Emergex Shareholder Update - January 2022

Dear Shareholders

Emergex is a technology pioneer in the field of T cell vaccines and 2021 has represented an outstanding year of progress with our transition to being a clinical-stage company. Thank you for your continued support of the efforts to advance our expertise, science, and technology towards improving lives worldwide.

Heading into 2021, we established the following goals:

  • Gain regulatory approval for the initiation of a Phase I clinical trial of our Dengue vaccine candidate
  • Seek regulatory approval to initiate a Phase I clinical trial of our next generation Coronavirus vaccine candidate
  • Strengthen our senior management team and Board of Directors
  • Undertake an additional funding round

In this update, we wish to highlight the significant accomplishments achieved in support of our 2021 goals. We are proud to report that Emergex continues to attract key talent for diverse roles across the company and has ended the year in a strong cash position. We are especially proud of the fact that Emergex has achieved first-in-human testing of an experimental T cell vaccine for the prevention of Dengue fever. This represents our first vaccine construct, derived from our understanding of the expressed viral peptide code (the viral ‘ligandome’) combined with our gold nanoparticle delivery system, to enter clinical testing. The Phase I clinical trial took place in Switzerland and initial data appear promising. As required, an independent group of experts, the Data and Safety Monitoring Board (“DSMB”), reviewed the interim safety results and approved commencement of the second arm of the trial for our Coronavirus vaccine construct. The results and opinions from the DSMB were shared with the Swiss regulatory authorities. The Coronavirus arm of the trial has commenced this month, with the first patient having already received their first vaccine dose. At the same time, initial immunogenicity findings from the Dengue arm of the trial have been reported, with further immunogenicity data and the interim clinical study report projected for the first weeks of January 2022. We look forward to updating you on these clinical developments.


Steps were taken to ensure that Emergex remains well positioned to continue our preclinical and clinical stage development efforts for our vaccine candidates into 2022.

  1. Vickers Ventures was granted 516,304 warrants at £7.25 per share in June Vickers has now exercised those warrants in this latest funding round, resulting in cash of £3,743,204.
  2. Emergex is in the process of closing the Series A3 round at £10 per share. This round has raised just above £10m and will enable Emergex to continue with its development programmes according to our corporate strategy until Q4 The pre-money valuation on fully diluted shares at £10 per share is £221m and a post-money valuation of £233m.
  3. Emergex has received all of the £1M agreed between the Company and Bio- Manguinhos/Fiocruz for the development of a COVID-19


 Emergex has taken steps to optimize the manufacture of our vaccines, as well as to assess microneedle delivery device technologies.

  1. Our R&D team have continued to make and test our vaccine technology for feasibility studies and basic research. These studies have included looking at alternative linker chemistry, and the kinetics of peptide uptake and release in mouse model
  2. Much of the recent efforts of our R&D team have focused on supporting technology transfer to our manufacturing team. Manufacturing process development has yielded methodology to improve the vaccine scale up process, which we anticipate will benefit our Phase II/III clinical
  3. Our analytical capabilities have been enhanced with the purchase of key
  4. We continued assessment of microneedle patch delivery systems. Application and stability testing of our Coronavirus vaccine coated onto microneedle patch/devices is ongoing with two external partners, to inform a rational selection process for a patch/device to be included in future clinical studies. A workstream has been initiated to map the anticipated regulatory pathway for a vaccine-coated microneedle patch/device.


 Emergex has initiated and completed enrolment of its first clinical trial for our Dengue vaccine construct in Switzerland. This represents a significant milestone for Emergex, and we continue to build upon this momentum within our clinical programme.

  1. Emergex’s clinical development strategy continues to prioritize our novel Coronavirus vaccine candidate so that our technology might be part of an appropriate response to the unprecedented and ongoing Coronavirus pandemic.
  2. The initial clinical study arm (Dengue vaccine) of the Phase I clinical trial in Switzerland has completed enrolment and is undertaking the planned patient follow up. A blinded interim immunology report was delivered just before the end of last year, and we have begun assessment of the information as additional data continue to be We are encouraged by the trial results thus far.
  3. The Data and Safety Monitoring Board (“DSMB”) reviewed the interim safety results from the Dengue arm of the Swiss trial and approved commencement of the second arm of the trial for our Coronavirus vaccine This development has been communicated to the Swiss regulatory authorities. The second study arm (COVID-19 vaccine assessment) started in January 2022.
  4. Continuing our innovative approach in terms of Clinical Development, and in line with the ongoing Phase I trial in Switzerland, Emergex is moving forward with an adaptive Phase I/II and Phase II/III clinical trial model for both Emergex vaccine candidates (Dengue and Coronavirus). We are planning for these trials to be undertaken in endemic countries (Singapore, Philippines, and Brazil [to be confirmed]) for Dengue, and in the case of Coronavirus, countries with significant Coronavirus activity during the global pandemic. Initiation of these Phase I/II trials represents one of our major goals for 2022.
  5. A leading global clinical research organization (CRO) has been identified and is now contracted for performing these next clinical trials.
  6. Emergex is currently also progressing with the Clinical Development strategy for its vaccines in the USA. Discussions have progressed with the United States Department of Veteran Affairs (VA) to execute a Cooperative Research and Development Agreement (CRADA) for conducting a Phase I/II clinical trial in the US for one or more of our vaccine candidates within a military veteran beneficiary population. We anticipate that the VA will start with our Coronavirus vaccine candidate.
  7. An Investigational New Drug (IND) application package has been developed to request approval to initiate a clinical Phase I/II clinical trial in the US. The submission of this IND application to the FDA is anticipated to occur early in


