GBS: Institutional Review Board Approval for Glucose

By John Vandermosten, CFA

NASDAQ:GBS

READ THE FULL GBS RESEARCH REPORT

GBS, Inc. GBS has received institutional review board (IRB) approval to enroll subjects for its time-course glucose evaluation study which will clinically validate the time course of glucose. Details were disclosed in a press release. The clinical trial will enroll approximately 40 subjects with type-2 diabetes and collect coincident samples of oral fluid and blood to evaluate the correlation between the two. The study entitled Specimen Collection Methodology to Support Subsequent Correlation Analyses of Glucose in Oral Fluids, Capillary, and Venous Blood is expected to begin enrolling first patients in the second quarter of 2022. Initial data from the effort is expected summer 2022.

GBS will be working with David C. Klonoff, M.D. as the principal investigator and enrollment will take place at the Diabetes Research Institute of Sutter Health's Mills-Peninsula Medical Center (MPMC) in San Mateo, California. The study will ensure sufficient distribution of age and sex among participants to ensure results are clinically valid. Collected samples will be evaluated by Quest Diagnostics DGX and the Department of Pathology at Johns Hopkins Hospital with additional samples frozen and evaluated later by other partners.

Glucose Biosensor Pre-Submission Package Filed with FDA

Last October, GBS announced that it had submitted its pre-submission package to the FDA to ensure that GBS' clinical plan is in line with the FDA's guidance. The pre-submission package will allowed the FDA to review GBS' next steps, including clinical trial protocols, and provide feedback to GBS on any perceived challenges. GBS is undertaking a three-step clinical plan that begins with the generation of prospective data that tracks both salivary and blood glucose and the time relationship between the two. Once the relationship between the saliva and plasma tests is established, the next phase will aim to develop the algorithm between the two then generate data for regulatory submission.

Diabetes Testing

An integral part of a diabetic's routine includes glucose testing. Blood sugar tests are required to ensure that levels are neither too high nor too low. Blood sugar levels of 200 or greater at any time and a fasting blood sugar level of over 125 indicate diabetes. Frequent testing for diabetics can help the individual manage their disease and select a diet and exercise that will reduce spikes in blood glucose levels. Diabetics and those prone to diabetes will normally test their blood glucose level at least once per day. Most individuals who test use a blood sugar meter which requires a lance, test strip and device. The lancet is used to prick the skin so that a small sample of blood is produced. The blood is placed on to the test strip which is then read by the blood sugar meter.

While blood tests provide point of care readouts and are a dramatic improvement over prior approaches, there are downsides. The test requires draw site cleaning and preparation, a painful prick to the skin which can lead to numbness and scarring over time and risk of soreness, swelling and bruising. Accuracy can be affected by atmospheric conditions, location of prick and the quality of test strips. With younger diabetics, the pain and fear of needles may make sample collection difficult. With the advent of organic thin-film transistor (OTFT) technology, greater levels of sensitivity now allow for non-invasive alternatives for sampling to be used for quantifying blood sugar. The cost of printed OTFT sensors is competitive with blood test strips and saliva samples address many of the challenges associated with blood testing.

Upcoming Milestones

➢ Upgrade existing fabrication facility - 1Q:22

◦ Equipment delivery – 2Q:22

➢ Secure site of manufacturing facility - 2Q:22

➢ Launch of plasma-saliva time-course correlation study – 2Q:22

➢ Initial batch of equipment ordered and finalized - April/June 2022

➢ Initial data from time-course correlation study – mid-2022

➢ Preliminary biosensor response study - 3Q:22

➢ Biosensor algorithm development - 4Q:22

➢ Saliva glucose sensor FDA/TGA submission – 1H:23

Initiating Coverage

We recently initiated coverage on GBS where we provide a review of saliva testing and the biosensor technology used to identify analytes in this medium. Included is a section discussing the OTFT technology and its commercial viability. GBS' technology is examined, including its anticipated manufacturing process of reel-to-reel printing. The report delves into the opportunity for antibody detection and identifies other clinical indications that GBS is pursuing.

Summary

GBS will soon start its time-course correlations study to measure the relationship between glucose levels in blood and in saliva. A tight correlation between the two measurements will be a strong pillar in the company's effort to develop its saliva glucose biosensor. Trial duration should be short with first patients enrolled in the second quarter and first results a few months later. We maintain our target price of $5.00 per share.

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1. Source: GBS March 2022 Corporate Presentation

2. Source: GBS March 2022 Corporate Presentation