efficacy Options: Fewer than 10% of pa currently treated with high efficacy drugs including biologics2
High Therapy Discontinuation: Lack of efficacy and poor tolerabilit two-thirds of patients discontinuing oral therapies within 12 months3
Comorbidities and Long-Term Risk: Psoriasis patients face elevated risks for arthritis, cardiovascular disease, and other systemic complications
Majority of Psoriasis Patients Remain Untreated or Undertreated
Injectable
National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed December 2025.
IQVIA Analysis, Stable and eligible newly diagnosed patients from April 2021- March 2022 utilized for longitudinal analysis; all patients have at least 24M of look forward post-Dx.
Multiple Entry Points Available in Growing Psoriasis Market
High-efficacy orals well-positioned to capture market share in $40B projected market by 20301
Estimated Market Share by Brand and MOA2
Low Efficacy Oral
IL-17
TNF
IL-23
Multiple Market Dynamics Drive Opportunity for Oral and Differentiated Therapies
No single Brand or Mechanism of Action has dominant market share
Otezla is the most prescribed systemic therapy
High switching rates
44% of systemically treated patients switched to a new therapy in the last 12 months3
Access barriers
High cost, payor restrictions, administrative hurdles limit biologic uptake, leaving space for accessible alternatives
Low brand loyalty
HCPs prefer having multiple options; frequently switch/rotate therapies
Source: Evaluate Pharma as of December 2025.
Source: Veeva Claims data from 1/1/2025 to 6/30/25. Oral: apremilast, deucravacitinib; TNF: certolizumab, etanercept, Infliximab; IL-17: ixekizumab, secukinumab, bimekizuma, brodalumab; IL23:
Key Drivers of Use in Psoriasis Treatment
HCP Treatment Goals:
1
2
PASI 90/PASI 100 outcomes
Low AEs
3
Itch relief
HCP Preferences Simplicity
Easy regimens, minimal monitoring, and
reduced administrative steps
Treating harder, earlier
Recognize that faster, more complete clearance reduces long-term disease and quality-of-life impact
We are definitely lacking orals because whatever we have here in terms of the orals, the efficacy is not there yet.
- Derm2
Patient Treatment Goals:
1
2
Skin clearance
Symptom relief including itch
3
Safety
Patient Preferences Orals
75% of patients choose an oral over a
biologic1
Convenience
Fit with routine and lifestyle, favor flexible dosing without food restrictions
I'm tired. Tired of the itching, the burning, the flaking - tired of how you (psoriasis) make me feel about my own skin. You've made me self-conscious in ways I never thought possible.
- Patient2
In Industry surveys: J&J Business Review Dec 2023 (survey of n=395 patients with moderate-to-severe psoriasis).
Internal company market research. 10
Envudeucitinib is a Next-Generation, Highly Selective Oral Allosteric TYK2 Inhibitor
Oral systemic therapy that addresses immune dysregulation at its source, delivering robust skin clearance and early symptom relief that impacts quality of life
Power of TYK2
Inhibiting TYK2, a central upstream regulator of multiple psoriasis pathways, blocks both IL-23 and IL-17 to address immune dysregulation
Envudeucitinib is precision engineered to deliver maximal 24-hour inhibition, enabling early and broad disease control1,2
