Trethera

What Trethera does

Trethera Corporation is a clinical-stage biopharmaceutical company headquartered in Sherman Oaks, California and incorporated in Delaware, developing first-in-class small-molecule therapeutics targeting the nucleoside salvage pathway. The company's lead product, TRE-515, is an orally administered, once-daily small-molecule inhibitor of deoxycytidine kinase (dCK), the rate-limiting enzyme supplying deoxyribonucleotide precursors for DNA synthesis in rapidly dividing cells. TRE-515 exploits the selective dependency of cancer cells and aberrantly activated lymphocytes on the salvage pathway, while sparing healthy adult cells where dCK activity is minimal, yielding a broad therapeutic window demonstrated by a 36-fold dose escalation (40 mg to 1,440 mg daily) without dose-limiting toxicities. The company is also developing proprietary PET radiotracer probes (notably [18F]CFA) and plasma deoxycytidine assays as companion biomarkers for target engagement.

Trethera is advancing TRE-515 across oncology and autoimmune indications through a pipeline-in-a-product strategy, with completed Phase 1 solid-tumor data showing 47% disease control in heavily pretreated patients, expanded-access treatment in ALS showing disease stabilization, and preclinical programs across ADEM, optic neuritis, multiple sclerosis, lupus, Crohn's disease, and NSCLC. The FDA has granted four regulatory designations: Orphan Drug status for both ADEM and optic neuritis (7-year market exclusivity), and Fast Track status for prostate cancer in combination with both radiation therapy and Pluvicto. The company is led by CEO Johanna Holldack with Kenneth Schultz as Chairman of the Board, supported by founders from UCLA including Drs. Johannes Czernin, Caius Radu, David Nathanson, Michael Jung, Owen Witte, and Peter Clark.

Trethera is pre-revenue with no approved product; its business model is currently funded by non-dilutive NIH SBIR/STTR grants (over $12 million) and a $3.8 million seed round from existing investors, with a Reg D offering for accredited investors. TRE-515 is distributed exclusively through clinical trial sites and the FDA Expanded Access program. Future commercialization would rely on the compound's patent protection extending through at least February 2045 and the regulatory exclusivity conferred by Orphan and Fast Track designations.

Name

Trethera

Legal name

Trethera Corporation

Website

https://trethera.com

Company type

Private

Founded year

2020

Operating status

Operating

Headcount range

1–10 employees

Short description

Trethera is a clinical-stage biopharmaceutical company developing TRE-515, a first-in-class oral deoxycytidine kinase inhibitor, for solid tumors, prostate cancer, NSCLC, and autoimmune diseases including ADEM, optic neuritis, lupus, Crohn's disease, and ALS.

Ownership category

akta.pro rank

Product category

Clinical-Stage Biopharmaceutical Therapeutics

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Personalized Therapeutic Design (neoantigen vaccines, individualized cell/gene therapies) (HLAAANAK)

akta.pro secondary industries

Neurology & CNS Specialty Pharmaceuticals (HLAIACAC), Genetic & Genomic Rare Disease Therapeutics (HLAIAIAA)

Keywords

• Clinical-stage biopharmaceutical
• Oncology drug development
• Autoimmune disease therapeutics
• Nucleoside salvage inhibitors
• Small molecule drug discovery

Headquarters

HQ city

Beverly Hills

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations

Revenue model

1. Drug Commercialization (Future): Once TRE-515 receives FDA approval, Trethera plans to commercialize the drug for oncology and autoimmune indications. The company holds Orphan Drug designations for ADEM and optic neuritis (7 years marketing exclusivity), Fast Track designation for prostate cancer, and patents through at least 2045.
2. NIH Grant Funding (Non-dilutive): Trethera has secured over $12 million in NIH SBIR/STTR grants supporting preclinical and clinical development of TRE-515 across multiple indications (solid tumors, Crohn's disease, lupus, ADEM, NSCLC, prostate cancer). These non-dilutive grants reduce development risk and financial burden.
3. Exempt Securities Offering: Trethera filed a notice of exempt offering of securities (Reg D), raising capital from accredited investors to fund ongoing clinical operations and drug development.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels6 records

Core offering

Trethera develops TRE-515, a first-in-class, orally administered small molecule inhibitor of deoxycytidine kinase (dCK) that targets the nucleoside salvage pathway. The investigational drug is being advanced through Phase 1 clinical trials for solid tumors, FDA Expanded Access for ALS, and preclinical programs across multiple autoimmune diseases including ADEM, optic neuritis, multiple sclerosis, Crohn's disease, and lupus.

Product overview

Trethera is a clinical-stage biopharmaceutical company with a single lead product, TRE-515. TRE-515 is a first-in-class, orally administered dCK inhibitor capsule that targets the nucleoside salvage pathway, which becomes upregulated in cancer cells and activated immune cells. The company develops TRE-515 across multiple therapeutic areas: oncology (solid tumors, prostate cancer, NSCLC) and autoimmune diseases (ADEM, optic neuritis, MS, lupus, Crohn's disease, IBD), as well as neurodegenerative conditions (ALS). Trethera operates a pipeline-in-a-product strategy, advancing a single drug candidate across multiple indications.

Differentiator

Problem solved

Functional benefit

Products and services

• TRE-515 TRE-515 is an investigational, first-in-class oral deoxycytidine kinase (dCK) inhibitor capsule administered once daily, designed to treat solid tumors, autoimmune diseases, and neurodegenerative conditions by exploiting the nucleoside salvage pathway upregulated in diseased cells.

