PsiThera's $47.5M Launch: AI-Powered Oral Drugs Aim to Unseat Injectables

PsiThera's $47.5M Launch: AI-Powered Oral Drugs Aim to Unseat Injectables

With $47.5M and a veteran CEO, PsiThera is using its advanced AI platform to develop oral medicines for diseases long-dominated by injectable biologics.

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PsiThera's $47.5M Launch: AI-Powered Oral Drugs Aim to Unseat Injectables

WATERTOWN, Mass. – December 10, 2025 – The biotechnology landscape witnessed a formidable new player emerge today as PsiThera, formerly Psivant Therapeutics, officially launched with a substantial $47.5 million Series A financing. The company is not just another startup with a promising molecule; it represents a calculated convergence of seasoned leadership, significant venture backing, and a sophisticated computational platform aimed squarely at one of drug development's most sought-after prizes: creating oral medicines for diseases long managed by injections.

Led by newly appointed CEO Eric Shaff, the former chief of Seres Therapeutics, PsiThera is advancing a pipeline of small molecule drugs for immune and inflammatory (I&I) conditions. The financing, co-led by heavyweight investors Samsara Biocapital and Lightstone Ventures, with participation from its parent company Roivant and others, signals strong market confidence in PsiThera's strategy. The company is betting that its proprietary computational intelligence platform, QUAISAR™, can succeed where others have struggled, starting with the lucrative and clinically validated Tumor Necrosis Factor (TNF) superfamily of targets.

The Computational Engine: Inside QUAISAR™

At the heart of PsiThera’s strategy is its QUAISAR™ (QUantum, AI, and Structure-Activity Relationships) platform. This is not merely a screening tool but a deeply integrated discovery engine that combines quantum chemistry, molecular dynamics, and machine learning with dedicated supercomputing power. Its core innovation lies in its ability to model and predict the dynamic behavior of proteins—how they move, flex, and change shape in their natural biological environment. This approach stands in stark contrast to conventional, static methods that often miss the subtle conformational shifts crucial for drug binding and action.

This technology was born from the work of Dr. Woody Sherman, PsiThera’s Founder and Chief Innovation Officer, and the original architect of the platform during his time at Silicon Therapeutics and later Roivant Discovery. Dr. Sherman, a veteran of Schrödinger with over 100 peer-reviewed publications, designed QUAISAR™ to create a continuous feedback loop between computational prediction and real-world biophysical data. “Traditional drug discovery approaches have significant limitations when it comes to challenging targets where molecular motion plays a pivotal role,” Dr. Sherman noted in the company’s announcement. “The fusion of our proprietary predictive computational models and human feedback from drug hunters with deep domain expertise accelerates the discovery of new drugs.”

The platform's power is already being demonstrated. PsiThera reported advancing its lead program from the identification of a novel chemical hit to the lead optimization stage in just four months. This rapid cycle time, translating complex physics and AI insights into actionable drug design, is a critical advantage in the capital-intensive world of biotech. It suggests an ability to de-risk programs and accelerate timelines, which is highly attractive to investors and crucial for outpacing competitors.

Strategic Leadership and Blue-Chip Backing

The appointment of Eric Shaff as CEO is a clear strategic move to pair cutting-edge science with proven commercial and developmental expertise. Shaff recently steered Seres Therapeutics to a landmark achievement: the FDA approval and successful launch of VOWST™, the first-ever oral microbiome therapeutic. His experience in navigating the regulatory and commercial pathways for a novel oral therapy in a new class provides PsiThera with invaluable, real-world leadership. It’s a powerful signal that the company is built not just for discovery, but for development and market entry.

Shaff is joined by a team of industry veterans, including Dr. Sherman and Chief Scientific Officer Dr. Camil Sayegh, who contributed to the development of UCB’s ZILBRYSQ®. The composition of the Board of Directors further underscores the company's strategic positioning. It includes Christina Isacson of Lightstone Ventures as Chair, along with representatives from Samsara Biocapital and Roivant, ensuring that deep scientific, financial, and operational expertise guides the company's trajectory.

The investor syndicate itself speaks volumes. Samsara Biocapital is known for its fundamentally driven, long-term investments in life sciences, while Lightstone Ventures focuses on backing disruptive technologies. The participation of Eurofarma Ventures also points to a global strategic interest in PsiThera’s platform. This combination of specialized biotech VCs and corporate venture arms provides a robust financial foundation and a network of strategic partners.

Targeting a Multi-Billion Dollar Market Shift

PsiThera’s initial focus on the TNF superfamily is a bold and calculated decision. For decades, this class of targets has been the domain of blockbuster biologic drugs like Humira and Remicade, which together generate tens of billions of dollars annually for treating conditions like rheumatoid arthritis and Crohn's disease. While transformative for many patients, these injectable therapies come with the significant burden of subcutaneous injections or intravenous infusions, potential for immunogenicity, and high costs.

The market has long sought a convenient, effective oral alternative. An oral small molecule could dramatically improve patient quality of life, increase adherence, and potentially expand access. This unmet need represents a massive commercial opportunity, but the target has proven exceptionally difficult for small molecule approaches. Several companies, including Sanofi with its candidate balinatunfib, are exploring oral TNF inhibitors, validating the high interest in this space. However, none have yet reached the market, highlighting the scientific hurdles.

This is where PsiThera believes its QUAISAR™ platform provides a decisive edge. By understanding the dynamic nature of TNF proteins, the company aims to design novel small molecules with optimized properties for efficacy and safety that can succeed where previous attempts have fallen short. A successful oral TNF inhibitor would not just capture market share; it would fundamentally shift the treatment paradigm for a wide range of debilitating inflammatory diseases.

From 'Vant' to Vanguard: The Roivant Connection

PsiThera’s story is also a testament to the evolving business models in biotechnology. The company originated as Psivant Therapeutics, a spinout from Roivant Sciences, which had previously acquired the core technology platform with its $450 million purchase of Silicon Therapeutics in 2021. Roivant’s strategy has long been to build nimble, focused companies—or 'Vants'—around promising assets or platforms.

By spinning out PsiThera as a fully independent entity while retaining a stake as an investor, Roivant allows the company to operate with the agility of a startup while benefiting from an established technological foundation and a strong initial network. This model enables the focused execution needed to tackle such a complex scientific challenge. PsiThera is not starting from scratch; it is launching from a well-prepared platform, refined within the Roivant ecosystem and now capitalized to pursue its specific mission.

With a powerful computational engine, a leadership team that knows how to bring novel oral drugs to market, and the financial backing to fuel its ambitious pipeline, PsiThera is positioned as far more than just another AI-driven biotech. It represents a serious, strategic effort to solve a long-standing challenge in medicine and, in doing so, disrupt one of the most valuable therapeutic markets in the world.

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