Groowe Groowe BETA / Newsroom
⏱ News is delayed by 15 minutes. Sign in for real-time access. Sign in

Form 8-K

sec.gov

8-K — ALUMIS INC.

Accession: 0001104659-26-036386

Filed: 2026-03-30

Period: 2026-03-28

CIK: 0001847367

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tm269978d1_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (tm269978d1_ex99-1.htm)

EX-99.2 — EXHIBIT 99.2 (tm269978d1_ex99-2.htm)

GRAPHIC (tm269978d1_ex99-1img01.jpg)

GRAPHIC (tm269978d1_ex99-2img001.jpg)

GRAPHIC (tm269978d1_ex99-2img002.jpg)

GRAPHIC (tm269978d1_ex99-2img003.jpg)

GRAPHIC (tm269978d1_ex99-2img004.jpg)

GRAPHIC (tm269978d1_ex99-2img005.jpg)

GRAPHIC (tm269978d1_ex99-2img006.jpg)

GRAPHIC (tm269978d1_ex99-2img007.jpg)

GRAPHIC (tm269978d1_ex99-2img008.jpg)

GRAPHIC (tm269978d1_ex99-2img009.jpg)

GRAPHIC (tm269978d1_ex99-2img010.jpg)

GRAPHIC (tm269978d1_ex99-2img011.jpg)

GRAPHIC (tm269978d1_ex99-2img012.jpg)

GRAPHIC (tm269978d1_ex99-2img013.jpg)

GRAPHIC (tm269978d1_ex99-2img014.jpg)

GRAPHIC (tm269978d1_ex99-2img015.jpg)

GRAPHIC (tm269978d1_ex99-2img016.jpg)

GRAPHIC (tm269978d1_ex99-2img017.jpg)

GRAPHIC (tm269978d1_ex99-2img018.jpg)

GRAPHIC (tm269978d1_ex99-2img019.jpg)

GRAPHIC (tm269978d1_ex99-2img020.jpg)

GRAPHIC (tm269978d1_ex99-2img021.jpg)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K — FORM 8-K

8-K (Primary)

Filename: tm269978d1_8k.htm · Sequence: 1

false

0001847367

0001847367

2026-03-28

2026-03-28

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.

20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities

Exchange Act of 1934

Date of Report (Date of earliest event reported):

March 28, 2026

Alumis Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-42143

86-1771129

(State or other jurisdiction

of incorporation or organization)

(Commission

File Number)

(I.R.S. Employer

Identification Number)

280 East Grand Avenue

South San Francisco, California 94080

Registrant’s telephone number, including area code: (650) 231-6625

N/A

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under

any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities

Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange

Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under

the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under

the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b)

of the Act:

Title of each class

Trading

Symbol(s)

Name

of each exchange

on which registered

Common Stock, $0.0001 par value per share

ALMS

The Nasdaq Global Select Market

Indicate by check mark whether

the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule

12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company x

If an emerging growth company, indicate by check

mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting

standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 8.01 Other Events.

On March 28, 2026, Alumis

Inc. (the “Company” or “Alumis”) issued a press release titled “Alumis’ Envudeucitinib Delivers Early

and Robust Improvements in Skin Clearance, Quality of Life and Psoriasis Symptoms in Two Phase 3 Trials, Underscoring Its Potential as

a Leading Oral Therapy for Plaque Psoriasis”.

The Company is also filing

slides presented by the Company at a late-breaking oral presentation at the 2026 American Academy of Dermatology (AAD) Annual Meeting

on March 28, 2026.

Copies of the press

release and presentation are filed as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K (the

“Report”) and are incorporated by reference.

The information contained in the presentation is summary information that is intended to be considered in the context of the more complete

information included in the Company’s filings with the Securities and Exchange Commission (“SEC”) and other public announcements

that the Company has made and may make from time to time by press release or otherwise. The Company undertakes no duty or obligation to

update or revise the information contained in the presentation in this Report, although it may do so from time to time as its management

believes is appropriate. Any such update may be made through the filing of other reports or documents with the SEC.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements within the meaning of federal securities laws, including the “safe

harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as

“aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,”

“forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,”

“seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking

statements. All statements, other than statements of historical facts, including without limitation those regarding Alumis’ plans to submit

an NDA in the second half of 2026, the potential for envudeucitinib to transform the treatment landscape for IL-23/IL-17-driven diseases

as well as those driven by Type I interferon, the potential for envudeucitinib to meaningfully elevate care for and effectively reduce

the full burden of disease for patients with moderate-to-severe plaque psoriasis, the expected availability of one-year Phase 3 long-term

data in the second half of 2026, the development of a once-daily formulation and a pediatric development plan for envudeucitinib, the

ongoing nature of the ONWARD clinical program, the timing of Alumis’ topline readout in its LUMUS Phase 2b program and statements regarding

Alumis’ future plans and prospects, including development of its clinical pipeline; and any assumptions underlying any of the foregoing,

are forward-looking statements. Any forward-looking statements in this Report are based on Alumis’ current expectations, estimates and

projections only as of the date of this Report and are subject to a number of risks and uncertainties that could cause actual results

to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are cautioned that actual

results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially from those expressed or

implied in Alumis’ forward-looking statements due to a variety of risks and uncertainties, which include, without limitation, risks and

uncertainties related to whether regulatory authorities determine that envudeucitinib in moderate-to-severe plaque psoriasis is sufficiently

safe and efficacious and grant regulatory approval; whether regulatory authorities accept for filing Alumis’ planned NDA submission; Alumis’

ability to obtain regulatory approval of and ultimately commercialize Alumis’ clinical candidates, the timing and results of preclinical

and clinical trials, Alumis’ ability to fund development activities and achieve development goals, and Alumis’ ability to protect its

intellectual property. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that

could cause actual results to differ materially from those in the forward-looking statements are contained in Alumis’ filings and reports

with the SEC under the heading “Risk Factors” and elsewhere in such filings and reports, including any future reports Alumis

may file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to

the extent required by law.

Item 9.01 Financial Statements and Exhibits.

(d)   Exhibits.

Exhibit

No.

Description

99.1

Press Release, dated March 28, 2026.

99.2

Late-Breaker Presentation, dated March 28, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities

Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Alumis Inc.

