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Inhalation Sciences Sweden AB (publ) releases Annual Report 2021

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(Stockholm, Sverige, 11 April 2022) Inhalation Sciences AB announces that its Annual Report 2021 is now available on the company’s website. To read the whole Report (in Swedish), please visit: http://inhalation.se/investors/finansiella-rapporter/

Significant events during the reporting period

  • On February 10, ISAB announced that it has acquired an expanded internationally registered trademark for PreciseInhale® in strategic markets such as the United States, India and China.
  • On August 16, the company announced that the important patent for aerosol generation via PreciseInhale had been extended in the US until August 2034.
  • On October 12, ISAB announced its renewed collaboration with Karolinska Institutet regarding the validation of the new module XposeALI® MP (Micro Perfusion) in the Mars dust study.
  • On September 29, ISAB announced its collaboration with Redeye for company analysis and expanded collaboration regarding IR activities.
  • On November 25, ISAB announced that it has registered a trademark for PreciseInhale®, DissolvIt® and XposeALI® in the United States.

Significant events after the reporting period

  • On January 18, the company announced that it had sent an application for a study (white paper) to the FDA. This applies to DissolvIt® and to getting approved as a ‘Gold Standard’ recommended dissolution method for inhalation studies.

CEO STATEMENT

The financial year 2021 continued to be another year with challenges surrounding COVID-19 and its effects on our operations. Despite the challenges and restrictions however we navigated the year efficiently and are proud to be able to summarize 2021 as a positive and successful year for Inhalation Sciences AB.

We achieved several major milestones in 2021, all of which lay a good foundation for our continued expansion:

• Sales in the fourth quarter reached a peak of just over SEK 7,300,000 in sales orders received. We carried out some of these during the same period and will continue to work on invoicing our order backlog in the coming months.

• The clinical study of PreciseInhale was successfully completed with demonstrated efficacy regarding 1) precise and accurate dosing (regional targeting) and 2) greater efficacy compared to a standard inhaler in a clinical setting. The study was completed on time and in budget and we are now preparing to chart the best possible way forward for the company in the clinical environment.

• An application to the US Food and Drug Administration (FDA) was submitted in January 2022 with the goal of obtaining an FDA recommendation for our dissolution module DissolvIt® to be used in inhalation research and development. The application is the result of several months’ dialogue with the FDA, and the market potential for DissolvIt®, following a possible FDA recommendation, is enormous, given that we are establishing the method as a new "Gold Standard method for Dissolution". This may well guide customers and research institutes in inhalation research and development towards the company.

In addition to achieving these important strategic goals, we have also continued to successfully reach new and existing customers in a focussed, goal-oriented way. The value of our sales pipeline and quotation requests has increased by 50% compared with the same period the previous year. We plan to further strengthen our commercial organization in early 2022.

Finally, the company has initiated an upgrade of our quality management system with the goal of becoming fully compatible with ISO 13485. This is a quality system that can be used by industry in both pre-clinical and clinical settings as demand for our products and services increases over time, driven by both regulatory standards and the expectations of our customers.

I look forward confidently to an exciting 2022 where we can continue to work based on our strategic plan, developing Inhalation Sciences AB, together with our customers, and increasing added value for both our partners and owners.

Huddinge April 11, 2022

Manoush Masarrat

VD

To read full report (in Swedish) go HERE.

For more information about Inhalation Sciences, please contact:

Manoush Masarrat, CEO

E-mail: Manoush.masarrat@inhalation.se

Mobile: +46 (0)73 628 9153

About Inhalation Sciences Sweden AB (publ)

Inhalation Sciences Sweden AB (publ) develops and commercializes world-leading instruments and services for research into inhalation. The company’s patented lab instruments PreciseInhale® and DissolvIt® enable researchers in the pharma industry to make drug pipeline decisions at an early stage, saving time and resources for R&D departments, and enables researchers in academic institutions to define how aerosols and small particles impact our lungs, and so our health, when being inhaled.

The information above was provided by Inhalation Sciences Sweden AB (publ) through the above contact person, for publication on 11 April 2022.

Tags:

Inhalation Drug Evaluation lung research aerosols aerosol generation inhaled drug assessment

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