Market Opportunities

There is a desperate and unmet need in finding an effective therapy against the SARS-CoV-2 coronavirus, that is responsible for the worst global and ongoing pandemic witnessed over the last century.
Despite the initial success with numerous vaccines that are currently in clinical use, , there is now a rising tide of vaccine resistant strains, vaccine hesitancy, large parts of the third world unvaccinated and unknown but limited duration of antibody protection. We are again seeing infective waves or surges for multiple reasons, the most threatening being immune escape from emerging new variants Delta, Delta+ and newer variants such as the Omicron that is soon likely to be the most ubiquitous form.
The alternative of relying on sufficient natural herd-immunity implies the tacit acceptance of considerably more than the current 690 million cases and 6.9 million deaths worldwide with over 100 million cases and over 1 million deaths in the USA. These numbers are thought to be underestimated by a factor of x2 – x4.
We strongly believe the best approach is to develop an effective anti-viral strategy that can be used not only to treat COVID-positive individuals, regardless of their symptomatic status, but that widespread use of this therapy as a prophylactic drug would dramatically limit the spread of infection and allow global societies to return to normality in a shorter period.
Even as new vaccines are developed, immunity is not expected to be lifelong and unlikely to be 100% protective. The market is therefore a massive global one that is unlikely to disappear within the next 6 months and most likely to revisit every year particularly in the flu-season.

Commercial strategy

Developmental requirements and timelines required for marketing, and securing use authorisation of CVX 20733, CVX 20755, and CVX 20788

Summary of commercial strategy for CVX 20733, CVX 20755, and CVX 20788
The extreme COVID Delta crisis in India in 2021 presented a timely opportunity for COVIRIX to fast track the commercialization of our repurposed drugs. The Indian regulatory authority issued new guidelines in 2021 which provide for rapid approval of drugs including repurposed drugs. Accordingly, we believe the first market to commercialize our antivirals is likely to be on the Indian subcontinent.

Our CEO Professor Kumud Dhiltal is currently based in New Delhi, India and also works as a frontline clinician dealing with COVID patients. He has strong relationships which will enable COVIRIX to gain support from Indian regulatory authority and local drug manufacturers, including seeking appropriate regulatory waivers for animal toxicology study based on established use data (see item 5 of next slide) and support for human clinical trials.

COVIRIX is partnering with one of the largest European drug manufacturers to contract produce our drugs as well as providing the appropriate inhalation devices. This company has unique expertise in inhaled drug delivery devices. The European company has substantial FDA approved production capacity of GMP standard and can produce Active Pharmaceutical Ingredients for supply to the global markets.

COVIRIX has an in-house team of inhaled drug delivery experts who are also uniquely experienced in aerosol antiviral drug development, dose formulation, and drug synthesis. The combination of in-house expertise supported by the significant European drug manufacturer will enable COVIRIX to have more than sufficient technical and manufacturing resources to effect our commercial strategy.

COVIRIX CANDIDATE DRUGS

A search of the CAS database (the worlds largest chemical database) on the 22nd of July 2021 indicates that the approved drugs claimed in our antivirals application have expired and the originators can therefore no longer have any claims to the chemical entities/drugs. A summary of the search results are set out below.

OTHER VIRUSES - Potential Additional Targets

The following were selected as examples of viruses that currently cause significant disease in humans and are related to viruses that pose potential risks for originating future epidemics/pandemics. We anticipate our therapeutics will have activity against these based on the mode of action:

Market Opportunities

Commercial strategy

OTHER VIRUSES - Potential Additional Targets

The following were selected as examples of viruses that currently cause significant disease in humans and are related to viruses that pose potential risks for originating future epidemics/pandemics. We anticipate our therapeutics will have activity against these based on the mode of action:

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