By:

/s/ Martin Babler

Martin Babler

President & Chief Executive Officer

Dated: March 30, 2026

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: tm269978d1_ex99-1.htm · Sequence: 2

Exhibit 99.1

Alumis’ Envudeucitinib Delivers Early

and Robust Improvements in Skin Clearance, Quality of Life and Psoriasis Symptoms in Two Phase 3 Trials, Underscoring Its Potential as

a Leading Oral Therapy for Plaque Psoriasis

- Envudeucitinib achieved robust PASI responses by Week 16, with significant continued improvements by Week 24 in PASI 90 (68.0%, 62.1%) and PASI 100 (41.0%, 39.5%)

- Quality-of-life improvements and itch relief emerged ahead of PASI 90 skin clearance, and clear or almost clear scalp psoriasis emerged by Week 4, highlighting envudeucitinib’s early onset and broad clinical benefit

- Envudeucitinib demonstrated a favorable safety and tolerability profile consistent with the Phase 2 program

- Results presented as a late-breaking oral presentation at the 2026 American Academy of Dermatology (AAD) Annual Meeting

- Conference call and webcast scheduled for March 29, 2026, at 5:00 pm MDT / 7:00 pm EDT

SOUTH

SAN FRANCISCO, Calif., March 28, 2026 (GLOBE NEWSWIRE) -- Alumis Inc. (Nasdaq: ALMS), a late-stage biopharmaceutical company

developing next-generation targeted therapies for patients with immune-mediated diseases, today announced new data from its

Phase 3 ONWARD1 and ONWARD2 clinical trials evaluating

envudeucitinib, a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor for moderate-to-severe plaque psoriasis.

The data were presented in a late-breaking oral session at the 2026 AAD Annual Meeting.

Envudeucitinib

demonstrated robust skin clearance, achieving high thresholds of clinical response at Week 16 that continued to deepen through Week 24

in both trials. Psoriasis Area and Severity Index (PASI) 90 responses,

which emerged as early as Week 4, were achieved by 59.9% and 53.1% of envudeucitinib patients at Week 16

(and by 4.8% and 4.3% of placebo patients), increasing to 68.0% and 62.1% at Week 24.

PASI 100 responses followed a similar trajectory, with 29.4% and 27.7%

of envudeucitinib patients achieving complete skin clearance at Week 16

(as compared to 0.9% and 0.9% of placebo patients), rising to 41.0% and 39.5% at Week 24.

Envudeucitinib

also demonstrated improvements in scalp psoriasis, a high-impact, difficult-to-treat area marked by profound effects on quality of life.

At Week 24, approximately three out of four envudeucitinib

patients1 achieved clear or almost clear

scalp psoriasis, measured by the Scalp Specific Physician’s Global Assessment (ss-PGA 0/1),

with over 30% responding as early as Week 4.

1

Based on patients with baseline ss-PGA ≥3

Broad

and meaningful clinical benefits emerged early. Notably, quality-of-life and itch improvements appeared before PASI 90

skin clearance responses and continued to deepen through Week 24 across both trials.

· By Week 12, approximately 50% of envudeucitinib patients2

achieved Dermatology Life Quality Index (DLQI) 0/1, demonstrating

minimal to no impact of disease on quality of life.

· By

Week 16, envudeucitinib patients achieved an average improvement

of more than 4 points from baseline on the 0–10 Worst Pruritus Numeric Rating Scale (NRS), with clinically meaningful itch relief

as early as Week 2—one of the most burdensome symptoms of psoriasis.

“What

stands out with envudeucitinib in these trials is how quickly patients begin to feel relief from symptoms, and how deeply those improvements

continue to build,” said leading dermatologist and psoriasis expert Dr. Andrew Blauvelt. “For people living with the daily

burden of plaque psoriasis, this degree of skin clearance and symptom improvement from an oral investigational drug is impressive, especially

when high-impact sites are involved.”

Treatment

with envudeucitinib was generally well tolerated through Week 24

in both trials, with a safety profile consistent with the Phase 2

program, including its long-term extension study. No clinically significant laboratory abnormalities or cases of tuberculosis

reactivation were observed. Treatment-emergent adverse events were mostly mild, transient, self-limited, or responding to standard

therapy, with the most common being headache, nasopharyngitis, upper respiratory tract infection, and acne. No new safety signals

were observed.

“Envudeucitinib

delivered the level of skin clearance, symptom relief, and safety in Phase 3 that the TYK2 mechanism has long promised but that has not

been fully realized—until now—with sustained, maximal 24-hour inhibition of the IL-23 / IL-17 pathways,” said Dr. Jörn Drappa,

Chief Medical Officer of Alumis. “The depth of clinical response, together with the favorable safety profile observed, underscores

a differentiated clinical profile among marketed and investigational oral options and supports envudeucitinib’s potential to play

a leading role in the treatment of patients with moderate-to-severe plaque psoriasis.”

Alumis is continuing to evaluate the long-term efficacy and safety

of envudeucitinib in the ONWARD3 long-term extension trial and plans to submit a New Drug Application to the U.S. Food and Drug Administration

in the second half of this year.

Conference

Call, Presentation and Webcast Details

Alumis will host a webcast for the investment community to review

the Phase 3 ONWARD results presented at AAD which will begin at 5:00 pm MDT / 7:00 pm EDT on Sunday, March 29, 2026. The live

webcast can be accessed via this link or on the Events tab on the Investors section of the Company’s

website. A replay of the webcast will be made available on the Company’s website following the call. In addition, Alumis has posted

the AAD presentation under the Publications section of the Company's website.

2

Based on patients with baseline DLQI ≥2

About

the Phase 3 ONWARD Clinical Program

The Phase 3 ONWARD clinical program includes two parallel global, multicenter, randomized,

double-blind, placebo and active-comparator-controlled 24week trials—ONWARD1 (NCT06586112) and ONWARD2 (NCT06588738)—evaluating

the efficacy and safety of envudeucitinib in adults with moderate-to-severe plaque psoriasis. More than 1,700 patients were enrolled

and randomized 2:1:1 to receive envudeucitinib 40 mg twice daily, placebo, or apremilast. Co-primary endpoints at Week 16 were the proportion

of patients achieving Psoriasis Area and Severity Index (PASI) 75 and static Physician’s Global Assessment (sPGA) 0/1 compared

with placebo. Patients completing Week 24 were eligible to enter ONWARD3 (NCT06846541), an ongoing long-term extension study assessing

durability, greater maintenance of response, and long-term safety. The ONWARD clinical trials did not have a fasting requirement.

About

Envudeucitinib

Envudeucitinib is a next-generation, highly selective, oral allosteric inhibitor of tyrosine kinase 2 (TYK2)

precision-engineered for maximal 24-hour TYK2 inhibition to correct immune dysregulation across a range of diseases driven by proinflammatory

mediators, including IL-23, IL-17, and Type I interferon. It is the only TYK2 inhibitor shown to deliver maximal target inhibition over

24 hours in humans. Clinical data indicate its selective targeting delivered sustained, maximal 24-hour inhibition in patients with psoriasis

while minimizing off-target binding and effects. Alumis is currently evaluating the long-term efficacy and safety of envudeucitinib in

the Phase 3 ONWARD3 clinical program for moderate-to-severe plaque psoriasis. Envudeucitinib is also being evaluated in LUMUS, a potentially

pivotal Phase 2b clinical trial in patients with systemic lupus erythematosus, with topline data expected in the third quarter of 2026.

