Syndax Pharmaceuticals : SNDX 1Q26 Earnings Deck FINAL

Published: 2026-04-30 20:08:52 ET SNDX

Published on 04/30/2026 at 08:08 pm EDT

April 30, 2026

$49M Revuforj net revenue in 1Q26, highlighting leadership in menin inhibition

$55M Niktimvo net revenue in 1Q26, resulting in $16M in collaboration revenue

$65M in total revenue to Syndax in 1Q26, up 224% vs. 1Q25

ROBUST COMMERCIAL DEMAND

EXCELLENT PIPELINE PROGRESS

Positioned to be 1st to frontline (1L) AML with a menin inhibitor

Major presence planned at upcoming medical meetings with new real-world, 1L, R/R, and post-HSCT data expected in 2Q26 and 2H26

Topline data from Phase 2 trials of axatilimab in IPF and newly diagnosed cGVHD anticipated in 4Q26

STRONG FINANCIAL POSITION

Growing product revenues from two first- and best-in-class medicines

Robust balance sheet and stable expense outlook

On the road to profitability

1Q26 Revuforj results highlight leadership in menin inhibition and growing use in R/R NPM1m AML

1Q26 Revuforj results

$48.9M

net revenue

11% growth vs. 4Q25

≥30%

of net revenue

from NPM1 business

>1,300 TRx

~13% growth vs. 4Q25, even with nearly 50% of KMT2A pts pausing Tx to proceed to HSCT

EXCEPTIONAL

LAUNCH

Cumulative since

launch in Nov '24:

>$180M

net revenue

~1,380

patients treated

≥40% of 1Q26 new patients were NPM1m

TRx, total prescriptions; HSCT, hematopoietic stem cell transplant; Tx, treatment

1Q26

4Q25

3Q25

2Q25

1Q25

100

~200

200

~250

~300

300

Growth in new patient starts driven by

expanding uptake in R/R NPM1m AML

New patients per quarter

NPM1m KMT2Ar

~330

Revuforj is positioned for success with an outstanding commercial foundation

Excellent payer coverage with no meaningful barriers to access

of all covered lives with formulary coverage for both Revuforj indications

Robust and growing prescriber base with

>85% of Tier 1+2 accounts activated

Tier 1+2 account activation

100%

>85%

80%

65%

70%

>80%

60%

40%

20%

44%

1Q25

2Q25

3Q25

4Q25

1Q26

All covered lives includes all commercially covered lives plus Medicare and Medicaid lives.

Evolving clinical practice will drive continued Revuforj growth in 2026

Growing adoption in

R/R NPM1m AML

Robust transplant rate in KMT2Ar and usage post-transplant

Use in early lines of R/R treatment and in combinations

Significant room for further growth within a ~4,500 annual incident patient population

patient population

Nearly 50% of KMT2A patients proceed to HSCT and ~45% have resumed Tx thus far

Tx durations

~70% of use in 2L/3L

~40% of use in combination

Tx durations

Average duration of therapy expected to extend as treatment patterns mature and an increasing number of patients return to therapy post-HSCT

R/R, relapsed/refractory; 2L, second line; 3L, third line; HSCT, hematopoietic stem cell transplantation; Tx, treatment

40-45%

25-30%

20-25%

Current Revuforj indications unlock $2B+ TAM in R/R acute leukemia

$5B+ TAM across R/R and 1L

$2B+ TAM in R/R

U.S. Market Opportunity ($ B)

R/R acute leukemia with KMT2A translocation

R/R AML

with NPM1m

1L "Unfit" AML with KMT2Ar or NPM1m

1L "Fit" AML with KMT2Ar or NPM1m

Est. annual incidence

~2,000 ~4,500 ~3,500 ~5,500

Comprehensive clinical development program underway to unlock

$5B+ TAM across acute leukemia Tx continuum

With the largest addressable population and anticipated duration of therapy, Revuforj is poised to become the largest targeted AML therapy

Addressable AML population

Revuforj

FLT3

inhibitors

IDH

inhibitors

Building off an excellent first year, Niktimvo delivered strong 1Q26 results driven by robust demand

$15.9M

1Q26 collaboration revenue to SNDX

Compared to -$0.2M in 1Q25, the first partial quarter of launch

~300

1Q26 new patient starts

~5,000

1Q26 infusions administered

$55.1M

1Q26 net revenue to INCY

Compared to $13.6M in 1Q25, the first partial quarter of launch

REMARKABLE

LAUNCH

Performance reflects strong, consistent new patient starts and solid persistency, offset by natural attrition among the large cohort of predominantly later-line patients who started in the first quarter of launch last year