 Vaccine manufacturing currently consists of both outsourced and in-house efforts to meet clinical trial supply and future vaccine supply needs. Although the Coronavirus pandemic has impacted timelines for some of our in-house manufacturing efforts, we were nevertheless able to meet all our clinical trial supply needs thus far.

  1. The second batch of both Dengue and Coronavirus vaccines has been successfully manufactured and will provide sufficient clinical material for trials scheduled over the next 18
  2. cGMP manufacture of our Influenza vaccine candidate is ongoing in readiness for clinical trials which represent one of our major goals for
  3. Scale up manufacturing programmes for cGMP grade starting materials (peptides and ligands) have been initiated in readiness for later stage clinical trials and commercial
  4. It has been a challenging period for our in-house Stericube manufacturing facility with the Coronavirus pandemic impacting timelines. In particular, critical overseas contractors were unable to visit the site due to travel restrictions and we have experienced long lead times on numerous items due to supply chain Nevertheless, the project is moving forward, and good progress has been made.
  5. The Stericube Class C unit, and large sized equipment within it (such as laminar air flow systems), has now been fully validated. This is a significant milestone, as it now means the physical facility itself is fit for purpose and should meet regulatory
  6. A strong manufacturing team continues to be built with 3 new members having joined since our last update including Simon McEwen, our new Quality Director. Simon formerly held a senior position at the VMCI (Vaccine Manufacturing and Innovation Centre) in Harwell, UK, where he was responsible for implementing a quality system
  7. We are preparing the facility for inspection by the Medicines and Healthcare products Regulatory Agency (MHRA) for award of a cGMP license (timelines to be confirmed at the start of 2022).


 Emergex has recently seen an increased interest in its vaccines and associated media opportunities. Emergex has also initiated several strategic business activities around vaccine delivery technologies as well as clinical development collaborations.

  1. Q4 2021 has seen a number of company press releases and considerable media engagement around our Coronavirus vaccine Emergex has been the subject of interest in a range of global publications, both ‘trade’ and ‘mainstream’ media ranging from Nature to The Guardian and the BBC in the UK. There are several important benefits to this level of exposure, one of which is that Emergex Vaccines now features on the majority of new vaccine development trackers, as well as building awareness of our development programme with both investors, potential partners, as well as the general public.
  2. The December Emergex Board of Directors (BOD) meeting approved initiation of due diligence on Latch Medical (manufacturer of hollow and coated microneedle devices) with a view to establish a potential development partnership in early 2022. This work has been
  3. Our subsidiary, Emergex USA Corporation, is operating efficiently and providing important immunoproteomics support for the Company. In January 2022, there will be a relocation of the laboratory space at the leased facility in Doylestown PA, where our two scientists are located, owing to the Bio incubator
  4. A Vice President of Governmental Affairs in the US has been hired. An extremely important consideration for the formation of a US subsidiary was to enable a US presence that would facilitate US grants/governmental This individual is highly experienced in US Governmental Affairs and will also be able to provide on the ground support in the US to help the existing staff and for other corporate administration responsibilities.
  5. The Emergex BOD has agreed to create a US subsidiary Board of Directors, which will operate formally starting in
  6. Fiocruz in Brazil has proposed its sponsorship of Phase II clinical trials in Brazil for both the Dengue and Coronavirus vaccine candidates. Further details will follow in the next

Our progress in 2021 has enabled Emergex to start 2022 with strong momentum. We are committed to continue accelerating the clinical development of our vaccine candidates, ensuring the appropriate resources and capabilities are in place, providing significant value to our shareholders, and promoting a highly motivating environment for high performance-oriented individuals to develop their careers. We appreciate your continued support and look forward to a new era for Emergex in 2022 and beyond.


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