Moleculera Biosciences is pioneering the diagnosis, treatment, and monitoring of immune-related neuropsychiatric, cardiovascular, Long-COVID, and neurodegenerative disorders. The complexity of immune-mediated chronic conditions has placed an enormous burden on the healthcare system, which is at the core of the future of human health. We enable clinicians with technologies needed to accurately diagnose, treat, and monitor patients suffering from certain chronic debilitating disorders to experience remarkable recoveries.
Globally, more than one billion individuals suffer from neuropsychiatric and mental health disorders, which has led to an increased demand for medical help. Approximately 77 million individuals in the U.S. are on antidepressants, anti-anxiety, antipsychotics, and mood stabilizers, and 30% to 60% are treatment-resistant to these drugs. A growing body of medical evidence has demonstrated that inflammation and immune dysfunction are a root cause of a high percentage of neuropsychiatric disorders such as schizophrenia, ADHD, OCD, autism, anxiety disorder, chronic depressive disorders, PANS/PANDAS, and many others. Moleculera Biosciences is at the forefront of precision medicine and has identified that many chronic disorders have a root cause of inflammation and immune dysfunction. These include certain neuropsychiatric disorders, cardiovascular disorders, Long-COVID, and Alzheimer's and Parkinson's disease. We are a spin-out from the research laboratory of Dr. Madeleine Cunningham at the University of Oklahoma Health Sciences Center, based upon over 20 years of research in immunology. Our first product is a patented Autoimmune Brain Panel of five novel biomarker blood tests that identify autoantibodies attacking neurologic receptors in the brain. Once correctly diagnosed, patients experience remarkable recoveries when treated with anti-inflammatory, anti-infective, and immune-modulatory drugs. We plan to launch our Autoimmune Cardiovascular blood panel in early 2026 and follow on with a Long COVID panel and an Early-Onset Alzheimer's Panel. Simultaneously, we have built one of the largest biorepository and bioinformatics of immune-mediated neuropsychiatric disorder specimens and patient data, and we are identifying novel biomarkers and therapeutic targets from these repository specimens.
We have multiple decades of experience in entrepreneurial biotechnology companies. Craig Shimasaki, PhD, MBA, Cofounder & CEO 35 years of biotechnology industry experience, beginning at Genentech, multiple start-ups, several taken public. Led 5 products through FDA approval. Author of Biotechnology Entrepreneurship: Leading, Managing, and Commercializing Innovative Technologies (2nd Ed). Madeleine Cunningham, PhD, Cofounder & CSO 40 years of research in molecular mimicry and immunity, 120+peer-reviewed publications. James Appleman, PhD, VP R&D & Clinical Development 35 years of therapeutic, diagnostic with successful exits, including a $230M exit to Roche Joseph M. Quashnock, Ph.D., HCLD/CC(ABB), FAACC, Clinical Laboratory Director 40 years CLIA clinical laboratories, PerkinElmer Genomics Diagnostics & Pediatrix Fred Hiller, Chief Financial Officer 45+ years experience in corporate finance and accounting and biotech companies Sean McCormick, MD, Director of Medical Affairs - Consultant 15 years experience improving quality, value, and access in healthcare. Five years as a physician in Clinical Informatics at Epic
Our Go-to-Market strategy consists of six components demonstrating traction in some of our testing facets: 1) Marketing Channels: awareness and education to clinicians and patients generating warm leads for follow-up; Educational Email Campaigns to physician database; Educational Webinar Series; Podium presentations at Targeted Medical Conferences with company exhibiting; expansion of Social Media Strategies; Leverage website and Patient Quiz to drive traffic to testing. 2) Commercial Sales Team: addition of an entire commercial sales team; addition of Clinical Science Liaisons focused on educating practicing physicians; Leverage Institutional Laboratories and Hospital Accounts; Addition of Internal Sales Support focused on outbound calling. 3) Marketing Partners & Patient Advocates: Leverage cross-selling and education through downstream partners; Expand International Marketing Partners; Patient Advocates for legislative bills mandating coverage for testing and treatment. 4) Medical Relations Support: Nurses and Medical Personnel Providing Consultative and Results Interpretation Guidance; Regional Physician Practice Management Calls; Key Opinion Leader Meetings and Presentations. 5) Reimbursement Strategy: existing CPT Codes for medical reimbursement; Pharmacoeconomic study for publications showing cost-effectiveness of early testing; Working on Contracting and Credentialling with 3rd party payors so patients would only have a co-pay. 6) Publications and Clinical Studies: Key publication strategy showing utility of testing for each of the disorder categories Case series before and after treatment; Clinical Studies with outside collaborators, pharma and IVIG manufacturers. Our partnerships include IVIG Infusion companies Soleo Health, Quest Diagnostics for blood collection and future sales support; multiple international partners for marketing specimen transport; working on a potential partnership with Cleaveland Clinic.