Cumulative since

launch in late Jan '25:

$207M

net revenue

>1,700

patients treated

Syndax records 50% of the Niktimvo net commercial profit, defined as net revenue (recorded by Incyte) minus the cost of sales and commercial expenses. 8

Multiple drivers support continued Niktimvo growth in 2026

Continued adoption in 4L and growing usage in 3L cGVHD

Potential for extended treatment durations to address chronic disease

Broad and growing prescriber base & strong commercial synergies

~32% share of 3L+ cGVHD

market within 1 year of launch

population and Tx durations

~60-70% of pts who started in

1Q25 remained on Tx in 1Q26

Tx durations

Nearly every U.S. BMT center has ordered and become a repeat customer

utilization

Initial Niktimvo indication represents a $2B U.S. market opportunity, with substantial opportunities for label and geographic expansion

~17,000 U.S. cGVHD patients1

$5B+ TAM

~6,500

currently treated 3L+ U.S. cGVHD

patients

~35,000 cGVHD patients W.W.2

~150,000 U.S. | ~280,000 W.W.

Idiopathic pulmonary fibrosis (IPF) patients3

Ph 2 IPF trial underway, the first of several potential areas for further

pipeline expansion

Ph 3 cGVHD trial underway outside the U.S.

Ongoing combo trials could support future expansion into 1L cGVHD

$2B TAM

with initial Niktimvo indication

cGVHD, chronic graft-versus-host disease; 1. Internal data on file; 2. SmartImmunology Insights cGVHD report March 2020; 3. SmartImmunology Insights IPF report March 2020. * IPF trial will be conducted

and funded by Syndax.

Focused on unlocking revumenib's full potential

Revumenib (select trials)

Ph 1

Ph 2

Ph 3

FDA

Approved

Setting

Study Name

Regimen

NPM1m

KMT2Ar

NUP98r

R/R

AUGMENT-101

Rev mono

●

AUGMENT-102

Rev + IC

●

SAVE

Rev + ven/oral HMA

●

Borate study

Rev + gilt in FLT3

co-mutated

●

Post-HSCT Maintenance

Ball study

Rev mono

●

Unfit for IC

BEAT AML

Rev + ven/aza

●

SAVE

Rev + ven/oral HMA

●

EVOLVE-2

Rev + ven/aza

●

Fit for IC

708 and NCI

Rev + IC

●

REVEAL-ND

Rev + IC

●

RAVEN

Rev + ven/aza

●

ANTICIPATED UPCOMING DATA

Additional real-world evidence in 2Q26

New post-HSCT maintenance data in 2Q26

Updated Ph 1 frontline rev + IC data in 2Q26

Updated SAVE R/R and

NUP98r R/R data in 2Q26

Updated BEAT AML

frontline data in 2H26

Updated Ph 1 R/R

rev + gilt data in 2H26

Rev, revumenib; IC, intensive chemotherapy; 1L, frontline; R/R, relapsed or refractory; ven/aza, venetoclax and azacitidine; HMA, hypomethylating agent; HSCT, hematopoietic stem cell transplantation; RWE, real-world evidence; gilt, gilteritinib

Global enrollment

underway in pivotal 1L trials

Positioned to be

1st to the 1L with a menin inhibitor

Strong presence

planned at ASCO, EHA, and ASH and other key meetings

Robust clinical development plan underway to unlock the potential for axatilimab in 1L cGVHD, IPF, and beyond

Axatilimab (select trials)

Ph 1

Ph 2

Ph 3

FDA

Approved

Setting

Study Name

Regimen

R/R cGVHD

AGAVE-201

Axatilimab (axa) monotherapy

1L cGVHD

AXemplify-357*

Axatilimab + corticosteroids

NCT06388564*

Axatilimab + ruxolitinib

IPF

MAXPIRe

Axatilimab on top of SOC

ANTICIPATED UPCOMING DATA

Topline Ph 2 MAXPIRe

IPF data in 4Q26

Topline Ph 2 axa + rux

data now in 4Q26

Topline Ph 3 axa + steroids

data in early 2028

*Trials led by Incyte. List is not inclusive of ongoing ex-U.S. trials.