About

Plaque Psoriasis

Plaque psoriasis is a chronic, immune-mediated disease driven by dysregulated IL-23 and IL-17 pathways that

cause painful, itchy, scaly patches. It affects more than 8 million adults in the U.S. and often involves high-impact areas such as the

scalp, face, hands, feet, and nails, significantly disrupting daily life. According to the National Psoriasis Foundation, about one in

four patients has moderate-to-severe disease, based on quality-of-life impact and body surface area involved. Many remain inadequately

controlled on current oral and topical treatments, underscoring the need for more effective, safe, and durable oral options that address

the full burden of disease.

About

TYK2 in Immune-Mediated Disease

Tyrosine kinase 2 (TYK2) is a key immune-signaling enzyme that regulates pathways across innate

and adaptive immunity, including the IL-23/IL-17 axis and Type I interferon signaling that drive many high-burden immune-mediated diseases.

Selective TYK2 inhibition has been widely validated as an effective, safe, and well-tolerated therapeutic approach. Genomic analyses

conducted by Alumis highlight TYK2’s broad therapeutic potential, showing that it contributes to the pathogenesis of roughly 20

immune-driven conditions—including psoriasis, lupus, psoriatic arthritis, rheumatoid arthritis, Crohn’s disease, and ulcerative

colitis. Additional evidence supports a genetic rationale for TYK2 inhibition in neuroinflammatory and neurodegenerative diseases where

targeting TYK2 may offer a novel approach to treatment.

About

Alumis

Alumis is a late-stage biopharma company developing next-generation

targeted therapies with the potential to significantly improve patient health and outcomes across a range of immune-mediated diseases.

Leveraging its proprietary data analytics platform and precision approach, Alumis is developing a pipeline of oral tyrosine kinase 2

inhibitors, consisting of envudeucitinib for the treatment of systemic immune-mediated disorders, such as moderate-to-severe plaque psoriasis

and systemic lupus erythematosus, and A-005 for the treatment of neuroinflammatory and neurodegenerative diseases. In addition, the pipeline

includes lonigutamab, a subcutaneously delivered anti–insulin-like growth factor 1 receptor therapy for the treatment of thyroid

eye disease, as well as several preclinical programs identified through this precision approach. For more information, visit www.alumis.com

or follow us on LinkedIn or X.

Forward-Looking

Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including

the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified

by words such as "aims," "anticipates," "believes," "could," "estimates," "expects,"

"forecasts," "goal," "intends," "may," "plans," "possible," "potential,"

"seeks," "will" and variations of these words or similar expressions that are intended to identify forward-looking

statements. All statements, other than statements of historical facts, including without limitation those regarding Alumis’ plans

to submit an NDA in the second half of 2026, the potential for envudeucitinib to play a leading role in the treatment of patients with

moderate-to-severe plaque psoriasis, the timing of Alumis’ topline readout in its LUMUS Phase 2b program and statements regarding

Alumis’ future plans and prospects, including development of its clinical pipeline; and any assumptions underlying any of the foregoing,

are forward-looking statements. Any forward-looking statements in this press release are based on Alumis’ current expectations,

estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause

actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Readers are

cautioned that actual results, levels of activity, safety, efficacy, performance or events and circumstances could differ materially

from those expressed or implied in Alumis’ forward-looking statements due to a variety of risks and uncertainties, which include,

without limitation, risks and uncertainties related to whether regulatory authorities determine that envudeucitinib in moderate-to-severe

plaque psoriasis is sufficiently safe and efficacious and grant regulatory approval; whether regulatory authorities accept for filing

Alumis’ planned NDA submission; Alumis’ ability to obtain regulatory approval of and ultimately commercialize Alumis’

clinical candidates, the timing and results of preclinical and clinical trials, Alumis’ ability to fund development activities

and achieve development goals, and Alumis’ ability to protect its intellectual property. Additional information on

the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially

from those in the forward-looking statements are contained in Alumis’ filings and reports with the Securities and Exchange Commission

(SEC) under the heading “Risk Factors” and elsewhere in such filings and reports, including any future reports Alumis may

file with the SEC from time to time. Alumis explicitly disclaims any obligation to update any forward-looking statements except to the

extent required by law.

Alumis Contact Information

Teri Dahlman

Red House Communications

teri@redhousecomms.com

EX-99.2 — EXHIBIT 99.2

EX-99.2

Filename: tm269978d1_ex99-2.htm · Sequence: 3

1

Envudeucitinib (ESK-001) in Moderate-to-Severe Plaque

Psoriasis: 24-Week Results From the Randomized,

Double-Blind, Active Comparator- and Placebo-Controlled, Phase 3 ONWARD 1 and 2 Studies

Andrew Blauvelt1, Howard Sofen2, April Armstrong3, Benjamin Ehst4-6

,

Jennifer Soung7, Maryam Shayesteh Alam8, David Rodriguez9, Jolanta Weglowska10

,

Domenico Vitarella11, Grace Ma11, Elisa Muscianisi11

1Blauvelt Consulting, LLC, Annapolis, MD, USA; 2Department of Medicine/Dermatology, David Geffen School of Medicine at UCLA, Los

Angeles, CA, USA; 3Division of Dermatology, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA; 4Oregon Medical Research

Center, Portland, OR, USA; 5Broadway Medical Clinic, Portland OR, USA; 6Oregon Health & Science University, Portland, OR, USA;

7Southern California Dermatology Inc., Santa Ana, CA, USA; 8SimcoDerm Medical and Surgical Dermatology Centre, Barrie, ON, Canada;

9International Dermatology Research, Inc., Miami, FL, USA; 10Department of Dermatology, Research and Development Center, Regional

Specialist Hospital, Wrocław, Poland; 11Alumis Inc., South San Francisco, CA, USA.

Exhibit 99.2

2

Disclosures

〉 Presenting author: AB has served as a speaker for and received honoraria from Almirall, Eli Lilly, LEO Pharma,

Sanofi, and UCB; has served as a scientific adviser for and received honoraria from AbbVie, Almirall, Alumis Inc.,

Amgen, AnaptysBio, Apogee Therapeutics, Arcutis Biotherapeutics, Eli Lilly, Incyte, Janssen, LEO Pharma, Novartis,

Oruka Therapeutics, Pfizer, Regeneron Pharmaceuticals, Sanofi, Sun Pharma, Takeda, and UCB; and owns stock in

Lipidio Pharma and Oruka Therapeutics

〉 Coauthors (relevant to study): HS has nothing to report. AA has served as a research investigator, scientific

adviser, or speaker for Alumis Inc. BE has received fees/honoraria/royalties as an advisory board member,

contributor, and/or consultant for Alumis Inc., and received institutional funding as an investigator for Alumis Inc.

