Investor Information

FINANCIAL ASPECTS — Laguna Diagnostics is raising $5 million in Seed Funding to support CAP/CLIA validated Laboratory Developed Tests (in collaboration with our Lab partner), strategic hires, and initiate our FDA clinical validation trial for FDA approval.

OVERVIEW — Laguna Diagnostics develops proprietary blood-based RNA gene biomarker tests for diagnosing and differentiating mental and psychiatric disorders. Our initial products, which are protected under two U.S. patents, will diagnose and differentiate schizophrenia (SZ) and bipolar disorder (BD) from psychiatrically healthy individuals, which is a critical unmet healthcare need. These tests have a particular emphasis on early detection in patients who are undiagnosed or misdiagnosed. Widescale adoption of our method will revolutionize the diagnosis and treatment of these disorders.

PROBLEM — Current diagnostic methods rely heavily on patient-reported symptoms and historical clinical observations by psychiatrists, typically over 1 to 3 years. The challenge is that SZ/BD symptoms overlap, which complicates the diagnosis. SZ is initially misdiagnosed 50% of the time, and BD 70% – a critical unmet need. 50% of all lifetime mental illnesses begin by age 14, 75% by age 24. Suicide is the 2nd leading cause of death in youths 10-14.

SOLUTION — Our rapid blood tests provide fast and more accurate diagnoses, enabling earlier intervention and reducing costs, ultimately leading to an improved quality of life for patients. Our test results are returned to the ordering physician in 'Days, NOT Years™. Our SBIR-funded Pivotal Clinical Trial, supported by the National Institute of Mental Health (NIMH), has confirmed the concept of the quantitative assay. Our innovative approach has identified stable trait, blood-based RNA gene biomarkers for lifelong psychiatric disorders that have utility in undiagnosed and misdiagnosed patients. Our Pivotal Clinical Trial, conducted with 90 patient subjects at three-time points, demonstrated the effectiveness of our RNA gene panel in diagnosing schizophrenia and bipolar disorder. The results demonstrated high selectivity and sensitivity, both exceeding 95%, with an accuracy of 93%, effectively differentiating between SZ and BD populations, further validating our technology. The total available US market is ~2.2 million patients per year, with a total market value of ~$3 Billion.

TECHNOLOGY & PRODUCTS — Our methodology allows for the objective diagnosis of SZ and BD with the potential to detect these conditions one to two years before a first psychotic episode. Our methods can be applied to all other mental illnesses, as well as to military, law enforcement, and other critical screening areas. Early detection of a mental disorder also enables rapid interventions, especially in younger populations, with significant potential for impact on patients’ outcomes and families.

BUSINESS MODEL — We plan to commercialize our diagnostic and differentiating quantitative assay through a licensed CLIA-certified laboratory partner. We are pursuing additional grants and funding to support a larger validation clinical trial for FDA approval. These efforts will collectively enhance the company’s value in preparation for a future liquidity event.

PEOPLE — Laguna’s founders are M Marquis P. Vawter, Ph.D., Research Professor of Psychiatry and Director of the Functional Genomics Laboratory at the University of California, Irvine, and Terry W. Osborn, Ph.D, MBA, Dr. Osborn brings extensive executive leadership experience in managing startups and turnarounds within the healthcare industry.

SEED FUNDING — Laguna Diagnostics seeks to raise $5 million in seed funding to support CAP/CLIA Laboratory Developed Tests (in collaboration with our Lab partner), strategic hires, and initiate our FDA clinical validation trial for FDA approval.