Industry Updates Volume 19

SARS-CoV-2:  From Vaccine Scarcity to Vaccine Demand Destruction and Vaccine Glut

• The World Health Organization (WHO) shows no signs of removing the world-wide emergency Pandemic designation for SARS-CoV-2, but no new Variants of Concern/Interest announced
  • Ongoing reports of further Omicron variant derivatives continue to appear around-the-world
• However, world-wide vaccine demand has cratered, going from a mid-2021 7-day moving average peak of 43+ Million doses/day to 12 Million dose/day presently → 25% of peak demand
  • More significant demand destruction in developed world →  E.g., U.S. went from 3.5 Million peak demand doses/day in April 2021 to 300K doses/day currently → 10% of peak demand
  • Current daily U.S. rates are now down to < 100K doses/day
• Vaccine manufacturers have therefore curtailed vaccine production → E.g., Serum Institute of India (SII) stopped production in December 2021, with 200+ Million doses stockpiled
  • World-wide SARS-CoV-2 manufacturing capacity is estimated at 9 Billion doses in 2022
  • 2023 demand is estimated to be 2.2 - 4.4 Billion doses
• Factors contributing to this demand destruction include: 1) Lowest global SARS-CoV-2 infection caseloads, hospitalizations and deaths since March 2020; 2) Lower SARS-CoV-2 measurement levels in most countries, except China, which is mass measuring under its Zero COVID-19 Policy; 3) Vaccination levels peaking in many developed countries; and 4) Concerns over waning immunity and safety issues with existing vaccines, further amplifying vaccine hesitancy
• Despite 11.5+ Billion doses having been administered world-wide to date, Bloomberg estimates that at current vaccination rates, it will still take 11 months to achieve having 75% of the world population with at least one vaccination
  • 12 Million doses/day X 11 months = almost 4 Billion more shots needed to hit this target
  • Mostly to low-income countries, where 15% of people have only received one vaccine shot
  • Consistent with Refana estimates that 2-3.5 Billion people still do not have access to vaccines

However, the Quest for Next Generation Vaccines Continues

• To get to more effective vaccines, current providers - and new participants like Refana - continue to develop their next generation vaccines.   Examples:
  • Moderna testing a bivalent mRNA vaccine (Wuhan and Beta variants)
  • RefanaVax-MV a trivalent WIV vaccine (Delta, Omicron variants + 1 more variant, as required)
  • Moderna, Pfizer/BioNtech working on Omicron mRNA vaccines
  • Moderna, Novavax working on combined SARS-CoV-2/Flu vaccines
• Other attempts at nasal spray SARS-CoV-2 vaccines, more universal pan-coronavirus-based vaccines are ongoing → Longer-term development exercises

And WIV-based Vaccines Continue to Make Progress

• Valneva’s WIV vaccine was approved by UK’s MHRA in mid-April
• Valneva secured additional U.S. $40 Million in non-dilutive debt financing for WIV development
  • Increases a ‘counter- cyclical’ bet to finance Valneva’s WIV vaccine - initially made in March 2020 - by OrbiMed/ Deerfield, two highly-regarded U.S. early-stage healthcare investors

Zero Covid Policies in China Leading to Massive Supply Chain Disruptions, Potential Global Economic Impacts

• China continues to execute its Zero COVID-19 policy, including major city lockdowns in Shanghai (26+ Million people), and massive SARs-CoV-2 testing in Beijing (21+ Million people)
• Since March, full or partial lockdowns in 20+ Chinese cities represents ~200 Million residents (13.6% of China’s population) and $3.6 Trillion (22%) of China’s economy
• As reported last month, despite 3.3+ Billion vaccine doses administered in China (88+% fully- vaccinated rate), China still has > 130 Million residents over 60 years of age who are not vaccinated at all, or are under-vaccinated, and highly exposed to SARS-CoV-2 infections
• Given this Zero COVID-19 Policy, the World Bank estimates China’s economic growth will decline from 8+% in 2021 to 5% in 2022, below China’s estimate of 5.5%.  Goldman Sachs predicts 4.5%
• World-wide impacts of this economic slowdown have not yet been fully-felt globally; with many countries so dependent on China for finished goods, this could lead to further global supply chain shocks and and an amplification of current inflationary trends experienced world-wide
  • With predictions of a global recession becoming more and more prevalent.

Refana Update - Further Vaccine Developments

• As mentioned last month, Refana’s vaccine is called RefanaVax-MV → MV = MultiValent
• The Proof-of-Concept of the RefanaVax-MV monovalent (Delta strain) vaccine showed no safety/side-effect issues; all animals challenged with a 10X ‘fatal’ dose of Delta virus survived the challenge with no infection or disease symptoms
  • Including an animal that showed no substantial neutralizing antibodies after the prime/boost regimen, suggesting protection was enabled by generating t-cell responses to the virus
• The Illinois Institute of Technologies Research Institute’s (IITRI) research paper publishing these results has been accepted by the American Society of Virology (ASV) Conference in July 2022
• Refana continues to work with a number of parties on funding proposals to NIAID, the National Institute of Allergy and Infectious Diseases, and to other parties for further stages of funding, which would take this Project further, to full trials and if successful, ultimate approval
• Refana believes that the RefanaVax-MV WIV vaccine solution - coupled with Refana’s modular manufacturing system design - offers a strong solution for assisting with the current SARS-CoV-2 Pandemic and also to help the world prepare for the next Pandemic to come

Refana Update - Other Developments

• As Refana’s vaccine developments continue, the company has begun to explore other medical solutions - building back to Refana’s founding investment thesis - to explore the application of Artificial Intelligence (A.I.) for focused medical applications
• Further details will be provided when appropriate

Refana Communication - Investor Update

• Given the currently reduced intensity levels of the SARS-CoV-2 Pandemic, Refana will change the distribution of this update from a monthly distribution to a quarterly distribution
• With four Quarterly Investor Updates, Refana’s next update will appear on 30th June, 2022.

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