JS has served as an investigator for Alumis Inc. MSA and DR have nothing relevant to disclose. JW has served as an

investigator for Alumis Inc. DV, GM, and EM are employees and shareholders of Alumis Inc.

〉 All authors met the ICMJE authorship criteria and had full access to relevant data

〉 The ONWARD program is currently ongoing, and these studies were sponsored by Alumis Inc.

〉 Envudeucitinib is an investigational therapy not reviewed or approved by any regulatory agency

ICMJE, International Committee of Medical Journal Editors.

Envudeucitinib is an investigational therapy not reviewed or approved by any regulatory agency.

IL-12/17/23, interleukin 12/17/23; IFN-I, interferon type I; JH1/2, Janus kinase homology 1/2; TYK2, tyrosine kinase 2; TYK2i, TYK2 inhibitor.

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. 3. Papp KA, et al. J Am Acad Dermatol. 2026;94(1):187-95.

3

Envudeucitinib: A Next-Generation TYK2i for Moderate-to-Severe Psoriasis

〉 Envudeucitinib, a next-generation, oral, allosteric TYK2i, provides maximal inhibition over a

24-hour period in patients with psoriasis1,2

〉 STRIDE Phase 2 and its open-label extension results demonstrated the favorable benefit/risk profile

of envudeucitinib, with meaningful clinical efficacy throughout 52 weeks, and good tolerability2,3

Envudeucitinib

TYK2

ATP

JH2 domain

Regulatory

binding site

JH1 domain

Catalytic

active site

IL-12, IL-23, IFN-I

IL-23/IL-17,

IL-12, and IFN-I

pathways blocked

Reduced circulating

cytokines driving

psoriasis

4

ONWARD1 and ONWARD2: Study Designs and Endpoints

aReplicate design; actual enrollment is reported as ONWARD1 (NCT06586112); ONWARD2 (NCT06588738).

BID, bis in die (twice daily); BSA, body surface area; BSL, baseline; DLQI-0/1, Dermatology Life Quality Index 0 or 1; NRS, numeric rating scale; PASI, Psoriasis Area and Severity Index; PASI 75/90/100, ≥75%/≥90%/100%

improvement in PASI; PGA, Physician’s Global Assessment; sPGA, static PGA; sPGA-0/1, sPGA 0 (clear) or 1 (almost clear); ss-PGA-0/1, scalp-specific PGA 0 (clear) or 1 (almost clear); W, week.

BSL W24

(End of Treatment)

W16

(Coprimary Endpoint)

Placebo (n = 230; 211)

Envudeucitinib 40 mg BID (n = 459; 433)

2:1:1 Randomization

Apremilast 30 mg BID (n = 223; 215)

Rollover to

ONWARD3

OR

Study

Completion

(W28 Safety

Follow-up)

W16

(Transition to

Envudeucitinib)

W2 W4 W8 W12 W20

ONWARD1 and ONWARD2a

W1

Coprimary Endpoints (vs Placebo)

〉 PASI 75

〉 sPGA-0/1

Key Secondary Endpoints

(vs Placebo or Apremilast)

〉 PASI 75/90/100

〉 sPGA-0/1

〉 Change from baseline in itch (NRS)

〉 ss-PGA-0/1 (baseline ≥3)

〉 DLQI-0/1 (baseline ≥2)

Safety Endpoints

Key Inclusion Criteria

〉 Age ≥18 years; weight >40 kg

〉 Plaque psoriasis ≥6 months

〉 BSA ≥10%; PASI ≥12; sPGA ≥3

〉 Phototherapy- or systemic therapy-eligible

Key Exclusion Criteria

〉 Nonplaque psoriasis or other

inflammatory skin conditions

〉 Immune-mediated conditions

commonly associated with psoriasis

5

Baseline Demographics and Disease Characteristics Were Balanced Across

Arms and Representative of a Typical Moderate-to-Severe Population

aIncludes Black or African American, Native Hawaiian or Other Pacific Islander, American Indian or Alaska Native, and Other or not reported. bAny prior exposure to systemic therapies for psoriasis (excluded phototherapy);

all patients were required to meet protocol-defined exclusion and washout criteria prior to Study Day 1.

BID, bis in die (twice daily); BMI, body mass index; BSA, body surface area; DLQI, Dermatology Life Quality Index; NRS, numeric rating scale; PASI, Psoriasis Area and Severity Index; SD, standard deviation; sPGA, static

Physician’s Global Assessment.

ONWARD1 ONWARD2

Envudeucitinib

40 mg BID

n = 459

Placebo

n = 230

Apremilast

30 mg BID

n = 223

Envudeucitinib

40 mg BID

n = 433

Placebo

n = 211

Apremilast

30 mg BID

n = 215

Age, years, mean (SD) 49.1 (13.4) 49.2 (13.3) 47.7 (11.8) 48.3 (13.1) 49.5 (13.3) 48.0 (12.8)

Age group, ≥65 years, n (%) 61 (13.3) 27 (11.7) 15 (6.7) 51 (11.8) 28 (13.3) 20 (9.3)

Sex, male, n (%) 300 (65.4) 156 (67.8) 152 (68.2) 283 (65.4) 135 (64.0) 135 (62.8)

Race, n (%)

White 358 (78.0) 182 (79.1) 177 (79.4) 388 (89.6) 181 (85.8) 193 (89.8)

Asian 68 (14.8) 28 (12.2) 30 (13.5) 10 (2.3) 10 (4.7) 7 (3.3)

Othera 33 (7.2) 20 (8.7) 16 (7.2) 35 (8.1) 20 (9.5) 15 (7.0)

Weight, kg, mean (SD) 90.4 (24.0) 91.0 (24.3) 88.9 (21.0) 92.3 (23.8) 91.1 (23.1) 90.8 (19.9)

BMI, kg/m2, mean (SD) 30.6 (7.2) 30.6 (7.2) 29.8 (6.5) 31.2 (7.8) 31.1 (7.3) 30.9 (5.9)

Duration of disease, years, mean (SD) 19.9 (13.5) 19.5 (13.3) 17.2 (11.8) 19.0 (13.5) 20.2 (14.5) 18.7 (14.5)

PASI, mean (SD) 20.4 (8.0) 19.9 (7.5) 20.3 (6.9) 20.6 (8.3) 21.8 (9.0) 20.4 (8.4)

sPGA of 4, n (%) 129 (28.1) 57 (24.8) 61 (27.4) 131 (30.3) 70 (33.2) 53 (24.7)

