Bach Pharma Newsletter

July 2020

Corporate Newsletter

July 2020| Issue 7

GVT & COVID-19 - Update

Bach personnel have reported that our Russian partner, through an independent Contract Research Organization (CRO) Victoria Pharm, LLC, has recruited almost 900 participants in an ongoing COVID-19 prevention trial with GVT . Recruitment will end July 31, 2020 and the study will be published by December. The CRO has initiated the study in 4 different sites in Moscow and St Petersburg so far. One site has over 250 Covid-19 Doctors and healthcare workers included in the trial.

GVT Study design for the treatment of patients with COVID is now in development and we are writing study synopsis. We plan patient recruitment in this study as soon as we receive regulatory approval.

As some of the current participants have compromised immune system issues, we are recording the participants known blood markers before, during and after the trial in both studies and we will report on information about concomitant diseases. Patients with liver diseases (AST/ALT >2 times higher normal range) are excluded from treatment study according to the approved study synopsis.

We are optimistic that these trials will progress our research on the effects of GVT on COVID-19.

Bach Pharma -

Gulf War Illness, IND, Strategy and Growth

We reported that Bach Pharma is pursuing an IND for Gulf War Illness and is in the midst of a $2.2M Capital Raise to reach that goal. Perhaps you are wondering - "What does all that mean and how will it affect the future growth of Bach Pharma?" In order for all of our Shareholders to better understand our goals, we want to break it down with a bit more detail:

IND - "Investigational New Drug" - The United States Food and Drug Administration 's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and allows the distribution of experimental drugs to clinical investigators before a marketing application for the drug has been approved.

Why start with GWI? - Bach Pharma is beginning the research with Gulf War Illness for a number of reasons. First, we believe that GVT will help millions of veterans around the world. One of the leading causes on Gulf War Illness is the exposure to chemicals during war and conflicts. Next, Bach Pharma has an $8M commitment from the Department of Defense for Clinical Trials. Finally, Bach Pharma's studies have shown that the data we collect from research and trials that we complete for GWI is connected to ALS.

What happens next? - Bach Pharma is dedicated to the utilization of monosodium luminol to treat multiple neurodegenerative diseases. While focusing on GWI, we plan on parallel research for COVID-19. By focusing on research, clinical trials and partnerships, we hope to broaden our scope and make our products available to patients around the world.

Spotlight on:

Daniel Cato, MS, MBA

Meet Daniel Cato, MS, MBA the Vice President of Regulatory Affairs for Bach Pharma

Mr. Daniel Cato has 30 years of experience in all phases of activities involved in the development and management of Clinical Trials. Mr. Cato was previously Director and Vice President of Project Operations for Cato Research Ltd., a Contract Research Organization (CRO) located in Durham, North Carolina. He was also the Managing Director for Cato’s Washington bureau, and was responsible for IT Strategy and Operations, Facilities, and Administrative Services. His close work with the Washington bureau has provided close contact and familiarity with the FDA and other Federal US agencies essential for the approval of new drug applications.

Mr. Cato learned the business from the ground up, starting as a computer technician developing early stage project plans, budgets and proposals for product development, Phase 1 through Phase 3 clinical trials, through to late stage clinical trial monitoring and analysis. He continued to direct and develop the overall networking plan for Cato Research including systems for internal operations of Finance, Human Resources, Network Operations and Business Development. Mr. Cato became managing director of their Washington DC metro office, and participated in all contract negotiations and helped plan for strategic growth of the company. He recently left Cato Research after the family owned company was bought out by a strategic investment partnership.

Mr. Cato currently works as a consultant to help other companies develop and bring their drug products to market. After previously serving at Bach Pharma, Inc. on the Board of Directors and as President, Mr. Cato continues to serve as the Vice President and the Director of International Regulatory Affairs and Science Advisory Board Director. With his extensive experience in pharmaceutical clinical trial management, systems, and knowledge of worldwide regulatory affairs, Mr. Cato brings the leadership necessary to complete Bach's international development goals.

Mr. Cato received his BS and MS in Electrical Engineering from North Carolina State University, Raleigh, North Carolina in 1991, and his MBA in 2009 from Duke University, Durham, North Carolina, Fuqua School of Business Global Executive Program, with an emphasis in health care.