ISR - Immune System Regulation Holding AB (publ.) 2[nd] half of 2021, including year-end report is now published on the website: www.israb.se

“2021 has been a very eventful year, where ISR has been moving at high speed in the development of our full-spike dry powder COVID vaccine for nasal administration, which has also led ISR as a company to quickly develop and adapt to requirements to ensure reaching our set goals. In 2022, we expect to drive a fast, efficient and successful clinical process for future regulatory marketing approval for ISR52 as primary vaccination in COVID, in parallel with continued development of other projects and intensified partner discussions for commercialization” Ola Winqvist, CEO of ISR

Significant events during the half-year and year-end report 2021

2021-02-16 - ISR's Immunolide strengthens the effect of Checkpoint Inhibitor in animal model of colon cancer.
2021-03-02 - ISR starts clinical study for HIV patients who are resistant to antiretroviral drugs.
2021-03-12 - ISR is provided with SEK 22.2 million through the exercise of warrants of series TO1
2021-03-17 - ISR's inhaled vaccine protects well against Covid in animal model
2021-03-29 - First patient included from Munich for ISR's HIV study
2021-03-31 - ISR signs agreement with Iconovo for the development of inhaled Covid-19 vaccine
2021-06-18 - ISR Immune System Regulation AB initiates collaboration with Inhalation Research Services as a partner in the toxicology program for ISR52 inhalation vaccine for COVID-19
2021-07-12 - ISR deepens cooperation with Iconovo for development of nasal covid-19 vaccine
2021-07-18 - ISR signs agreement with Singapore Resources Development PTE. Ltd. Regarding investment in subsidiaries for the development of inhaled Covid-19 vaccine
2021-08-06 - ISR AB enters MoU agreement to start vaccine study in Bangladesh
2021-08-08 - ISR enters a letter of intent with UniMed UniHealth Pharmaceuticals Ltd in Bangladesh
2021-09-14 - ISR signs contract to start vaccine study in Bangladesh
2021-09-29 - ISR vaccine AB has been formed and received the first investment
2021-10-06 - ISR signs contract with Northway Biotech for production of vaccine
2021-10-21 - ISR strengthens its organization by appointing a Chief Commercial Officer
2021-11-02 - ISR includes a letter of intent with Bumivac Ventures SDN BHD in Malaysia
2021-11-11 - ISR Vaccine AB signs cooperation agreement with Icosagen for vaccine pipeline
2021-11.24 - Warrants of series T02 are exercised to approximately 97.3 percent and ISR Holding AB will receive approximately SEK 62.4 million
2021-12-02 - ISR Vaccine AB signs agreement with Oncovir Inc for manufacture of adjuvant for ISR SARS-CoV-2 vaccine
2021-12-17 - ISR ensures large-scale vaccine production via agreement with Revitalife

Significant events after the end of the financial statements

2022-01-21 No signs of toxicological reactions for ISR´s vaccine candidate against SARS-CoV-2 - An important step for further development
2022-01-26 ISR´'s vaccine gives antibody response to the Omicron variant of SARS-CoV-2
2022-02-21 ISR’s application submitted to Bangladesh Medical Research Council (BMRC) to lead the approval process to conduct a Phase I/II study with ISR52 nasal powder vaccine against SARS CoV-2

Financial Information

Dear Shareholders,

2021 has been a very eventful year, both for ISR as a company and for the outside world in general.

By the latter, I mean the Covid-19 pandemic, which since the Spring of 2020 has kept the world in its grip and leaves us with a lot of uncertainty about the future.

For ISR, Covid-19 has posed challenges for the pace of development of our projects in general within immunology, where we are already conducting front line development.

Among such challenges, I am thinking mainly of the HIV study, where participating clinics in the clinical trial have slowed down the pace in patient recruitment - but where we now expect the study to be fully recruited sometime in early 2022.

The outbreak of Covid-19, in the spring of 2020, has also produced new possibilities to ISR - especially regarding a huge medical need for the development of nasal inhalation vaccine against Covid-19 - which is easily accessible to everyone, does not require a cold chain and enables the immune response to start at the nasal entry point io the virus.

For ISR, this has, in parallel with the rapid implementation of the preclinical phase toxicological tests, together with securing large-scale production for the clinical trials, meant both a strong start-up in the business and a need for ISR as a company to develop in order to secure ISR´ s compliance with various regulatory requirements in the operation of the business. and the requirements of the future market.

The possibilities have expanded considerably during the year 2021, as a consequence of the vaccines that are available so far, not proving to offer complete protection against new variants such as "Delta" and "Omicron".

As the spike protein we use includes the virus' entire exposed protein chain - we have a solid basis for our vaccine to provide effective protection against both current and future variants.

As I write this, ISR has recently reported that in recent preclinical tests we have shown that our intranasal dry powder vaccine activates the production of antibodies that are effective against the Omicron-variant and completed extensive toxicological studies that show that vaccines are safe and can go on to clinical examination.

During the year, ISR also demonstrated the ability to execute through the signing of most business-critical agreements, in order to secure access to important components for large-scale production of dry powder vaccine, device for nasal administration of vaccine, and "fill & seal" of the final product, which will be used both in the clinical trials for use in future commercial markets.

The above has also led to ISR as a company developing rapidly, where we through a number of recruitments of key functions and the conclusion of strategic cooperation agreements ensure that ISR as a company meets the requirements set, to ensure delivery against set goals - with ultimate consequence to maximize value and returns for our shareholders.

2022 has now begun with intensive work at a high pace to start a clinical phase I/II study for our nasal Covid-19 vaccine, in order to drive the remaining clinical studies towards market approval and subsequent market launches.

With these concluding words, I would like to thank all shareholders for the support and trust you give us and for the ambassadorship you perform for us, with the ambition that together we will make 2022 a very successful year for ISR.

Ola Winqvist, CEO, ISR Immune System Regulation Holding AB (publ.)

For more information, see the year-end report in Swedish:

At 1 pm (CET) February 23, analysts, investors and the media are invited to participate in a presentation where CEO Ola Winqvist, CFO Jonas Winqvist and CCO and Sven Rohmann present the report. After the presentation, a Q&A will be held. Questions can also be sent in advance to info@israb.com no later than 11.30 am.