BSA % affected, mean (SD) 25.8 (15.8) 26.2 (16.0) 25.2 (14.9) 25.2 (14.7) 27.3 (16.7) 25.8 (14.1)

DLQI, mean (SD) 10.6 (6.5) 10.1 (6.7) 10.8 (6.8) 10.8 (7.0) 10.8 (6.8) 9.7 (7.1)

Worst pruritus NRS, mean (SD) 6.1 (2.7) 6.0 (2.7) 6.3 (2.6) 6.4 (2.6) 6.4 (2.4) 6.0 (2.7)

Prior systemic psoriasis treatment, n (%)b 221 (48.1) 113 (49.1) 107 (48.0) 213 (49.2) 105 (49.8) 102 (47.4)

6

Robust and Statistically Significant PASI Response Rates at Week 16

Almost 30% of patients receiving envudeucitinib achieved PASI 100 at Week 16

ONWARD1 ONWARD2

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. aCoprimary endpoint: PASI 75 at Week 16 vs placebo. ***P <0.0001 vs placebo and apremilast.

BID, bis in die (twice daily); CI, confidence interval; PASI, Psoriasis Area and Severity Index; PASI 75/90/100, ≥75%/≥90%/100% improvement in PASI.

6

ONWARD2

70.4

53.1

27.7

13.7

4.3

0.9

38.6

20.9

7.9

0

20

40

60

80

100

PASI 75 PASI 90 PASI 100

Responders, % (95% CI)

Envudeucitinib 40 mg BID (n = 433) Placebo (n = 211) Apremilast 30 mg BID (n = 215)

Week 16

***

***

***

ONWARD1

Week 16

***

***

***

a a

76.5

59.9

29.4

18.7

4.8

0.9

44.4

21.5

4.0

0

20

40

60

80

100

PASI 75 PASI 90 PASI 100

Responders, % (95% CI)

Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Apremilast 30 mg BID (n = 223)

Coprimary

Endpoint

Coprimary

Endpoint

7

Approximately 65% and 40% of patients achieved PASI 90 and PASI 100

with envudeucitinib at Week 24

ONWARD2

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. aCoprimary endpoint: PASI 75 at Week 16 vs placebo. ***P <0.0001 vs placebo and apremilast.

BID, bis in die (twice daily); CI, confidence interval; PASI, Psoriasis Area and Severity Index; PASI 75/90/100, ≥75%/≥90%/100% improvement in PASI.

70.4

53.1

27.7

13.7

4.3

0.9

38.6

20.9

7.9

0

20

40

60

80

100

PASI 75 PASI 90 PASI 100

Responders, % (95% CI)

Envudeucitinib 40 mg BID (n = 433) Placebo (n = 211) Apremilast 30 mg BID (n = 215)

Week 16 Week 24

Sustained and Continued PASI Response Rates Through Week 24

***

***

***

***

***

***

ONWARD1

76.5

59.9

29.4

18.7

4.8

0.9

44.4

21.5

4.0

0

20

40

60

80

100

PASI 75 PASI 90 PASI 100

Responders, % (95% CI)

Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Apremilast 30 mg BID (n = 223)

Week 16 Week 24

***

***

***

***

***

78.6

68.0

41.0

46.2

25.6

8.5

PASI 75 PASI 90 PASI 100

75.1

62.1

39.5

43.3

25.6

13.0

PASI 75 PASI 90 PASI 100 a a

***

8

Envudeucitinib Resulted in Rapidly Increasing, Statistically Significant

PASI 90 Response Rates vs Placebo and Apremilast

Early onset of action: Separation vs placebo observed at Week 4

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.

BID, bis in die (twice daily); CI, confidence interval; PASI 90, ≥90% improvement in Psoriasis Area and Severity Index.

0.0

4.8

27.4

45.2

59.9

66.7 68.0

0.5 0.4

2.6

4.4 4.8 18.8

39.0

0.5 2.7

7.6

15.9

21.5 22.5

25.6

0

20

40

60

80

100

0 4 8 12 16 20 24

PASI 90 Responders, % (95% CI)

Week

Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Apremilast 30 mg BID (n = 223)

/Envudeucitinib 40 mg BID (n = 205)

ONWARD1 ONWARD2

***

***

0.5 4.4

24.8

44.2

53.1 56.6

62.1

0.0

0.0

0.9

2.9 4.3 18.1

39.5

0.5 1.4

10.7

16.4 20.9

25.9

25.6

0

20

40

60

80

100

0 4 8 12 16 20 24

PASI 90 Responders, % (95% CI)

Week

Envudeucitinib 40 mg BID (n = 433) Placebo (n = 211) Apremilast 30 mg BID (n = 215)

/Envudeucitinib 40 mg BID (n = 185)

***

***

9

Envudeucitinib Demonstrated Robust and Progressive Improvement in

PASI 100 Response Rates Over Time

/Envudeucitinib 40 mg BID (n = 205)

Approximately 40% complete skin clearance at Week 24 without evidence of plateau

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.

BID, bis in die (twice daily); CI, confidence interval; PASI 100, 100% improvement in Psoriasis Area and Severity Index.

***

***

0.2 0.7

9.3

21.2

27.7

34.7

39.5

0.0 0.0

0.5

1.0

0.9

6.0

18.4

0.0 0.0

2.3

5.2

7.9

11.3

13.0

0

20

40

60

80

0 4 8 12 16 20 24

PASI 100 Responders, % (95% CI)

Week

Envudeucitinib 40 mg BID (n = 433) Placebo (n = 211) Apremilast 30 mg BID (n = 215)

/Envudeucitinib 40 mg BID (n = 185)

***

***

ONWARD1 ONWARD2

0.0 0.9

8.1

20.4

29.4

36.3

41.0

0.0 0.0

0.0

0.4 0.9

5.0

13.7

0.0 0.4

2.7

3.6 4.0 5.0

8.5

0

20

40

60

80

0 4 8 12 16 20 24

PASI 100 Responders, % (95% CI)

Week

Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Apremilast 30 mg BID (n = 223)

10

Envudeucitinib Demonstrated Significant sPGA-0/1 and sPGA-0 Responses

Approximately 60% and 30% of patients receiving envudeucitinib achieved sPGA-0/1 and sPGA-0

at Week 16, and responses continued to improve through Week 24

ONWARD1 ONWARD2

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. aCoprimary endpoint: sPGA-0/1 at Week 16 vs placebo. ***P <0.0001 vs placebo and apremilast.

BID, bis in die (twice daily); CI, confidence interval; sPGA, static Physician’s Global Assessment; sPGA-0, sPGA 0 (clear); sPGA-0/1, sPGA 0 (clear) or 1 (almost clear).

