ZICCUM AB (publ) Interim report Q3 2023

Significant events during the quarter

• On July 17th the company announced it has signed an evaluation agreement with a major global Pharmaceutical Corporation. The agreement is to perform a funded feasibility study aiming to develop thermostable dry powder formulations in the partner mRNA/LNP projects, with a planned extension for stability testing and an option to license the LaminarPace technology.
• On September 5th the company announced that Xavier Turon has been appointed as Chief Operating Officer and he will assume his position on October 9th, 2023.

Other events during the quarter

• On July 26-28, Ziccum participated at the 3rd Annual mRNA Summit in Boston. CEO Ann Gidner gave a presentation to an audience of senior pharmaceutical industry decision makers, scientists, and key opinion leaders. Ziccum also presented a Scientific poster (’A Novel Unit Operation Successfully Drying mRNA/LNP by Mass Transfer’) - the first scientific poster Ziccum has delivered at a major event.
• On September 6, Ziccum participated in the conference New Updates in Drug Formulation and Bioavailability in Copenhagen.

Other events after the third quarter

• On October 23, Ziccum announced that it had received data from external contract research (CRO) partner Truly Labs, confirming high activity levels in mRNA/LNP materials dried by LaminarPace, after continued internal confirmations. The in-vitro data validate the ability of Ziccum’s LaminarPace technology to transform delicate mRNA/LNP solution into stable, bioactive dry powder with excellent in-vitro characteristics.
  

CEO statement
Intensive data generation with world-leading Partners

After kicking this quarter off with signing the second of two milestone agreements with world-leading mRNA players, now generating significant revenue for Ziccum, we have had an exciting time both externally, participating in leading industry forums, and internally, building the Ziccum team further with strong competence and generating further important data for the mRNA/LNP platform.

Joining forces with world-leading Biotech and Big Pharma
Whilst our Biotech Corporation mRNA Feasibility collaboration is already running, we were delighted to take the Big Pharma Evaluation study negotiation to completion and signatures. The scope is more encompassing, with both a paid Feasibility study for the partner mRNA/LNP material, and a planned extension for stability testing and an option for the Big Pharma to license the LaminarPace technology. It is a great recognition, for Ziccum to be handpicked from the crowded lineup of potential partners for this international leader in vaccine development.
 
Apart from the very concrete and large business value if we can take these two collaborations forward, if the studies prove such good results for the mRNA/LNP entities at hand with LaminarPace as we expect, there is immediate value generated for Ziccum by the partnership interaction. It is a delight to exchange ideas and review progress with these highly skilled industry experts. And obviously it is a great milestone for Ziccum to be revenue generating, thanks to our successful execution of the new business model. This gives a most appreciated further extension of the financial runway ahead.
 
Furthermore, we are taking great strides when it comes to strengthening our academic collaborations, and we are planning additional analytical capabilities in-house to ensure that we are on top of trial readouts and particle assessments.
 
LaminarPace data generation at a new pace
The Ziccum team has made an excellent effort in increasing the productivity in trial execution, and we have been able to take both partnered studies and internal projects forward very efficiently. The initial findings regarding mRNA/LNP treatment with LaminarPace are continuously confirmed, which is extremely rewarding. To further validate the findings on mRNA activity after LaminarPace drying, we have engaged a good analytical services partner to make testing in several models, and the trials in cell-based assays have given distinct validation of the ability of LaminarPace to transform delicate mRNA/LNP solution into stable, bioactive dry powder with excellent in-vitro characteristics. We are moving to the next step of in-vivo studies now, looking forward to key read-outs.
 
Targeting the new era in pharmaceutical industry and getting significant recognition
After applying the technology successfully for the most delicate targets - mRNA in LNP formulation - during spring, it was a pleasure to take part in the Global mRNA Summit in Boston in July, a large gathering of the leading experts in this booming field. One can only be amazed at seeing how the entire, global pharmaceutical industry is racing to take RNA projects forward to market. Also, it was strongly emphasized how mRNA could become a cornerstone treatment for all kinds of indications – if only RNA can be made ‘user-friendly’, with solutions to delivery and stability limitations. This is exactly what Ziccum is enabling, with LaminarPace formulation and drying – so there is indeed a tremendous market need to meet here for our technology, in this highest value part of biopharmaceuticals.
 
There are several new dialogues initiated, existing talks taken forward and it is truly rewarding to see the recognition we are building up in industry.
 
Building the Ziccum professional level further
We were happy to welcome a new colleague during this quarter – Deepak Anand who is bringing a great scientific postdoc profile to the team. I am very pleased to build a diverse team with an impressively broad experience base, bringing valuable perspectives and ensuring a good outlook to stay abreast of industry developments. This was further emphasized as we were delighted to announce the appointment of a broadly experienced engineering manager, Xavier Turon from Barcelona, as our new Chief Operating Officer to join in October.
 
In our Quality Assurance we are taking structure and documentation initiatives forward, ensuring that there is an efficient path for fulfilling pharmaceutical standards, both short term in our running partnerships and long term to get LaminarPace industrialized. We are also assessing potential partners for equipment development and supply going forward.
 
We have a hectic time ahead, with a keen focus on executing on our partnership studies as well as taking the business dialogues and technology optimization forward. Let me thank the team for excellent efforts, as well as collaboration partners and owners for continued support and creative dialogues.
 
Lund, October 25, 2023
Ann Gidner, CEO

July- September in brief

• Total revenues: SEK 2,329 (0) thousand.
• Result for the quarter: SEK -3,882 (-6,674) thousand.
• Earnings per share: SEK -0.28 (-0.48).
• Cash flow for the quarter: SEK -4.793 (-7,064) thousand.
• Cash at the end of the reporting period: SEK 9,790 (29,593) thousand.

Link to report:
https://ziccum.com/investors/financial-reports/