Near-term Phase 2

data readouts in IPF and newly diagnosed cGVHD could open transformative opportunities

A growing body of evidence points to CSF1-dependent monocyte-derived alveolar macrophages as a promising new target in IPF

Key discoveries:

Monocyte-derived alveolar macrophages drive lung fibrosis

Colony stimulating factor-1 receptor (CSF1R) signaling is a key regulator of monocytes and macrophages

Multiple studies implicate the CSF1R pathway in IPF:

Higher CSF1R levels observed in IPF

patients vs. healthy controls

Higher CSF1R levels predict shorter survival in IPF patients

Higher monocyte levels predict shorter survival in IPF patients

Misharin J Exp Med 2017; Byrne Trends Mol Med 2016; Joshi Eur Respir J 2020; Scott Respir Med 2019; Oldham ERJ Open Res 2023; Michalaki ERS 2024.

Axatilimab is a CSF1R-blocking antibody targeting monocyte-derived alveolar macrophages in IPF

Development in IPF supported by lung responses observed in cGVHD

Blocking CSF-1R with axatilimab:

Reduces levels of circulating profibrotic and proinflammatory monocytes and monocyte-derived macrophages

Inhibits the activity of pathogenic macrophages in tissues

Among cGVHD pts with lung involvement who received axa

0.3 mg/kg Q2W, nearly 50% achieved a lung response and

>90% reported improvements in shortness of breath at rest

Lung responses were observed across all subgroups, including patients with difficult-to-treat, severe disease

Salhotra et al., oral Presentation at ATS 2025; Salhotra et al., poster presentation at ERS 2024.

Topline data from MAXPIRe Phase 2 trial of axatilimab in IPF anticipated in 4Q26

A randomized, double-blind, placebo-controlled, multi-center international trial

Axatilimab 0.3 mg/kg Q2W

(n≈90)

Key eligibility criteria:

≥40 yrs of age

HRCT confirming IPF diagnosis

FVC ≥45% of predicted normal (PN)

FEV1/FVC ≥0.7

DLCO ≥30% and ≤90% PN

Stable background use of pirfenidone or nintedanib allowed

(N≈135)

26-week treatment

Placebo Q2W

(n≈45)

Randomized 2:1 to axatilimab or placebo; stratified by background

antifibrotic therapy (pirfenidone, nintedanib, or none)

SECONDARY ENDPOINTS:

Disease progression, SGRQ (quality of life measures), change in FVC % predicted, DLCO

PRIMARY ENDPOINT:

Annualized rate of decline in FVC over 26 weeks (ml)

ClinicalTrials.gov ID: NCT06132256; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; SGRQ, St. George's Respiratory Questionnaire; DLCO, diffusion capacity for carbon monoxide; HRCT, high-resolution computed 15

tomography

Strong financial position driven by growing revenue and stable expense outlook

Financial Summary

($ in millions)

Three Months Ended March 31

2026

2025

Product revenue, net

48.9

20.0

Collaboration revenue, net

15.9 -

Total revenues

64.9

20.0

Cost of product sales

(2.6)

(0.9)

Research & development (R&D)

(58.8)

(61.6)

Selling, general and administrative (SG&A)

(37.6)

(41.0)

Total operating expenses

(99.1)

(103.8)*

Other (expense) income, net

(8.5)

(1.1)

Net loss

(42.7)

(84.8)

On the road to

profitability

AS OF 31 MAR 2026:

$352.1M

in cash and equivalents1

88.8M

shares outstanding2

2026 R&D + SG&A

EXPENSE GUIDANCE:

$400M, excluding $50M

in expected stock option expense

Continued focus on driving revenue growth and pipeline progress, with another data-rich year ahead

2026 Anticipated Milestones

2025 Key Accomplishments Advance global enrollment in pivotal 1L trials of revumenib

Executed two strong product launches

Expanded Revuforj into 2nd indication

Initiated 1st pivotal 1L trial of a menin inhibitor

Presented first RWE for a menin inhibitor

✓

Initiated managed access program, expanding access to Revuforj in certain OUS regions

Advance leadership in menin inhibition with new 1L, maintenance, R/R, and real-world evidence for revumenib

Report topline Ph 2 axatilimab data in IPF and newly diagnosed cGVHD in 4Q26

Initiate RAVEN 1L trial of revumenib in fit KMT2Ar in 2H26

Initiate a program to generate proof-of-principle clinical data with revumenib in myelofibrosis

1L, frontline; RWE, real-world evidence; OUS, outside the United States

Disclaimer

Syndax Pharmaceuticals Inc. published this content on April 30, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on April 30, 2026 at 23:49 UTC.