61.0

69.3

10.0

46.3 26.5

27.4

0

20

40

60

80

100

0 4 8 12 16 20 24

sPGA-0/1, % (95% CI)

Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Apremilast 30 mg BID (n = 223)

1.3

30.3

41.6

4.0 14.1

9.0

0

20

40

60

80

100

0 4 8 12 16 20 24

sPGA-0, % (95% CI)

Week

***

***

***

***

57.3

63.5

5.7

44.9 27.4

32.1

0

20

40

60

80

100

0 4 8 12 16 20 24

sPGA-0/1, % (95% CI)

Envudeucitinib 40 mg BID (n = 433) Placebo (n = 211) Apremilast 30 mg BID (n = 215)

1.4

29.3 40.6

19.5

9.8

13.0

0

20

40

60

80

100

0 4 8 12 16 20 24

sPGA-0, % (95% CI)

Week

***

***

***

***

/Envudeucitinib 40 mg BID (n = 205) /Envudeucitinib 40 mg BID (n = 185)

a a

sPGA-0/1 sPGA-0/1

sPGA-0 sPGA-0

Coprimary

Endpoint

Coprimary

Endpoint

11

Patient with severe disease (PASI, 22.3; sPGA, 4) at baseline. PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment.

Week

0

Week

2

Week

8

Week

16

Visible Skin Improvement by Week 2 With Envudeucitinib

12

Patient with moderate disease (PASI, 12.4; sPGA, 3) at baseline. PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment.

Week

0

Week

2

Week

8

Week

16

Envudeucitinib Resulted in Rapid and Significant Skin Improvement

13

Patient with severe disease at baseline (PASI, 31.8; sPGA, 4) who crossed over from placebo to envudeucitinib at Week 16. PASI, Psoriasis Area and Severity Index; sPGA, static Physician’s Global Assessment.

Week 0 Week 16 Week 24

Substantial Skin Improvement Achieved After Switching to Envudeucitinib in 8 Weeks

Placebo Envudeucitinib

14

Rapid, Significant, and Sustained Scalp Psoriasis Improvement With

Envudeucitinib

Approximately 3 in 4 patients receiving envudeucitinib achieved ss-PGA-0/1a at Week 24,

with over 30% response as early as Week 4

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.

BID, bis in die (twice daily); CI, confidence interval; ss-PGA-0/1, scalp-specific Physician’s Global Assessment 0 (clear) or 1 (almost clear).

14.3

35.1

60.9

69.1

74.5 78.7 77.4

6.2

14.2 17.0

24.6 25.2

55.4 65.6

5.5

18.7 34.7

45.9 48.0

47.0 48.7

0

20

40

60

80

100

0 4 8 12 16 20 24

ss-PGA-0/1 Responders, % (95% CI)

Week

Envudeucitinib 40 mg BID (n = 274) Placebo (n = 135) Apremilast 30 mg BID (n = 150)

/Envudeucitinib 40 mg BID (n = 122)

14.2

32.2

54.6

67.5 70.9

76.0 74.7

3.6

10.7

13.6

18.4

20.7

54.4 65.6

9.1

19.4

40.3

40.9 38.8

48.5

41.8

0

20

40

60

80

100

0 4 8 12 16 20 24

ss-PGA-0/1 Responders, % (95% CI)

Week

Envudeucitinib 40 mg BID (n = 285) Placebo (n = 140) Apremilast 30 mg BID (n = 134)

ONWARD1 ONWARD2

/Envudeucitinib 40 mg BID (n = 125)

*** ***

***

***

15

Envudeucitinib Rapidly Reduced Itch With Deepening Response Over Time

-2.0

-2.7

-3.5 -3.8

-4.1 -4.2 -4.3

-0.8 -0.6 -0.8 -1.0 -0.9

-3.0 -3.8

-1.3

-2.1

-2.5 -2.9 -2.7

-2.8 -2.7

-6

-5

-4

-3

-2

-1

0

0 4 8 12 16 20 24

Worst Pruritus NRS,

Δ Baseline, LSM (95% CI)

Week

Envudeucitinib 40 mg BID (n = 459) Placebo (n = 230) Apremilast 30 mg BID (n = 223)

/Envudeucitinib 40 mg BID (n = 205)

On average ˃4-point mean decrease from baseline in worst pruritus NRS by Week 12,

with continued symptom improvement over time

ONWARD1 ONWARD2

Intention-to-treat population. LSMs, CIs, and P-values are based on MMRM. ***P <0.0001 vs placebo and apremilast at Week 16. ††† P <0.0001 vs apremilast at Week 24 (nominal).

BID, bis in die (twice daily); CI, confidence interval; LSM, least squares mean; MMRM, mixed model for repeated measures; NRS, numeric rating scale.

-2.3

-3.2

-4.0

-4.5

-4.8 -4.9 -5.0

-0.8

-1.2 -1.4 -1.5 -1.6

-3.6 -4.3

-2.1 -2.8

-3.1

-3.3 -3.4

-3.6 -3.3

-6

-5

-4

-3

-2

-1

0

0 4 8 12 16 20 24

Worst Pruritus NRS,

Δ Baseline, LSM (95% CI)

Week

Envudeucitinib 40 mg BID (n = 433) Placebo (n = 211) Apremilast 30 mg BID (n = 215)

/Envudeucitinib 40 mg BID (n = 185)

***

***

†††

†††

16

Approximately 50% of patients receiving envudeucitinib reported DLQI-0/1a by Week 12,

with continued improvement through Week 24

ONWARD1 ONWARD2

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 DLQI ≥2. ***P <0.0001 vs placebo. ††† P <0.0001 vs apremilast (nominal).

BID, bis in die (twice daily); CI, confidence interval; DLQI-0/1, Dermatology Life Quality Index 0 (no impact) or 1 (minimal impact).

Envudeucitinib Treatment Significantly Improved Patient Quality of Life

11.4

27.1

39.6

51.7

57.5

63.4 63.7

11.3

15.6

13.3

15.2 12.3 30.8

48.9

11.4

17.9

23.2

32.2

36.2 32.5

31.9

0

20

40

60

80

100

0 4 8 12 16 20 24

DLQI-0/1 Responders, % (95% CI)

Week

Envudeucitinib 40 mg BID (n = 424) Placebo (n = 211) Apremilast 30 mg BID (n = 207)

/Envudeucitinib 40 mg BID (n = 188)

11.1

22.9

41.2

49.9

56.0 58.7 60.1

5.3

11.2

7.7

11.6 10.7

35.7

47.7

16.1

20.5

32.5

34.2

35.9

40.1

40.0

0

20

40

60

80

100

0 4 8 12 16 20 24

DLQI-0/1 Responders, % (95% CI)

Week

Envudeucitinib 40 mg BID (n = 393) Placebo (n = 196) Apremilast 30 mg BID (n = 195)

/Envudeucitinib 40 mg BID (n = 174)

***

†††

***

†††

17

Benefits in Itch Reduction and Quality of Life Visible Before Skin Clearance

Patients receiving envudeucitinib showed robust, early improvements in

DLQI and itch that preceded PASI 90 responses

ONWARD1 ONWARD2

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.

