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One-carbon Therapeutics secures $16.2 million to accelerate phase 1/2 trials of first-in-class cancer therapy TH9619

The new investment accelerates development of a potential breakthrough therapy targeting the one-carbon metabolic pathway.
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Solna, Sweden, December 1, 2025: One-carbon Therapeutics AB, a clinical-stage biotechnology company pioneering first-in-class cancer therapies that target the one-carbon metabolic pathway, today announced the closing of an oversubscribed SEK 153 million (USD 16.2 million) private placement financing. The round included strong participation from both existing and new investors, including several Swedish family offices.

The proceeds will reinforce the company’s financial position and enable expansion of its ongoing Phase 1/2 ODIN clinical study of TH9619, a first-in-class dual MTHFD1/2 inhibitor. This financing follows the recent milestone of dosing the first subject in the ODIN study — marking One-carbon Therapeutics’ successful transition from a preclinical to a clinical-stage company. The trial is currently being conducted across leading academic and clinical research centers in the UK, France, and Spain, with expansion planned across additional European sites in the coming months.

“We are very encouraged by the strong confidence and enthusiasm shown by our existing and new investors, who recognize the potential of our lead asset. Their support is crucial for securing rapid execution and delivery of the potential new therapy to patients in need,” said Ana Slipicevic, CEO of One-carbon Therapeutics.

Slipicevic told DDN, “TH9619 targets a metabolic pathway that cancer cells heavily rely on. Cancer cells upregulate MTHFD1/2 to produce nucleotides — the DNA building blocks required for uncontrolled growth. These enzymes are overexpressed in most cancers, making tumor cells far more dependent on this pathway than healthy tissue.”

She explained that unlike traditional chemotherapy, which broadly damages dividing cells, TH9619 is designed to exploit oncogenic MTHFD1/2 activity. It kills cancer cells through a dual mechanism: (1) inhibiting MTHFD1 traps folate, causing thymidine depletion, and (2) inhibiting nuclear MTHFD2 disrupts DNA damage-response and repair pathways. In preclinical models, TH9619 effectively eliminates tumor cells while sparing healthy tissue. One-carbon Therapeutics are the first to present this mechanism, and "we believe it has the potential to become a breakthrough treatment for patients in need."

While Phase 1 oncology trials often enroll “all-comers,” One-carbon Therapeutics has taken a more targeted approach in the ODIN study. Based on published research and internal preclinical data, the company has intentionally selected tumor types with high MTHFD2 expression and significant unmet need in the refractory setting. The ODIN study therefore focuses on colorectal cancer, non–small cell lung cancer, head and neck squamous cell carcinoma, gastric cancer, and gastroesophageal junction cancer.

In parallel, the company is advancing a biomarker strategy to support future patient selection. One-carbon Therapeutics is collecting biological samples from all enrolled patients, enabling retrospective analyses of biomarkers and metabolites related to one-carbon metabolism.

“Based on the ongoing pre-clinical work, we have identified the most promising biomarkers and are in discussions with experts in the field." Slipicevic told DDN. "We are securing biological samples from all our patients. These samples will then be analyses retrospectively. Based on such analyses, we may include biomarker selection criteria into Phase 2 to further select patients with the highest likelihood of response."

One-carbon Therapeutics also extends its appreciation to clinical and academic collaborators, partners and advisors for their continued trust and partnership, and for their belief in our vision and science. Their support has been instrumental in driving the company’s scientific and clinical progress, enabling the advancement of TH9619.

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