Cogent Biosciences : Jefferies 2025 Cogent final

Published: 2025-06-05 08:24:06 ET COGT

Published on 06/05/2025 at 08:24

June 5, 2025

EARLY-STAGE

DEVELOPMENT

LATE-STAGE

DEVELOPMENT

REGULATORY

SUBMISSION

APPROVAL

CLINICAL

Bezuclastinib

CGT4859 (FGFR2/3)

Nonadvanced Systemic Mastocytosis (NonAdvSM) Gastrointestinal Stromal Tumors (GIST)

Advanced Systemic Mastocytosis (AdvSM)

FGFR2/3 inhibitor

SUMMIT Part 2 (Registration-Directed)

Top-line results expected July 2025

PEAK Part 2 (Global Phase 3 trial)

Top-line results expected by EOY 2025

APEX Part 2 (Registration-Directed)

Top-line results expected 2H 2025

Phase 1 trial initiated, actively enrolling FGFR 2/3 alteration patients

RESEARCH

ErbB2 Pl3Kα KRAS

Undisclosed Targets

HIT ID LEAD GENERATION LEAD OPTIMIZATION CANDIDATE SELECTED IND SUBMISSION

CGT4255 is a potent, selective, CNS-penetrant ErbB2 inhibitor CGT6297 is a novel mutant-selective PI3Kα inhibitor

CGT9109 is a novel pan KRAS(ON) inhibitor

$245.7M as of Q1 25; expected to fund operations into late 2026

3

2024

2025

Enrolled ~6 months early

LPFV

TLR

July

Enrolled ~6 months early

LPFV

TLR

By EOY

Patient screening complete

LPFV

TLR

2H

Registration-directed study in NonAdvSM bezuclastinib vs. placebo

n=179, 24-week MS2D2 primary endpoint

$2 billion US annual market opportunity; differentiated symptom improvement would provide path to market leadership

Phase 3 study in 2nd-line GIST bezuclastinib +/- sunitinib

n=413, PFS primary endpoint

$1 billion+ US annual market opportunity, limited competition for 2nd-line GIST

Registration-directed study in AdvSM bezuclastinib monotherapy

n=58, ORR primary endpoint

LPFV: Last patient, first visit

TLR: Top-line results including primary endpoint

4

Aggregate US annual sales opportunity >$3 billion with limited competition

Gastrointestinal Stromal Tumors (GIST)

Systemic Mastocytosis

sunitinib

Approved

Exon 17/18 potent:

Exon 13/14 potent:

2nd-line status:

ripretinib

Failed

bezuclastinib

+ sunitinib

Phase 3 TLR

by EOY

D816V potent: CNS selective: PDGFR sparing:

avapritinib elenestinib

bezuclastinib

Approved n/a

TLR 2H '25

Approved Phase 2

initiated

TLR July

FLT3/CSF1R sparing:

Late-stage: None

Early-stage: IDRX-42

Other competitors

Current Stage

ASM:

NonAdvSM:

Other competitors:

None

5

Disclaimer

Cogent Biosciences Inc. published this content on June 05, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on June 05, 2025 at 12:23 UTC.