Stock Analysis & Valuation GT Biopharma, Inc. (GTBP.PA)

• Previous Close: €280.50
• Sector Valuation Confidence Level: High

Valuation method	Value, €	Upside, %
Artificial intelligence (AI)	n/a	n/a
Intrinsic value (DCF)		n/a
Graham-Dodd Method		n/a
Graham Formula		n/a

Strategic Investment Analysis

Company Overview

GT Biopharma, Inc. (GTBP.PA) is a clinical-stage biopharmaceutical company specializing in immuno-oncology therapies using its proprietary Tri-specific Killer Engager (TriKE) platform. Headquartered in Brisbane, California, and listed on Euronext Paris, GT Biopharma focuses on developing innovative treatments for cancers such as myelodysplastic syndromes, acute myeloid leukemia (AML), and solid tumors. Its lead candidate, GTB-3550, is in Phase I/II trials targeting CD33+ malignancies, while GTB-3650 and GTB-5550 are in preclinical development for myeloid leukemias and B7-H3 positive solid tumors, respectively. The company leverages strategic partnerships, including collaborations with Altor BioScience and the University of Minnesota, to advance its TriKE technology. Operating in the high-growth biotechnology sector, GT Biopharma aims to address unmet needs in oncology with its novel immune cell engager therapies, positioning itself as a potential disruptor in cancer immunotherapy.

Investment Summary

GT Biopharma presents a high-risk, high-reward opportunity for investors focused on immuno-oncology innovation. The company’s TriKE platform offers a differentiated approach to cancer treatment, with GTB-3550 showing promise in early-stage trials. However, as a pre-revenue entity with negative EPS (€-6.94) and operating cash flow (€-12.9M), GT Biopharma’s valuation hinges on clinical success and partnership milestones. The lack of debt (€0) and €3.95M in cash provide limited runway, likely necessitating further capital raises. Investors should weigh the potential of its pipeline against the inherent risks of clinical-stage biotech, including trial delays and competitive pressures in the CD33 and B7-H3 targeting space.

Competitive Analysis

GT Biopharma’s competitive edge lies in its TriKE platform, which aims to enhance natural killer (NK) cell efficacy with tri-specific targeting—a niche approach compared to dominant bispecific antibodies or CAR-T therapies. Its focus on CD33 (GTB-3550/3650) and B7-H3 (GTB-5550) targets places it in direct competition with larger biotechs developing similar modalities. While the TriKE platform’s modularity could offer manufacturing and scalability advantages, GT Biopharma lacks the resources of established players, relying heavily on partnerships for development. The company’s clinical progress trails competitors like ImmunoGen (IMGN) in CD33-targeting therapies, and its B7-H3 program faces rivals such as MacroGenics (MGNX). GT Biopharma’s success depends on demonstrating superior efficacy/safety in trials and securing additional collaborations to offset its financial constraints.

Major Competitors

• ImmunoGen (IMGN): ImmunoGen is a leader in CD33-targeting therapies, with its antibody-drug conjugate (ADC) Elzonris approved for blastic plasmacytoid dendritic cell neoplasm. Its robust ADC platform and commercial capabilities outpace GT Biopharma’s early-stage efforts. However, ImmunoGen’s focus on ADCs (vs. GT’s TriKEs) presents a different risk/benefit profile, with potential for GTB-3550 to offer improved safety.
• MacroGenics (MGNX): MacroGenics develops B7-H3-targeting therapies, including the ADC MGC018 in Phase II, directly competing with GTB-5550. Its diversified pipeline and partnerships (e.g., Incyte) provide financial stability, but GT Biopharma’s TriKE approach could differentiate in efficacy if preclinical data translates clinically.
• bluebird bio (BLUE): bluebird bio’s gene therapies for AML (e.g., lovo-cel) represent a long-term competitive threat. While GT Biopharma’s off-the-shelf TriKEs avoid gene therapy complexities, bluebird’s established R&D infrastructure and FDA-approved products (e.g., Skysona) give it a commercialization edge.
• Novartis (NVS): Novartis dominates the CAR-T space (e.g., Kymriah) and has AML programs targeting CD33. Its global scale and resources dwarf GT Biopharma’s, but Novartis’ focus on autologous therapies leaves room for GT’s off-the-shelf TriKEs in niche indications.