Exclusive worldwide agreement adds human cellular validation to Lunai’s AI-driven Parkinson’s workflow, connecting patient-derived subtypes with disease mechanisms, biomarkers and therapeutic targets

SACRAMENTO, Calif., Sept. 22, 2026 /PRNewswire/ — Lunai Bioworks, Inc. (Nasdaq: LNAI), a biology-first AI drug discovery company, today announced an exclusive worldwide license and collaboration agreement with Tanaist, Inc. that adds human cellular phenotyping to Lunai’s growing Parkinson’s disease discovery and validation platform. The collaboration is designed to connect patient subtypes identified by BioSymetrics, Lunai’s wholly owned subsidiary, using its Augusta AI platform with independent patient cohorts and measurable human cellular biology.

Under the agreement, Lunai has exclusive rights to Tanaist’s licensed cellular phenotyping technology in the Parkinson’s disease field for programs based on Lunai’s patient phenoclusters. The companies plan to evaluate whether Lunai’s clinical and proteomic signatures can be reproduced across agreed Parkinson’s cohorts and connected to measurable differences in human cellular biology. The work is intended to test the robustness and generalizability of the subtype framework and prioritize biomarkers and therapeutic targets for further development.

Tanaist’s precision-medicine platform combines patient data with dynamic human cellular phenotyping to uncover biological differences that may be difficult to detect through conventional clinical data alone. The scientific approach underlying the platform has been demonstrated in peer-reviewed research published in Nature Genetics and Science Translational Medicine, including work linking human cellular phenotypes to genetic mechanisms, disease biology, and potential therapeutic targets.

The Tanaist collaboration represents the latest step in Lunai’s broader Parkinson’s strategy, which combines AI-based analysis of longitudinal patient data with complementary experimental validation systems. Together with Lunai’s August 2026 collaboration with BrainStorm Therapeutics, the company is building multiple independent paths to test which AI-derived disease signals are reproducible, biologically meaningful and actionable for therapeutic development.

Lunai previously analyzed longitudinal clinical information and more than 4,500 proteomic probes from more than 650 participants in the Parkinson’s Progression Markers Initiative (PPMI). The analysis identified three clinically distinct Parkinson’s subtypes associated with different patterns of disease progression. The next phase of the program will examine whether those findings can be reproduced across additional cohorts and whether the observed clinical and proteomic differences correspond to distinct cellular mechanisms. Establishing that connection is an important step toward determining whether the subtypes can support patient enrichment, biomarker development, and therapeutic target selection.

“Our initial analysis identified three clinically distinct Parkinson’s subtypes and generated specific hypotheses about the biology associated with different disease trajectories,” said David Weinstein, Chief Executive Officer of Lunai Bioworks. “The next questions are whether those findings are robust, whether they can be reproduced across additional cohorts, and whether they correspond to different underlying biology. Tanaist gives us a way to investigate those questions directly using human cellular models and patient-linked data.”

Advancing From Patient Stratification to Biological Validation

The three Parkinson’s subtypes identified by Augusta were characterized by fast motor progression, rapid neurological and cognitive decline, and female-enriched functional impairment. The work linked baseline clinical and proteomic characteristics to later disease progression over a median follow-up of approximately 2.5 years, with many participants followed for more than five years. Planned studies will provide orthogonal validation across retrospective patient cohorts, cellular phenotypes and data modalities, informing future prospective validation.

The agreement provides a framework for Lunai’s Parkinson’s classifiers, biomarkers and therapeutic hypotheses to be evaluated using Tanaist’s available retrospective Parkinson’s cohorts and human cellular phenotyping capabilities. Individual studies will be conducted under agreed Statements of Work and applicable data-use requirements, with Lunai owning collaboration-generated analyses, biomarker findings and other results as provided under the agreement.

“Lunai’s work begins with clinically defined patient populations and asks whether their different disease trajectories reflect distinct underlying mechanisms,” said Dr. Calum MacRae, Co-Founder at Tanaist. “Our platform provides a complementary biological lens through which those classifications can be tested. By integrating longitudinal patient outcomes with dynamic human cellular phenotypes, we aim to evaluate which signals are reproducible, mechanistically meaningful, and most relevant to therapeutic development.”

Building an Integrated Parkinson’s Discovery and Validation Platform

Together, Lunai’s computational and experimental capabilities are designed to create a path from patient stratification through biological validation to biomarker and therapeutic target development. Under the agreement, Lunai will own the collaboration-generated results and intellectual property, while Tanaist retains ownership of its underlying platform.

“Across our discussions with pharmaceutical leaders, the message has been consistent: patient stratification becomes valuable to drug development when it is reproducible, biologically grounded and capable of informing decisions about biomarkers, targets and patient selection,” said Dr. Gabe Musso, Chief Scientific Officer at BioSymetrics. “We have been deliberately building the validation capabilities needed to answer those questions. Tanaist adds human cellular biology to gate the development process, and represents an important next step in moving our Parkinson’s findings from computational discovery toward therapeutic application.”

About Lunai Bioworks

Lunai Bioworks, Inc. (NASDAQ: LNAI) is a biology-first AI drug discovery company applying advanced analytics and translational models to identify disease subpopulations, biomarkers and therapeutic opportunities. Through its BioSymetrics subsidiary, Lunai operates the Augusta AI platform across complex neurological and other diseases. For more information, visit www.lunaibioworks.com. 

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding Lunai’s Parkinson’s disease program, the Tanaist collaboration, biomarker development and validation, therapeutic target prioritization, potential pharmaceutical partnerships, and therapeutic and diagnostic development. Forward-looking statements are based on current expectations and assumptions and involve known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied. These risks include challenges in reproducing computational findings in cellular systems, risks inherent in biomarker and therapeutic development, risks in translating discoveries into pharmaceutical partnerships, regulatory risks, competitive risks, and other factors described in Lunai Bioworks’ filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. Lunai Bioworks undertakes no obligation to update or revise forward-looking statements except as required by law.

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SOURCE Lunai Bioworks Inc.