Akagera Medicines Introduction to Strategy, Partners and Product Pipeline

Our partners include the National Institute of Health (NIH) / Vaccine Research Council (VRC), the Gates Foundation, the Center for Epidemic Preparedness Innovations (CEPI), Vanderbilt Medical School, Boston College, and Duke Medical School. Akagera Medicines’ policy is to pay a maximum of 25% indirect costs for research and development agreements.

Company History: AKAGERA Medicines was founded as a public private partnership (PPP) to develop Long Acting Injectables, novel liposomal formulations of antibacterial drugs, to treat tuberculosis and other neglected infectious diseases. The company was launched in 2018 in Kigali, Rwanda. It is well-funded, majority-owned by the people of Rwanda, registered as a Delaware corporation, and has laboratories in Boston and San Francisco. Akagera registered a 100%-owned subsidiary in Kigali in 2022 to do manufacturing and clinical trials. Founding board members and advisors include Ambassador Dr. Albrecht Conze, Dr. Paul Farmer, Dr. Donald Kaberuka, Dr. Patrick Migambi, and Dr. Anne Lenaerts.

Competitive Advantages:

1. AKAGERA Medicines developed and patent-protected a delivery system, a series of novel liposomal formulations of antibacterial drugs for treating infectious diseases. The mechanism of action (MoA) for this new class of infectious disease drugs is a long acting injectable and includes increased uptake of liposomal nanoparticles that contain potent, antibacterial drugs — into macrophages responsible for phagocytosis and subsequent slow and sustained release of the encapsulated drug.

2. Our ligand-directed vaccines target and bind to antigen-presenting immune cells such as dendritic cells, which reduces side effects, lowers toxicity, reduces costs, allows for multivalency, and improves efficacy.

3. Dr. Paul Farmer, PhD/MD, a University professor at Harvard Medical School and citizen of Rwanda, said we must “Put the power next to the problem.” Our company is majority owned and 100% controlled by the people of Rwanda through the Rwanda Social Security Board. All 14 million citizens of Rwanda have a stake in AKAGERA Medicines. Four out of the five board members are citizens of Rwanda. This keeps our company focused on solving the problems of Africa and other poor nations. This is not a constraint. It’s our greatest competitive advantage and an honor.

4.  The four core technologies to our vaccine technology platform are:

•  We can make ionizable lipids to a world standard.

•  We can make a targeting moiety to a world standard.

•  We can quickly construct the right mRNA molecule and integrate it with the lipid.

•  We have multivalent and multi-modality formulations that allow us to co-locate up to 7 mRNAs, and integrate a T cell and neutralizing antibody response.

Strategy, Product Scope, and Partners: Our strategy is to be vertically integrated in Kigali, Rwanda, where we can manufacture, do clinical trials, and distribution throughout all of Africa and beyond. We will have a narrow business scope, moderate product scope, and broad geographic scope, globally. Our portfolio will include neglected diseases that are structurally unattractive like Lassa Fever, and diseases that are structurally attractive, but technically difficult to achieve like HIV.

We are “an early stage, target lead” fully integrated company with our discovery operations in San Francisco and Boston. The company developed therapeutics for TB, NTMs, MRSA, and vaccine candidates for Tuberculosis, Lassa Fever, HIV, RSV, and Influenza. These initiatives are being developed in close partnership with THE GATES FOUNDATION, the National Institute of Health (NIH) – Vaccine Research Council (VRC), the Center for Epidemic Preparedness Innovations (CEPI), and the European Investment Bank.

Financials: We have a 2023 financial audit with an unqualified opinion and will have the results of the 2024 audit in the first half of next year. AKAGERA Medicines has no debt. It’s efficiency, leverage and liquidity ratios are strong. There is a multiyear runway even without anticipated infusions of non-dilutive and investor capital.

Risks and Mitigants: The largest risks are key person risk; the emergence of a disruptive, rivalrous, technology; regulatory changes; and the ability to attract and retain an increasing amount of talent in Rwanda. Mitigants include:

·  AKAGERA Medicines’ lead scientist and lead executive are longtime friends and collaborators. They are not financially motivated, their health is good, and they see this work as their highest cause.

·  The technology has broad protection (7 issued patents in the USA already, and 79 filings around the world); barriers to entry in this space are regulatory, manufacturing, ability to raise capital, and cost to manufacture. We are networked into the main research universities (i.e., Oxford, Harvard, Duke, Vanderbilt, UNC) and centers of science (NIH-VRC, CEPI, GATES). We remain vigilant.

·  United States regulatory framework (HHS/FDA) is entering a period of relative uncertainty. We have the advantage of working with European and African authorities, as well.

·  Our experiences is that elite scientists and businesspeople in the African diaspora view Rwanda as one of the most attractive places in Africa to work. We consistently receive connections and resumes from such folks. We speak to one or two each week.

The Optimization of Value:

Outline the optimization of value for patients – future generations – owners – the executive and science team.

A critical responsibility for the Board of Directors and management is the optimization of the value that’s created by AKAGERA Medicines for the benefit of patients, owners, the science and executive team members, and future generations (taxes to nations, disseminated knowledge, new companies, national reputation, etc.).

The value that the company can create can grow exponentially for years or decades to come. But at any point in time that value is finite and needs to be allocated to these four groups. Startup companies usually scramble to create value measured in the stock of knowledge, both explicit and tacit that is required to gain momentum, to grow the company, so that this optimization discussion can even take place. Ultimately, it must take place.

A recent management exercise amongst AKAGERA MEDICINES’ executives found that ranking and allocating 100 points over these four groups placed the majority value in favor of patients in low and middle income nations (LMICs), then future generations and owners, and finally the team. This unusual weighting is consistent with the company’s explicit moral purpose.

 SUMMARY of AKAGERA Medicines Strategy, Operations, and Assets

• Strategy: AKAGERA Medicines strategy is guided by moral purpose, based on clear competitive advantages, informed with analysis, addresses large unmet needs, and will compel global partners and caregivers.

• Operations: Decision rights are comprehensive and mutually exclusive, metrics of performance are explicit, and incentive systems are aligned. Governance is invested and attentive; arm’s length legal and accounting checks and balances are in place. Pre-clinical experiments were comprehensive and few, if any, were done “at risk”. The clinical development plan is realistic.

• Assets: The United States Patent and Trade Office (USPTO) characterized our intellectual property as “novel, and with wide industrial applicability”. Team averages 20 years in industry. Global trusted network of relationships includes Duke, Vanderbilt, Oxford, Harvard, Colorado State, the National Institute of Health, CEPI, the Gates Foundation, Institut Pasteur de Dakar, and the European Investment Bank. We anticipate infusions of non-dilutive and investor funds.