BeyondSpring

BeyondSpring

BYSIPhase 3

BeyondSpring is dedicated to developing novel cancer treatments, with its core technology platform based on the small-molecule drug plinabulin, a selective immunomodulating microtubule-binding agent. The company's most advanced program is plinabulin for the prevention of chemotherapy-induced neutropenia (CIN), which has undergone Phase 3 clinical trials. BeyondSpring's strategy involves leveraging plinabulin's dual mechanism of action—protecting bone marrow and activating T-cells—to improve outcomes in cancer care and expand into broader immuno-oncology applications.

Market Cap
$65.8M
Employees
50-100
Focus
Biotech

BYSI · Stock Price

USD 1.600.62 (-27.93%)

Historical price data

AI Company Overview

BeyondSpring is dedicated to developing novel cancer treatments, with its core technology platform based on the small-molecule drug plinabulin, a selective immunomodulating microtubule-binding agent. The company's most advanced program is plinabulin for the prevention of chemotherapy-induced neutropenia (CIN), which has undergone Phase 3 clinical trials. BeyondSpring's strategy involves leveraging plinabulin's dual mechanism of action—protecting bone marrow and activating T-cells—to improve outcomes in cancer care and expand into broader immuno-oncology applications.

Technology Platform

Centered on plinabulin, a selective immunomodulating microtubule-binding agent (SIMBA) with a dual mechanism of action for bone marrow protection and immune system activation.

Pipeline Snapshot

7

7 drugs in pipeline, 3 in Phase 3

DrugIndicationStage
Plinabulin + Docetaxel + Placebo (matching plinabulin placebo)Non-Small Cell Lung CancerPhase 3
Pegfilgrastim + Plinabulin + Docetaxel, doxorubicin, and cyclophosphamide (TAC)Chemotherapy-induced NeutropeniaPhase 3
Docetaxel + Plinabulin (DP) + Docetaxel (D)Non-Small Cell Lung CancerPhase 3
Plinabulin + PegfilgrastimChemotherapy-induced NeutropeniaPhase 2
PlinabulinMultiple MyelomaPhase 2

Opportunities

The primary growth opportunity is the multi-billion dollar market for CIN prevention, where plinabulin's differentiated profile could capture significant share.
Additional opportunities exist in expanding plinabulin's use in NSCLC and other cancers as an immuno-oncology combination agent, and in out-licensing or partnering for ex-US commercialization.

Risk Factors

Key risks include the unresolved FDA Complete Response Letter for plinabulin in CIN, the high cost and uncertainty of further clinical trials, dependence on a single lead asset, intense competition from established G-CSFs, and the need for substantial additional capital to fund operations and potential commercialization.

Competitive Landscape

BeyondSpring's main competitors in CIN are Amgen's Neulasta and biosimilar G-CSFs. Its differentiation lies in plinabulin's dual mechanism aiming to reduce neutropenia and bone pain while potentially providing an anticancer immune benefit. In NSCLC, it competes with docetaxel monotherapy and other later-line regimens.

Company Info

TypeTherapeutics
Founded2010
Employees50-100
LocationNew York, United States
StagePhase 3
RevenuePre-revenue

Trading

TickerBYSI
ExchangeNASDAQ

Therapeutic Areas

OncologySupportive Cancer Care
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