1. Ucpinar S, et al. Clin Transl Sci. 2024;17(12):e70094. 2. Blauvelt A, et al. J Am Acad Dermatol. 2026;94(1):57-65.
Envudeucitinib is an investigational therapy not reviewed or approved by any regulatory agency. 11
Phase 3 Psoriasis Clinical Program: Well-Designed and Rapidly Executed
Two Phase 3 trials and LTE to evaluate efficacy & safety of envudeucitinib in moderate-to-severe plaque psoriasis
Treatment Period Maintenance LTE Open Label
Envudeucitinib, 40mg BID (N=420)
Envudeucitinib
Wk 16: Rollover to envudeucitinib
Placebo (N=210)
R
2:1:1
Apremilast, 30mg BID (N=210)
Randomization
N= 840
Week
BL 1
2 4 8 12
16 20
Primary End Point
24
End of Ph3
〉ONWARD1 and ONWARD2: 24-week duration, placebo and active comparator (apremilast) controlled
〉ONWARD3: Long-term extension (LTE) study, includes treatment withdrawal period starting at Week 24
* Reflects trial design; not actual enrollment figures. 12
ONWARD1 and ONWARD2 Phase 3 Data Update AAD March 2026
Broad and meaningful clinical benefits emerged early; QoL and itch improvements appeared before PASI 90 skin clearance
Envudeucitinib Delivered Early and Robust Improvements in Skin Clearance, with Meaningful Improvements in Psoriasis Symptom Relief and QoL
Leading PASI 100 skin clearance among oral plaque psoriasis therapies; consistent across ONWARD1 and 2
Compelling differentiation and rapid improvement in patient reported outcomes
Differentiated and attractive profile for physicians and patients
Envudeucitinib is an investigational therapy not reviewed or approved by any regulatory agency.
Note: the comparisons on this slide relate to retrospective post hoc cross-trial comparisons, which may not be directly comparable. Differences exist between trial designs and subject 13
characteristics, and caution should be exercised when comparing data across unrelated studies.
Envudeucitinib Demonstrated Reproducibility Between ONWARD1 and ONWARD2 and Consistency Across PASI 100 and sPGA-0 Responses
41.0% 39.5%
ONWARD1 ONWARD2
41.6% 40.6%
ONWARD1 ONWARD2
envudeucitinib envudeucitinib
Envudeucitinib: Leading PASI 100 Skin Clearance
41.0% 39.5%
41.5%
33.2%
42.3%
32.1%
ONWARD1 ONWARD2
envudeucitinib
ADVANCE1 ADVANCE2
icotrokinra
LATITUDE 3001LATITUDE 3002
zasocitinib
Envudeucitinib data presented from ONWARD 1 and ONWARD 2 trials (AAD 2026).
Icotrokinra data presented from ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 trials (Stein Gold L. et. al Lancet, 2025). Zasocitinib data presented from LATITUDE-PsO-3001 and LATITUDE-PsO-3002 (AAD 2026).
Note: The results of this retrospective post hoc cross-trial comparison may not be directly comparable. Differences exist between trial designs and subject characteristics, and caution
Envudeucitinib Resulted in Rapidly Increasing, Statistically Significant PASI 90 Response Rates vs Placebo and Apremilast
ONWARD1 ONWARD2
Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230)
Envudeucitinib 40 mg BID (n = 433) Placebo (n = 211)
PASI 90 Responders, % (95% CI)
100
80
Apremilast 30 mg BID (n = 223)
/Envudeucitinib 40 mg BID (n = 205)
***
100
PASI 90 Responders, % (95% CI)
80
Apremilast 30 mg BID (n = 215) /Envudeucitinib 40 mg BID (n = 185)
***
60
40 27.4
45.2
***
59.9
66.7 68.0
60
39.0
40
22.5
24.8
44.2
***
56.6
53.1
25.9
62.1
39.5
20 4.8
0.5 2.7
0.5 0.4
0.0
0
7.6
2.6
21.5
15.9
4.4 4.8
18.8
25.6
20 0.5 4.4
0.5 1.4
0.0 0.0
0
10.7
0.9
16.4 20.9
2.9 4.3
18.1
25.6
0 4 8 12 16 20 24
Week
0 4 8 12 16 20 24
Week
Intention-to-treat population. The 95% CIs and P-values of the treatment differences were based on the Cochran-Mantel-Haenszel test adjusted for stratification factors. Nonresponder imputation was applied for missing data. ***P<0.0001 vs placebo and apremilast.
