Ziccum today launches a news portal – Ziccum Updates – on its website to share company news updates in a short, accessible format for investors, partners and followers..
The news posts will typically cover internal updates and initiatives, as well as scientific updates and reports from industry events, to complement the company’s regular press releases and give more insight into the company activities and progress.
Visit the portal here: www.ziccum.com
Watch Ziccum CEO Ann Gidner in an exclusive new video interview with Eucaps analyst Jonathan Furelid. It provides insights and analysis of Ziccum’s new Evaluation Agreement, its third in six months, plus the company’s Q3 highlights.
Ziccum AB (publ) (‘Ziccum’) has signed a Material Transfer and Evaluation Agreement for a Vaccine Evaluation project with one of the most important technology-focused Biomanufacturing corporations in the US. The project is funded and will focus on evaluating the potential for new dry, thermostable forms of an advanced viral vaccine, using Ziccum’s unique formulation and drying technology LaminarPace. Ziccum has signed three agreements for funded partner studies since May 2023, and these add up to combined revenues of 10 MSEK.
The new agreement is the third major partner contract for funded Feasibility studies that Ziccum has signed in recent months. It significantly broadens the company’s strategic and biotherapeutic position. Strategically, it is the first agreement for the company with a Biomanufacturing corporation- a vital industry segment in vaccine manufacturing.
The project aims to evaluate Ziccum’s unique formulation and drying technology, LaminarPace, for treatment of an advanced viral vaccine material. The material belongs to one of the three high-potential vaccine platforms that Ziccum targets and has worked on in-house. If successful, the project will represent a significant step forward in demonstrating LaminarPace’s potential across markets and modalities.
Ziccum’s new partner company is one of the US’ largest technology-focused Biomanufacturing corporations. It has a portfolio of domestic and international partners providing advanced, end-to-end manufacturing solutions for comprehensive pandemic preparedness. The company has capabilities in vaccines, gene therapy, cell therapy, nucleic acids and more.
This third agreement for funded studies signed with a major, international corporation in recent months confirms the significant acceleration Ziccum has made in its business development and strategic and scientific progress over the last year since the appointment of new CEO Ann Gidner in 2022. In total, the three agreements for partner studies give Ziccum a combined revenue of 10 milion SEK for the initial steps agreed upon.
Ziccum Chairman Fredrik Sjövall: “This is a great step forward for us strategically, covering a new vaccine platform and an important new key market segment. We can’t wait to get the project started!”
CEO Ann Gidner: “We are honored that our technology will be evaluated by such an important partner for technological and medical advancement. As someone with extensive experience in Biomanufacturing industry right from its inception, I’m aware of the competitive advantage the future use of LaminarPace could generate for this type of partner. This Agreement reflects that innovation in vaccine formulation, and new stable and thermostable formulations, could play a fantastic role in making the world better prepared for pandemics.”
Significant events during the quarter
Other events during the quarter
Other events after the third quarter
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
| Financial summary | Q3 | Q3 | Jan-Sep | Jan-Sep | Full year |
| KSEK | 2023 | 2022 | 2023 | 2022 | 2022 |
| Net revenue | 2,329 | 0 | 4,743 | 0 | 0 |
| Operating result | -3,899 | -6,674 | -13,857 | -20,888 | -28,955 |
| Result | -3,882 | -6,599 | -13,720 | -20,767 | -28,788 |
| Balance sheet total | 21,764 | 42,582 | 21,764 | 42,582 | 33,285 |
| Cash flow | -4,793 | -7,054 | -16,161 | 17,320 | 10,678 |
| Cash and cash equivalents | 9,790 | 29,593 | 9,790 | 29,593 | 22,951 |
| Equity ratio % | 73 | 87 | 73 | 87 | 88 |
| Per share data (SEK) | |||||
| Number of shares | 13,806,142 | 13,806,142 | 13,806,142 | 13,806,142 | 13,806,142 |
| Result per share before and after dilution* | -0.28 | -0.48 | -0.99 | -1.50 | -2.09 |
| Cash flow per share | -0.35 | -0.52 | -0.95 | 1.27 | 0.78 |
| Equity per share | 1.51 | 2.69 | 1.51 | 2.69 | 2.12 |
Link to report:
https://ziccum.com/investors/financial-reports/
Ziccum AB (publ) has 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.
The external confirmation and extended data set of preserved mRNA activity after LaminarPace treatment was obtained with cell-based in-vitro assays by the CRO. The study was performed to validate the internal mRNA activity data previously reported on March 20th. The new data give a clear and distinctive confirmation of the ability of Ziccum’s LaminarPace technology to transform delicate mRNA/LNP solution into stable, bioactive dry powder with excellent in-vitro characteristics.
mRNA is one of the three target vaccine platforms Ziccum focuses on, and its in-house mRNA project is of central strategic importance, considering the market need and growth. In October 2022, Ziccum reported proof of successful nebulization and drying of a vaccine/LNP model substance. In March 2023, Ziccum reported the same positive confirmations regarding encapsulation and particle properties for actual mRNA/LNP trials, plus confirmed mRNA activity after LaminarPace drying and reconstitution to liquid. These findings have since then been repeatedly confirmed in continued internal studies. The new CRO activity read-outs are obtained in a different mRNA model – and having the same clear activity preservation in a second mRNA model makes the validation stronger.