BID, bis in die (twice daily); CI, confidence interval; DLQI, Dermatology Life Quality Index; DLQI-0/1, DLQI 0 or 1; LSM, least-squares mean; MMRM, mixed model for repeated measures; NRS, numeric rating scale;

PASI 90, ≥90% improvement in Psoriasis Area and Severity Index.

Week

0

20

40

60

80

0 4 8 12 16 20 24

Responders, % (95% CI)

Envudeucitinib 40 mg BID

-8

-6

-4

-2

0

Itch Δ Baselinea (95% CI)

DLQI-0/1

PASI 90

ITCH

Week

0

20

40

60

80

0 4 8 12 16 20 24

Responders, % (95% CI)

Envudeucitinib 40 mg BID

-8

-6

-4

-2

0

Itch Δ Baselinea (95% CI)

DLQI-0/1

PASI 90

ITCH

18

ONWARD1 and ONWARD2 Pooled Safety Through Week 16

〉 Envudeucitinib showed low rates of SAEs and AEs leading to discontinuation, with no clusters of events

– No deaths; no MACE or cytopenia signals; no TB reactivationb

〉 No clinically significant laboratory abnormalities were observed across lipid, hematologic, or chemistry panels, with comparable

variability across treatment arms up to Week 16

Safety analysis population; pooled ONWARD1 and ONWARD2 data. aTEAEs occurring in ≥5% of patients in any treatment arm through either Week 16 or Week 24. bThirty-nine patients with latent or treated TB were

enrolled.

AE, adverse event; BID, bis in die (twice daily); MACE, major adverse cardiovascular event; SAE, serious AE; TB, tuberculosis; TEAE, treatment-emergent AE.

Through Week 16

n (%)

Envudeucitinib

40 mg BID

n = 890

Placebo

n = 441

Apremilast

30 mg BID

n = 438

≥1 TEAE 524 (58.9) 166 (37.6) 223 (50.9)

≥1 SAE 19 (2.1) 5 (1.1) 5 (1.1)

TEAE leading to treatment

discontinuation 30 (3.4) 7 (1.6) 9 (2.1)

TEAE grade ≥3 42 (4.7) 14 (3.2) 18 (4.1)

Most-frequent TEAEs (≥5%)a

Nasopharyngitis 64 (7.2) 21 (4.8) 16 (3.7)

Headache 92 (10.3) 11 (2.5) 40 (9.1)

Upper respiratory tract infection 43 (4.8) 7 (1.6) 16 (3.7)

Acne 53 (6.0) 3 (0.7) 3 (0.7)

Nausea 20 (2.2) 4 (0.9) 23 (5.3)

Diarrhea 14 (1.6) 11 (2.5) 36 (8.2)

19

ONWARD1 and ONWARD2 Pooled Safety Through Weeks 16 and 24

Through Week 16 Through Week 24

n (%)

Envudeucitinib

40 mg BID

n = 890

Placebo

n = 441

Apremilast

30 mg BID

n = 438

Envudeucitinib

40 mg BID

only

n = 890

Placebo to

Envudeucitinib

40 mg BID

n = 390

Overall

Envudeucitinib

40 mg BID

n = 1280

Apremilast

30 mg BID

n = 438

≥1 TEAE 524 (58.9) 166 (37.6) 223 (50.9) 563 (63.3) 130 (33.3) 693 (54.1) 248 (56.6)

≥1 SAE 19 (2.1) 5 (1.1) 5 (1.1) 24 (2.7) 1 (0.3) 25 (2.0) 6 (1.4)

TEAE leading to treatment

discontinuation 30 (3.4) 7 (1.6) 9 (2.1) 31 (3.5) 4 (1.0) 35 (2.7) 12 (2.7)

TEAE grade ≥3 42 (4.7) 14 (3.2) 18 (4.1) 48 (5.4) 7 (1.8) 55 (4.3) 23 (5.3)

Most-frequent TEAEs (≥5%)a

Nasopharyngitis 64 (7.2) 21 (4.8) 16 (3.7) 92 (10.3) 18 (4.6) 110 (8.6) 26 (5.9)

Headache 92 (10.3) 11 (2.5) 40 (9.1) 97 (10.9) 11 (2.8) 108 (8.4) 42 (9.6)

Upper respiratory tract infection 43 (4.8) 7 (1.6) 16 (3.7) 57 (6.4) 2 (0.5) 59 (4.6) 21 (4.8)

Acne 53 (6.0) 3 (0.7) 3 (0.7) 60 (6.7) 17 (4.4) 77 (6.0) 3 (0.7)

Nausea 20 (2.2) 4 (0.9) 23 (5.3) 20 (2.2) 0 20 (1.6) 23 (5.3)

Diarrhea 14 (1.6) 11 (2.5) 36 (8.2) 16 (1.8) 1 (0.3) 17 (1.3) 36 (8.2)

Safety analysis population; pooled ONWARD1 and ONWARD2 data. aTEAEs occurring in ≥5% of patients in any treatment arm through either Week 16 or Week 24. bThirty-nine patients with latent or treated TB were

enrolled.

AE, adverse event; BID, bis in die (twice daily); MACE, major adverse cardiovascular event; SAE, serious AE; TB, tuberculosis; TEAE, treatment-emergent AE.

〉 Envudeucitinib showed low rates of SAEs and AEs leading to discontinuation, with no clusters of events

– No deaths; no MACE or cytopenia signals; no TB reactivationb

〉 No clinically significant laboratory abnormalities were observed across lipid, hematologic and chemistry panels, with comparable

variability across treatment arms throughout the study

〉 At Week 24, low incidence of serious infections (0.7%) and malignancies (0.2%) observed in patients treated with envudeucitinib

20

Envudeucitinib, a next-generation TYK2i, delivered early and progressively deepening skin

clearance, with meaningful improvements in patient-reported outcomes in ONWARD1 and 2

〉All primary and secondary efficacy endpoints met, with approximately 65% and 40% of

patients receiving envudeucitinib achieving PASI 90 and PASI 100 at Week 24

〉Rapid and significant improvement in moderate-to-severe scalp psoriasis, itch, and

quality of life

〉Envudeucitinib treatment was generally well tolerated, with no new signals and a safety

profile consistent with the previous long-term Phase 2 studies

〉One year, Phase 3 long-term data will be available in the second half of 2026

〉Once-daily formulation and pediatric plan under development

Envudeucitinib is an investigational therapy not reviewed or approved by any regulatory agency.