Quantifiable outcome

• 47% disease control rate (14/30 patients) with durability up to 342 days in heavily pretreated solid tumor patients
• +7 more outcomes

Named customers2 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Four partnerships are on record, tiered core.

• Massachusetts General HospitalcoreStrategic or Co-development Partner · 31 March 2026Clinical collaboration with Massachusetts General Hospital to evaluate TRE-515 in up to 6 patients with advanced ALS under the FDA Expanded Access program. Trial will assess safety, tolerability, and disease trajectory using ALSFRS-R, Slow Vital Capacity, and ALS biomarkers including neurofilament light chain. Builds on prior encouraging findings from a single advanced ALS patient treated last year showing disease stabilization and no adverse events attributable to TRE-515.
• University of California, Los Angeles (UCLA)coreStrategic or Co-development Partner · 3 June 2025Exclusive worldwide licensing agreement with UCLA Technology Development Group expanding TRE-515 intellectual property to include new therapeutic uses in autoimmune and inflammatory diseases. License includes method of use claims and compound structures, extending patent protection through at least February 2045. UCLA scientists (Dr. Peter M. Clark, Dr. Caius Radu, Dr. Johannes Czernin, Dr. Michael Jung, Dr. Owen Witte) founded Trethera and serve on its Scientific Advisory Board and Board of Directors. Multiple clinical trials conducted with UCLA investigators as principal investigators.
• Cedars-Sinai Medical CentercoreStrategic or Co-development Partner · 31 March 2025Cedars-Sinai collaborated with Trethera on treating a late-stage ALS patient under FDA Expanded Access. Dr. Frank Diaz, Assistant Professor of Neurology at Cedars-Sinai, served as treating neurologist. Patient achieved disease stabilization with improved lung function, strength, and no adverse events over a three-month treatment period with TRE-515.
• Providence Saint John's Health CentercoreStrategic or Co-development Partner · 31 March 2025Providence Saint John's Health Center collaborated with Trethera and Cedars-Sinai on the ALS Expanded Access patient case. Dr. Dan Kelly, President of the Pacific Neuroscience Institute Foundation at Saint John's Health Center, provided commentary on TRE-515's potential as an ALS treatment.

Scale indicators11 records

Recent moves7 records

Expansion highlights5 records

Direct peers

• Cogent Biosciences: Clinical-stage precision oncology company developing small molecule therapies for genomically defined diseases. Comparable to Trethera in company stage, lean team structure, single-asset focus on kinase/metabolic targets, and reliance on FDA designations and academic partnerships to advance a novel mechanism through Phase 1/2.
• Pliant Therapeutics: Clinical-stage biopharmaceutical company developing novel therapies for fibrotic and autoimmune diseases. Comparable in clinical stage, small-cap profile, single-mechanism platform with pipeline-in-a-product positioning, and similar reliance on academic founders and FDA designations (e.g., Fast Track, Orphan) to advance development.
• Keros Therapeutics: Clinical-stage biotech developing small molecule therapeutics targeting TGF-β superfamily for blood and immune disorders. Comparable in clinical stage, single-platform orientation, lean structure, and focus on indications with high unmet need. Both companies leverage non-dilutive NIH/grant funding alongside equity raises.
• Kymera Therapeutics: Clinical-stage immunology company developing targeted protein degradation (TPD) therapies for autoimmune diseases and cancer. Comparable in clinical stage, immunology/oncology dual focus, novel mechanism approach, and platform-oriented strategy for multiple indications.
• Black Diamond Therapeutics: Clinical-stage precision oncology company developing small molecule therapies against allosteric oncogenic mutations. Comparable in clinical stage, single-platform small molecule strategy, academic-founder origins, and pipeline approach leveraging a unified mechanism across multiple cancer indications.
• Arcus Biosciences: Clinical-stage immuno-oncology company developing small molecule and antibody therapies targeting adenosine and other metabolic pathways in cancer. Comparable in clinical stage, oncology/immunology dual focus, and emphasis on metabolic pathway inhibition—closely aligned with Trethera's nucleoside salvage pathway strategy.
• Tyra Biosciences: Clinical-stage precision oncology company developing small molecule kinase inhibitors for FGFR-driven cancers. Comparable in clinical stage, lean team structure, founder-led organization, single-mechanism platform strategy, and similar capital efficiency approach with focused indication selection.

Broad incumbents

• RayzeBio: Clinical-stage radiopharmaceutical company (acquired by Eli Lilly in 2024) developing actinium-based radioligand therapies for solid tumors. Highly comparable given Trethera's recent FDA Fast Track designation combining TRE-515 with Pluvicto (lutetium-177) for PSMA+ mCRPC, placing both companies at the radioligand + combination therapy intersection.
• MorphoSys: Established biopharmaceutical company (acquired by Novartis in 2024) specializing in autoimmune diseases and oncology with a pipeline of antibody therapeutics. Comparable to Trethera in autoimmune indication focus (lupus, MS) but operates at a much larger scale with multiple approved/commercialized products.

Others

• Schrödinger: Computational drug discovery platform company that licenses its physics-based software to biopharma and develops its own pipeline of small molecule therapeutics. Thematically related to Trethera as a small molecule-focused biotech, though structurally distinct as a platform/tools company rather than a single-asset clinical developer.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/trethera

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Funding overview

Funding rounds9 records

Investors6 records

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Trethera