Ziccum has recently signed two major agreements for Evaluation Studies on mRNA/LNP treatment with LaminarPace – the first in May with a leading Biopharmaceutical corporation, the second in July with a multinational Pharmaceutical corporation. These collaborations also will include in-vitro activity readouts.
CEO Ann Gidner: “Investment and innovation in RNA and mRNA therapies continue to grow and the industry efforts are very impressive. Solutions for stability and delivery that can enable new vaccine and drug projects could broadly expand the possibilities for this booming therapeutic platform. These distinct mRNA activity results for Ziccum constitute excellent and important confirmation. The next step is the in-vivo data, to see this confirmed in animal models. This work is starting now”.
Ziccum has appointed senior international biotech engineering manager Xavier Turon as its new Chief Operating Officer. Turon will lead the team developing LaminarPace, Ziccum’s unique mass transfer drying system, and is bringing extensive academic and industrial experience. His appointment follows the recruitment of a new CFO as Ziccum delivers on its strategy of growing its management capabilities.
As Ziccum is progressing with a successful new strategy and business model, rewarded by recent agreements with leading Pharma and Biotech partners, the company is introducing a new position in its management team. A Chief Operating Officer has been recruited to manage the Operations team and to lead the important LaPaSim project for 3D-modelling of the LaminarPace technology. This strengthening of the Ziccum team will contribute to the successful development of the core technology, as well as help delivering results in the partnered projects.
Xavier Turon brings excellent industrial and academic expertise to the company. His track record in Chemical engineering and Life Science management is a valuable fit for Ziccum; Turon has deep expertise in biological drying processes, including freeze-drying and spray drying, as well as specific experience working in proteins and peptides. Most recently as Industrial Biotech Manager at Lipotec, Lubrizol Life Science in Spain, he led a team designing, developing and scaling up GMP-quality manufacturing plants for pilot as well as commercial scale for bioactive ingredients.
In addition, Turon has significant academic expertise. From 2008 – 2016 he was Assistant Professor at the Chemical Institute of Sarrià (IQS) in Barcelona, leading the Bioprocesses unit in developing and scaling up bioprocesses from benchtop to pilot. His international experience includes three years as Associate Researcher at the State University of North Carolina in the US, as well as background as a Doctoral Researcher in Chemical Engineering at Polytechnique Montreal, Canada’s leading engineering university.
Xavier Turon: “I am pleased and excited to join Ziccum. LaminarPace is a genuinely unique technology which will contribute to developing better biotherapeutics. It clearly fills an industrial need – I look forward to contributing to its ongoing technological and industrial development while joining the excellent, growing team at Ziccum. The stage is set for a major breakthrough in biopharmaceutical drying".
Ziccum CEO Ann Gidner: “Xavier is a very valuable recruitment for Ziccum, and we welcome him warmly. His extensive knowledge in chemical engineering science will help ensure the best possible advancements in the LaPaSim project and further strengthen our dialogues with teams and prospects. The role will be pivotal in driving successful LaminarPace development forward, to enable new, user-friendly formulations of RNA and other vital biotherapeutics”.
In part two of her Analyst interview CEO Ann Gidner offers a deep dive into the second of the company’s recent milestone Feasibility agreements plus an analysis of mRNA, why it is generating such historic levels of investment, and how Ziccum’s unique drying technology LaminarPace could be a key enabler in unlocking its potential.
With two paid Evaluation agreements signed with world-leading mRNA partners, after having proven the LaminarPace technology for mRNA/LNP treatment, Q2 2023 was the most successful in Ziccum’s history. CEO Ann Gidner describes the company’s achievements and road ahead in the first of two CEO interviews.
Ziccum AB is to present at the BioFuture 2023 conference in New York City, October 4 – 6 2023, a key industry event attracting top-tier investors to evaluate innovators in biopharmaceuticals.
Ziccum CEO Ann Gidner will present Ziccum’s unique drying technology for biopharmaceuticals, LaminarPace, and its market potential at BioFuture 2023. Uniquely, LaminarPace enables new delivery and greatly improved stability for biopharmaceuticals, potentially making new treatments available for patients world-wide. Most importantly, the enormous potential of the mRNA/LNP therapy and vaccine platform could be unlocked if delivery and stability challenges were solved. Ziccum presented excellent data in mRNA/LNP trials during spring 2023, followed by two prestigious industrial feasibility agreements being signed.
Driven by public & private initiatives, BioFuture has emerged as a hub for innovation in the life sciences and digital health space. LifeSciNY is allocating 500 MUSD in investment to build the Life Science arena.
Ziccum has been represented at a series of high-profile industry events throughout the year – including the Global mRNA Therapeutic Summit in Boston, Mass. and the invitation-only Longwood Healthcare Leaders Spring Conference. In June / July, Ziccum reported signing two major new Evaluation Agreements for Feasibility Studies for mRNA/LNP projects with major Pharmaceutical/Biotech corporations leading the mRNA-field.
Ann Gidner: “it is exciting to participate at BioFuture in New York. We are proud to be presenting the Ziccum core concept, successful data and the very significant mRNA market outlook to US investors, taking a next step in our international outreach”.
