08/30/2024

5 Smid-Cap biotech stocks with Big Phase2/3 readouts in September 2024

by Charle

$SMMT Ivonescimab / NSCLC / Phase 3

Bispecific antibody that binds PD-1 & VEGF and has the potential to drive synergistic anti-tumor activity

First Drug to Achieve Clinically Meaningful Benefit over Pembrolizumab

HARMONi-2, Featuring lvonescimab Monotherapy vs. Pembrolizumab Monotherapy,to be Showcased in Presidential Symposium at WCLC 2024

Ivonescimab Monotherapy Decisively Beats Pembrolizumab Monotherapy Head-to-Head, Achieves statistically significant Superiority in PFs in First-Line Treatment ofPatients with PD-L1 Positive NsCLc in china

$BCYC BT8009 (zelenectide pevedotin) / Metastatic bladder cancer / Phase 2/3

First-in-class BTC® molecule, potential to treat Nectin-4 expressing tumors.

zelenectide pevedotin treatment-related adverse events inmUC patients were low, including those ofinterest seen withother Nectin-4 targeted therapies

support long duration of response zelenectide pevedotin shows an emerging profile that may

zelenectide pevedotin response data in EV-naive mUC

$VRDN VRDN-001/ Active TED / Phase 3

Monoclonal antibody that binds & blocks the IGF-1R signaling pathway with sub-nanomolar affinity & is clinically validated for the treatment of TED.

TED is an autoimmune condition characterized by inflammation.growth, and damage to tissues around and behind the eyes

Phase 2: VRDN-001 in active TED showed robust clinical activityafter two infusions in all dose cohorts

Phase 2:VRDN-001 IV was well tolerated in active TED

$ATHA Fosgonimeton (ATH-1017) /Alzheimer's / Phase 2/3

Small molecule specifically designed to enhance the activity of neurotrophic HGF system and its receptor, MET. Presentation at the 17th CTAD on 10/29-11/1, 2024.

Neurotrophic factors, including HGF, are a less appreciated approach toaddressing neurodegenerative disease

Fosgonimeton phase 2/3 LIFT-AD trial after amendments

Independent unblinded analysis by DMC supports thepotential clinically meaningful activity of fosgonimeton

$GRTS GRANITE /MSS-CRC / Ph2/3

Personalized cancer vaccine that generates Neoantigen-Specific T Cells, kills tumor cells, and appeared to prolong OS.

OVERVlEW: Phase 2 Preliminary Results Multiple positive signals support driving GRANITE forward toward Phase 3; PFS is viable primary endpoint

GRANITE Extends PFS in High-Risk Group* With Median PFS 12 vs 7moand Hazard Ratio#=0.52

GRANITE Exhibits Favorable Tolerability Profile

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