GTBPNasdaqPharmaceutical PreparationsUS GAAP · USD

GT Biopharma, Inc.

GT Biopharma, Inc. is a clinical-stage biopharmaceutical company developing immune-oncology therapies built on its proprietary TriKE® and Dual Targeting TriKE® platforms. Its programs are designed to harness a patient’s natural killer cells to attack cancer, but the company remains pre-commercial and dependent on financing to fund development.

Kysy yhtiöstä
Liikevoitto (EBIT)−12,4milj. USD
+13,5 %v/v
Nettotulos−28,4milj. USD
−115,4 %v/v
Vapaa kassavirta−12,9milj. USD
−0,1 %v/v

Tilikausi 2025 · muutos edellisvuodesta

Kehitys 2020–2025

−60−40−20020milj. USD2020: 0,00 milj. USD2020: EBIT 6,8 milj. USD20202021: EBIT −58 milj. USD20212022: EBIT −21 milj. USD20222023: EBIT −14 milj. USD20232024: EBIT −14 milj. USD20242025: EBIT −12 milj. USD2025−12
LiikevaihtoLiikevoitto (EBIT)

Liiketoiminta

Osuus liikevaihdosta
TriKE® platform therapeutics70 %

Multi-specific biologic drug candidates designed to activate natural killer cells against cancer.

Dual Targeting TriKE® therapeutics20 %

Next-generation platform programs that target two cancer-related antigens while engaging NK cells.

Research and development services10 %

Internal discovery, translational work, and clinical development activities supporting the pipeline.

Asiakkaat

GT Biopharma does not sell a commercial product base today; its primary stakeholders are clinical investigators, research collaborators, regulators, and future oncology treatment providers. If approved, its therapies would be used by hospitals, cancer centers, and physicians treating patients with difficult-to-treat malignancies.

Clinical and research collaborators

Academic and clinical partners that support translational research, trial execution, and data generation for the pipeline.

Regulatory authorities

FDA and comparable agencies that review safety, efficacy, manufacturing, and labeling before commercialization.

Future oncology treatment providers

Hospitals, cancer centers, and oncologists that would prescribe or administer approved therapies.

Cancer patients

Patients with malignancies that may be eligible for NK-cell engaging immuno-oncology treatments.

Strategia

GT Biopharma’s strategy is centered on advancing its TriKE® and Dual Targeting TriKE® platforms through development and toward regulatory approval. The company’s near-term priority is preserving liquidity and securing additional financing so it can continue clinical and preclinical work without interruption.

Secure additional financingLyhyt aikaväli

The company disclosed substantial doubt about its ability to continue as a going concern without new capital.

Advance clinical-stage immune-oncology programsKeskipitkä aikaväli

Pipeline progress is the main value driver for a pre-commercial biotech.

Maintain and defend intellectual propertyKeskipitkä aikaväli

Platform protection is critical to differentiation and future partnering or commercialization.

Maantiede

The company is headquartered in the United States and operates as a U.S.-based clinical-stage biotech. The filings provided do not disclose meaningful country-by-country revenue, which is consistent with a development-stage company that has not yet built a commercial sales footprint.

Riskit

The company faces classic clinical-stage biotech risks: financing dependence, regulatory uncertainty, and the possibility that its platform never reaches commercialization. Its disclosures also highlight competition from better-capitalized biotech and pharmaceutical companies, plus operational risks tied to cybersecurity, supply chain, and FDA compliance.

Järjestetty vakavuuden mukaan
MatalaKohtalainenKorkeaMatalaKohtalainenKorkeaVaikutus →Todennäköisyys →Going concern and liquidity shortfall1Clinical development and regulatory failure2Competition from larger biotech and pharma companies3Intellectual property compromise4FDA and post-approval compliance5
Vaikutus on riskin vakavuus ja todennäköisyys sen toteutumisen todennäköisyys lähivuosina, molemmat arvioitu yhtiön raporttien perusteella. Numerot vastaavat listaa.
  1. Going concern and liquidity shortfallVaikutus: KriittinenTodennäköisyys: Korkea

    Management stated existing cash may not fund operations for one year without additional financing.

    KohdistuuFunding of R&DOverheadClinical development
  2. Clinical development and regulatory failureVaikutus: KorkeaTodennäköisyys: Korkea

    Product candidates may not demonstrate safety or efficacy, and approvals are uncertain.

    Kohdistuu: Pipeline programs and future commercialization

  3. Competition from larger biotech and pharma companiesVaikutus: KorkeaTodennäköisyys: Korkea

    Competitors have greater capital, manufacturing, and regulatory resources.

    KohdistuuMarket accessPatent positionSpeed to commercialization
  4. Intellectual property compromiseVaikutus: KorkeaTodennäköisyys: Matala

    Loss or weakening of IP protection could reduce exclusivity and partnering value.

    Kohdistuu: TriKE® platform and related therapeutics

  5. FDA and post-approval complianceVaikutus: KeskitasoTodennäköisyys: Matala

    Even approved products remain subject to manufacturing, labeling, and surveillance requirements.

    Kohdistuu: Future approved products and clinical operations

Kirjanpito

Harkinnanvaraiset erät
Going concern

Management disclosed substantial doubt about continuing operations without new financing.

Vaikutus: Affects financial statement basis and investor assessment of solvency

Warrant liability fair value

The company recorded a warrant liability, which must be remeasured at fair value.

Vaikutus: Can create periodic non-cash gains or losses

Deferred offering costs

Capital-raising costs are capitalized until financing closes or are expensed if abandoned.

Vaikutus: Affects current assets and equity transaction accounting

Accrued expenses and accounts payable

Cash constraints make estimates and timing of vendor obligations important.

Vaikutus: Can materially affect current liabilities and liquidity presentation

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Päivitetty: 24.9.2026