On May 8, 2025 HAYA Therapeutics, SA, a biotechnology company pioneering precision RNA-guided regulatory genome targeting therapeutics that reprogram disease-driving cell states for rare, common, chronic and age-related diseases, reported that the company has raised $65 million in Series A funding (Press release, Haya Therapeutics, MAY 8, 2025, View Source [SID1234652791]). The financing will accelerate the clinical development of HAYA’s lead long non-coding RNA (lncRNA) targeting candidate HTX-001 in heart failure and the continued expansion of its RNA-guided regulatory genome pipeline development engine. This investment emphasizes investor confidence in HAYA’s groundbreaking science and positions the company to deliver on its mission of bringing disease-modifying, precision medicines faster and more efficiently to patients. The round was led by Sofinnova Partners and Earlybird Venture Capital, with participation from Eli Lilly and Company (Lilly), ATHOS, +ND Capital, Alexandria Venture Investments and LifeLink Ventures, with additional support from existing investors Apollo Health Ventures, Longview Ventures (an affiliate of Broadview Ventures), 4see ventures, BERNINA Bioinvest and Schroders Capital.
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"This is a defining moment for HAYA as we are advancing our lead program into the clinic. This funding validates our organization, pioneering approach and vision for improving the way chronic and complex diseases are treated by creating a new generation of therapies that reprogram disease-driving cell states into healthy ones," said Samir Ounzain, Ph.D., Co-founder and CEO of HAYA Therapeutics. "We’re excited that Sofinnova Partners, Earlybird and our syndicate of investors share our vision for the potentially industry changing nature of our platform as we move beyond traditional approaches by leveraging novel therapeutic targets emerging from the regulatory genome."
The company will use the funds to initiate clinical trials for HTX-001, HAYA’s first-in-class lncRNA-targeting therapy for heart failure, initially focused on non-obstructive hypertrophic cardiomyopathy (nHCM). In parallel, the company will strengthen its platform capabilities and expand its pipeline of disease-modifying therapies across multiple therapeutic areas—including pulmonary fibrosis, obesity and age-related common and chronic diseases.
"HAYA’s platform unlocks the dark genome’s therapeutic potential by targeting disease-driving cell states via long non-coding RNAs. This novel approach opens a new frontier in precision medicine, moving beyond traditional target classes to address disease at its epigenetic and cellular roots. Leading this round alongside Earlybird reflects our deep conviction in the HAYA team and their mission to develop safer, more effective therapies across a broad range of indications, including their lead program in nHCM, as they advance it toward the clinic to address a major unmet need," noted Henrijette Richter, Managing Partner at Sofinnova Partners.
The core of HAYA’s proprietary platform maps and decodes the biology of the regulatory genome, also referred to as the "genome’s dark matter" or "Dark Genome," which constitutes 98% of the human genome. While the regulatory genome does not code for proteins it is now recognized as the master control layer of gene expression and cell identity. HAYA has developed the most comprehensive atlas of the regulatory genome by combining integrated multimodal functional genomics with a stack of proprietary computational and machine learning methodologies, enabling the precise identification and modulation of pathogenic cell states across diverse diseases. HAYA’s regulatory genome platform enables the development of RNA-guided therapeutics with unprecedented precision, speed and scalability. This next-generation approach is designed to go beyond symptom management and directly reprogram the cellular drivers of disease.
To support its strategic growth, HAYA recently assembled an industry-leading C-level suite to drive scalable growth, business and clinical development and expand strategic collaborations with pharmaceutical and technology partners. The company recently announced a partnership with Lilly, one of the largest collaborations to date in the regulatory genome space, focused on RNA-based drug targets for obesity and metabolic disorders.