Moleculera Labs

Moleculera Labs was founded by Drs. Craig Shimasaki and Madeleine Cunningham in 2011, to medically understand and clinically identify the underlying biological root of neurological, psychiatric, and behavioral disorders. Similar to the emergence of the immuno-oncology connection, epidemiological and research evidence demonstrates that a largeportion of neuropsychiatric disorders are caused by an autoimmune dysfunction.
The Company owns and operates a fully accredited clinical laboratory with its first revenue generating product—a blood panel called the Cunningham Panel™ that detects brain and nervous system targeted autoimmune antibodies in patients with neurologic, psychiatric, and behavioral disorders triggered by an infection. Patients are diagnosed with PANS, PANDAS, autism spectrum disorder, ADD/ADHD, bipolar disorder, anxiety disorder, Tourette’s, obsessive compulsive disorder (OCD), schizophrenia, or other neurologic and psychiatric syndromes, whereas the root may be a dysfunctional immune response. Symptoms include OCD, anxiety, depression, psychosis, motor or vocal tics, verbal and non-verbal communication difficulty, deteriorating social skills, eating disorders, academic regression, and rage. These patients are typically prescribed neuropsychiatric drugs, often resulting in little or no improvement. However, once a patient is correctly diagnosed through testing, treatment is redirected towards the immune system, neuroinflammation, and subclinical infections, resulting in remarkable recoveries, sometimes after decades of suffering.

Moleculera is the sole clinical laboratory performing this panel covered by two U.S. patents. The Company has received and processed over 13,000 blood specimens ordered by over 1,700 physicians in over 50 countries, all prior to launching a sales force. The Company generated $1.1 MM in 2021 and is preparing to scale for revenue expansion with expectations of revenue ~$25 MM in 4-5 years. The company is now applying this technology to autoimmune cardiovascular disease and Long-COVID symptoms.

The basic research that led to the identification of these antineuronal antibody targets was studied for over 20 years in the laboratory of Dr. Madeleine Cunningham at The University of Oklahoma Health Sciences Center, with subsequent collaboration from the Pediatric Branch of the National Institutes of Mental Health (NIMH). Scientific and clinical results have been published in multiple top-tier peer-reviewed journals. Certain infections that have been found to trigger these autoimmune antibodies include strep, Lyme, mycoplasma, Babesia, bartonella, coxsackie virus, and others. Medical journals have reported an autoimmune response to SARS-CoV-2 (COVID-19), with approximately one-third of patients experiencing some neurologic or psychiatric symptoms.

The patented Cunningham Panel™ consists of five tests. Four which measure levels of autoantibodies directed against Dopamine D1 receptor, Dopamine D2L receptor, Lysoganglioside GM1, and Tubulin. A fifth test measures CaM Kinase II activation, a key enzyme involved in the production of neurotransmitters dopamine, epinephrine, and norepinephrine. Autoimmune antibodies that bind to these targets interfere with or block normal neurologic activity in the brain and nervous system. The laboratory results assist a physician in making a diagnosis and identifying the appropriate therapy. In addition to individual clinicians who order the panel, the Company has provided testing to over 80 medical institution customers.

In a 2020 publication in the Journal of Neuroimmunology, the Cunningham Panel demonstrated an 88% sensitivity and 92% specificity with an accuracy of 90% correlating these autoantibody elevations and neuropsychiatric symptoms before and after treatment. The Cunningham Panel aids a clinician’s treatment decision by directing them to the underlying subclinical infections and neuroimmune dysfunction, rather than simply treating symptoms. Effective treatments typically include various anti-infectives, anti-inflammatory agents and immunomodulators.

Moleculera’ s Test Panel generates an average realized revenue of $900 through existing CPT codes and patient billing. The Company has generated over $10 million in cumulative revenue since opening. During the COVID-19 pandemic, revenues for 2021 were $1.1 million, all prior to adding a sales force. Approximately 10% of orders come from a growing international market, with the Company receiving orders from over 1,700 clinicians. Moleculera Labs has one of the largest IRB approved and clinically annotated serum specimen biobanks of over 13,000 specimens utilized for research and development of new products for autoimmune neuropsychiatric disorders.

The Company has demonstrated its panel’s clinical utility in multiple neuropsychiatric disorders and have been able to predict treatment efficacy while working with pharmaceutical and research partners to assist in identifying novel drug targets. There is a clear unmet medical need and demand in this $23 billion dollar neuropsychiatric and behavioral disorder market. Moleculera recently in-licensed exclusive technology for multiple autoimmune antibody targets against the heart, which are implicated in a portion of multiple cardiovascular diseases such as heart failure, cardiomyopathy, atrial fibrillation, and myocarditis. With this technology along with proposed clinical studies and validation in process, the Company expects to develop and commercialize two additional panels. One panel will target various cardiovascular diseases (world-wide market of $4.9 trillion) infection-triggered autoimmunity, and another panel for diagnosing and treatment-monitoring of Long-COVID (estimated at $6.5 trillion). Our precision medicine business model is fashioned after Foundation Medicine and Genomic Health, whose precision medicine companies were acquired by Roche in 2018 for $5.3 billion, and Exact Sciences in 2019 for $2.8 billion, respectively.

Moleculera Labs is led by Dr. Craig Shimasaki, a serial entrepreneur with over 35 years of biotechnology experience, who began his career at Genentech. He co-founded multiple companies, participated in taking several companies public into the U.S. and the Canadian stock exchange, led five products through the FDA diagnostic approval process, and has directed two CLIA labs, raising over $30 million for these companies. Dr. Madeleine Cunningham, Chief Scientific Officer, is an internationally recognized leader in infection-induced autoimmune neuropsychiatric disorders and is a tenured professor at the University of Oklahoma with over 40 years of research and over 130 authored publications in leading scientific and medical journals. Dr. James Appleman is VP of R&D and Clinical Development and has 30+ years’ experience in building successful diagnostic and therapeutic companies from inception through successful exits, including a $230M exit to Roche. Mr. Fred Hiller is CFO and brings 45+ years’ experience in corporate finance and accounting. He began his career at Touche Ross & Co. in 1962, serving as controller at Elgin National and Columbia Pictures, and CFO at Wilkinson Sword. He has been a financial consultant to numerous companies including two biotechnology companies and one that was publicly traded.

Industry: Medical Research Center
Type: For Profit
Email: [email protected]
Phone: 14052395250
Founder: Craig Shimasaki, Madeleine Cunningham