We have multiple sources of revenue generation. The first is through our molecular diagnostics testing panels; our Autoimmune Brain Panel is already in commercialization and generating revenue. We won a $500K grant beginning January 2025 for clinical validation of our Autoimmune Cardiovascular Panel (myocarditis, A-fib, cardiomyopathy, heart failure). We won another $500K grant to develop an AI treatment predictive algorithm for our Autoimmune Brain Panel. We have generated revenue from our biorepository and testing for Pharma for potential clinical studies and possible repositioning of their existing drugs for treatment of other indications.
We are seeking a $25MM Series A Preferred funding to expand the franchise we are building in immune-mediated chronic disorders. We have raised approximately $10MM over the years from multiple angel investors who have invested multiple times in each of our rounds. We are now moving to our first institutional round to grow, scale, and launch additional products and add a commercialization team. We have generated over $12MM in cumulative revenue over the years without a sales team while we established the foundation of the company, published papers demonstrating the value of our panel, and demonstrated there is a demand and that patients recover when correctly diagnosed and treated for an underlying immune-mediated disorder. The use of proceeds include: 25% to sales and marketing to our target specialist physicians and institutions to increase prescriber accounts and increase global revenue through panel uses and benefits. 20% to scale our clinical and research laboratory infrastructure, reduce our cost-of-goods and operations costs, and expand our CLIA/COLA accredited High Complexity Clinical Laboratory. 20% to Medical support, development, and publication of clinical case studies and treatment studies. 10% to insurance reimbursement and completion of pharmacoeconomic models demonstrating cost-savings to insurance companies when patients are diagnosed early and treated. 25% to new product development and product enhancement for our treatment algorithm, validate and launch autoimmune cardiovascular and Long-COVID panels and early onset Alzheimer's panel, expand autoimmune neurobiology testing applications, complete three targets for theraputic identification from biobank and work on out-licensure.
Our Advanced Platform consists of three inter-related business model components: 1. Molecular Testing: Our precision medicine blood panels uniquely detect autoimmune antibodies against novel disease biomarkers, providing critical insights for personalized treatment. Our Autoimmune Brain Panel of five brain receptor targets is in commercialization and has been clinically used by over 2,500 clinicians, testing over 15,500 patients in over 50 countries, all without a salesforce. We have generated $1.2MM in revenue in 2024 and utilize medical insurance CPT codes to support medical insurance billing for patients. 2. Biorepositories: Our robust bioinformatics and AI-driven treatment algorithms are underpinned by an extensive data collection framework, enabling data-driven decision-making. We have stored over 15,000 clinically annotated specimens for immune-mediated neuropsychiatric disorders, with patient data, symptoms, and treatment annotated information. We have been awarded a $500K grant to support creating an AI predictive treatment algorithm that would alleviate the trial-and-error treatment process once a patient is correctly diagnosed with these disorders. 3. Biomarker and Targeted Therapy Discovery: Our biorepositories provide us with a unique insight into the biology of these disorders and provide for the discovery and commercialization of new biomarkers of disease. Simultaneously, through our partnerships with research organizations, we are identifying novel therapeutic targets for immune-related diseases and are pioneering innovative treatment approaches.
$10MM in angel funding and $1MM in grants