Envudeucitinib Demonstrated Robust and Progressive Improvement in PASI 100 Response Rates Over Time
ONWARD1 ONWARD2
PASI 100 Responders, % (95% CI)
Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Envudeucitinib 40 mg BID (n = 433) Placebo (n = 211)
PASI 100 Responders, % (95% CI)
80 Apremilast 30 mg BID (n = 223)
/Envudeucitinib 40 mg BID (n = 205)
80 Apremilast 30 mg BID (n = 215) /Envudeucitinib 40 mg BID (n = 185)
60
40
20.4
***
29.4
36.3
60
***
41.0
40
21.2
***
27.7
34.7
***
39.5
18.4
20
0.0
0.0
0.0
0
0.9
0.4
0.0
8.1
2.7
0.0
3.6
4.0
0.4 0.9
5.0
5.0
13.7
8.5
20
0.0
0.2
0.7
0.0
0 0.0 0.0
9.3
2.3
0.5
5.2
1.0
7.9
0.9
13.0
11.3
6.0
0 4 8 12 16 20 24
Week
0 4 8 12 16 20 24
Week
Intention-to-treat population. The 95% CIs and P-values of the treatment differences were based on the Cochran-Mantel-Haenszel test adjusted for stratification factors. Nonresponder imputation was applied for missing data. ***P<0.0001 vs placebo and apremilast.
Rapid, Significant, and Sustained Scalp Psoriasis Improvement With Envudeucitinib
ONWARD1 ONWARD2
Envudeucitinib 40 mg BID (n = 274) Placebo (n = 135) Apremilast 30 mg BID (n = 150)
/Envudeucitinib 40 mg BID (n = 122)
Envudeucitinib 40 mg BID (n = 285) Placebo (n = 140) Apremilast 30 mg BID (n = 134)
/Envudeucitinib 40 mg BID (n = 125)
ss-PGA-0/1 Responders, % (95% CI)
100
80
60.9
69.1
*** ***
74.5 78.7 77.4
55.4 65.6
100
ss-PGA-0/1 Responders, % (95% CI)
80
54.6
*** ***
76.0 74.7
67.5 70.9
54.4 65.6
60
40
14.3
35.1
18.7
14.2
34.7
17.0
45.9 48.0
24.6 25.2
47.0 48.7
60
40
14.2
32.2
19.4
10.7
40.3
40.9 38.8
20.7
48.5
41.8
5.5
20 6.2
9.1
20 3.6
18.4
13.6
0
0 4 8 12 16 20 24
Week
0
0 4 8 12 16 20 24
Week
Intention-to-treat population. The 95% CIs and P-values of the treatment differences were based on the Cochran-Mantel-Haenszel test adjusted for stratification factors. Nonresponder imputation was applied for missing data. aIn patients with baseline ss-PGA ≥3. ***P<0.0001 vs placebo at Week 16 and apremilast at Week 24.
Benefits in Itch Reduction and Quality of Life Visible Before Skin Clearance
ONWARD1
ONWARD2
Envudeucitinib 40 mg BID
ITCH
DLQI-0/1
PASI 90
80
0 80
Envudeucitinib 40 mg BID
ITCH
DLQI-0/1
PASI 90
0
Responders, % (95% CI)
Itch Δ Baselinea (95% CI)
Responders, % (95% CI)
Itch Δ Baselinea (95% CI)
60 -2 60 -2
40 -4 40 -4
20 -6 20 -6
0 -8
0 4 8 12 16 20 24
Week
0 -8
0 4 8 12 16 20 24
Week
Intention-to-treat population. For DLQI and PASI 90, the 95% CIs and P-values of the treatment differences were based on the Cochran-Mantel-Haenszel test adjusted for stratification factors. Nonresponder imputation was applied for missing data. For itch, LSMs, CIs, and P-values are based on MMRM. aLSM change from baseline in worst pruritus NRS.
Envudeucitinib's Differentiated and Attractive Profile for Physicians and Patients
Leading and consistent PASI 100 skin clearance among oral plaque psoriasis therapies
Early onset of action; PASI 90 responses emerged as early as Week 4
Clear or almost clear scalp psoriasis as early as Week 4
Improvements across burdensome symptoms highlight early onset and broad clinical benefit
Rapid and profound improvements in Quality-of-life measures
Meaningful itch relief was apparent before PASI 90 skin clearance
•
Generally well tolerated through Week 24 in ONWARD trials; safety profile consistent with Phase 2 program
No clinically significant lab abnormalities observed
No TB reactivations
ONWARD3: Wk 48 results on LT efficacy & safety/tolerability, durability & maintenance
Additional special areas (palmoplantar, nails)
Biomarker analysis
Disclaimer
Alumis Inc. published this content on May 14, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 14, 2026 at 20:09 UTC.