PASI 90/100, ≥90%/100% improvement in Psoriasis Area and Severity Index; TYK2i, tyrosine kinase 2 inhibitor.

21

Acknowledgments

〉 The Authors thank the patients and their families for their participation and the study sites and teams for their

facilitation of the ONWARD clinical studies

〉 The Authors thank Komal Bawa, PharmD, of Alumis Inc., for assistance with data publication and editorial review.

Writing and editorial support were provided by Sylvia Stankov, PhD, of Red Nucleus, and were funded by Alumis Inc.

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-1img01.jpg · Sequence: 7

Binary file (3265 bytes)

Download tm269978d1_ex99-1img01.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img001.jpg · Sequence: 8

Binary file (223638 bytes)

Download tm269978d1_ex99-2img001.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img002.jpg · Sequence: 9

Binary file (187124 bytes)

Download tm269978d1_ex99-2img002.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img003.jpg · Sequence: 10

Binary file (176032 bytes)

Download tm269978d1_ex99-2img003.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img004.jpg · Sequence: 11

Binary file (176123 bytes)

Download tm269978d1_ex99-2img004.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img005.jpg · Sequence: 12

Binary file (256597 bytes)

Download tm269978d1_ex99-2img005.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img006.jpg · Sequence: 13

Binary file (146488 bytes)

Download tm269978d1_ex99-2img006.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img007.jpg · Sequence: 14

Binary file (174734 bytes)

Download tm269978d1_ex99-2img007.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img008.jpg · Sequence: 15

Binary file (176631 bytes)

Download tm269978d1_ex99-2img008.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img009.jpg · Sequence: 16

Binary file (173180 bytes)

Download tm269978d1_ex99-2img009.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img010.jpg · Sequence: 17

Binary file (211880 bytes)

Download tm269978d1_ex99-2img010.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img011.jpg · Sequence: 18

Binary file (216527 bytes)

Download tm269978d1_ex99-2img011.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img012.jpg · Sequence: 19

Binary file (196880 bytes)

Download tm269978d1_ex99-2img012.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img013.jpg · Sequence: 20

Binary file (290322 bytes)

Download tm269978d1_ex99-2img013.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img014.jpg · Sequence: 21

Binary file (190105 bytes)

Download tm269978d1_ex99-2img014.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img015.jpg · Sequence: 22

Binary file (179256 bytes)

Download tm269978d1_ex99-2img015.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img016.jpg · Sequence: 23

Binary file (185054 bytes)

Download tm269978d1_ex99-2img016.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img017.jpg · Sequence: 24

Binary file (177338 bytes)

Download tm269978d1_ex99-2img017.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img018.jpg · Sequence: 25

Binary file (145894 bytes)

Download tm269978d1_ex99-2img018.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img019.jpg · Sequence: 26

Binary file (218180 bytes)

Download tm269978d1_ex99-2img019.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img020.jpg · Sequence: 27

Binary file (171822 bytes)

Download tm269978d1_ex99-2img020.jpg

GRAPHIC

GRAPHIC

Filename: tm269978d1_ex99-2img021.jpg · Sequence: 28

Binary file (68077 bytes)

Download tm269978d1_ex99-2img021.jpg

XML — IDEA: XBRL DOCUMENT

XML

Filename: R1.htm · Sequence: 30

v3.26.1

Cover

Mar. 28, 2026

Cover [Abstract]

Document Type

8-K

Amendment Flag

false

Document Period End Date

Mar. 28, 2026

Entity File Number

001-42143

Entity Registrant Name

Alumis Inc.

Entity Central Index Key

0001847367

Entity Tax Identification Number

86-1771129

Entity Incorporation, State or Country Code

DE

Entity Address, Address Line One

280 East Grand Avenue

Entity Address, City or Town

South San Francisco

Entity Address, State or Province

CA

Entity Address, Postal Zip Code

94080

City Area Code

650

Local Phone Number

231-6625

Written Communications

false

Soliciting Material

false

Pre-commencement Tender Offer

false

Pre-commencement Issuer Tender Offer

false

Title of 12(b) Security

Common Stock, $0.0001 par value per share

Trading Symbol

ALMS

Security Exchange Name

NASDAQ

Entity Emerging Growth Company

true

Elected Not To Use the Extended Transition Period

false

X

- Definition

Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.

+ References

No definition available.

+ Details

Name:

dei_AmendmentFlag

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Area code of city

+ References

No definition available.

+ Details

Name:

dei_CityAreaCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Cover page.

+ References

No definition available.

+ Details

Name:

dei_CoverAbstract

Namespace Prefix:

dei_

Data Type:

xbrli:stringItemType

Balance Type:

na

Period Type:

duration

X

- Definition

For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

+ References

No definition available.

+ Details

Name:

dei_DocumentPeriodEndDate

Namespace Prefix:

dei_

Data Type:

xbrli:dateItemType

Balance Type:

na

Period Type:

duration

X

- Definition

The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

+ References

No definition available.

+ Details

Name:

dei_DocumentType

Namespace Prefix:

dei_

Data Type:

dei:submissionTypeItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Address Line 1 such as Attn, Building Name, Street Name

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine1

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Name of the City or Town

+ References

No definition available.

+ Details

Name:

dei_EntityAddressCityOrTown

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Code for the postal or zip code

+ References

No definition available.

+ Details

Name:

dei_EntityAddressPostalZipCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Name of the state or province.

+ References

No definition available.

+ Details

Name:

dei_EntityAddressStateOrProvince

Namespace Prefix:

dei_

Data Type:

dei:stateOrProvinceItemType

Balance Type:

na

Period Type:

duration

X

- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityCentralIndexKey

Namespace Prefix:

dei_

Data Type:

dei:centralIndexKeyItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Indicate if registrant meets the emerging growth company criteria.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityEmergingGrowthCompany

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Indicate if an emerging growth company has elected not to use the extended transition period for complying with any new or revised financial accounting standards.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 7A

-Section B

-Subsection 2

+ Details

Name:

dei_EntityExTransitionPeriod

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

Name:

dei_EntityFileNumber

Namespace Prefix:

dei_

Data Type:

dei:fileNumberItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

Namespace Prefix:

dei_

Data Type:

dei:edgarStateCountryItemType

Balance Type:

na

Period Type:

duration

X

- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityRegistrantName

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

na

Period Type:

duration

X

- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

dei_

Data Type:

dei:employerIdItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

dei_PreCommencementIssuerTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

na

Period Type:

duration

X

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

na

Period Type:

duration