IR Archives - Page 4 of 32

The exercise period for warrants of series TO5 in Ziccum commences today

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, HONG KONG, JAPAN, CANADA, NEW ZEALAND, SWITZERLAND, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, RUSSIA, BELARUS OR IN ANY OTHER JURISDICTION IN WHICH THE RELEASE, DISTRIBUTION OR PUBLICATION OF THIS PRESS RELEASE WOULD BE UNLAWFUL, REQUIRE REGISTRATION OR ANY OTHER MEASURES THAN THOSE REQUIRED BY SWEDISH LAW. SEE ALSO THE SECTION ”IMPORTANT INFORMATION” BELOW.

Today, 2 September 2024, the exercise period for Ziccum AB (publ)’s (”Ziccum” or the ”Company”) warrants of series TO5 (the ”Warrants”), issued in connection with the rights issue of units that ended in February 2024, begins. One (1) unit consisted of one (1) share and one (1) free of charge Warrant. According to the terms and conditions for the Warrants, each Warrant entitles the holder to subscribe for one (1) new share in the Company at an exercise price corresponding to the lowest of i) SEK 8.00 or ii) the subscription price of the most recently resolved share issue, in the event that the Company has resolves on a new issue of shares with deviation from the shareholders’ pre-emption rights between 1 February 2024 and 31 August 2024. In accordance with previous communication, the Company resolved on a new issue of shares with deviation from the shareholders’ pre-emption rights to Global Corporate Finance (“GCF”) on 25 June 2024. The subscription price in that new issue of shares amounted to approximately SEK 4.91 per share, and thus the exercise price for the Warrants has been set at SEK 4.91. The exercise period for the Warrants runs up to and including 13 September 2024.

Summarized terms for the Warrants

Exchange ratio: For each one (1) Warrant, the holder may subscribe for one (1) new share in the Company.
Exercise period: 2 September 2024 – 13 September 2024.
Exercise price: 4.91 SEK per share.
Issue volume: 943,745 Warrants. Upon full exercise, 943,745 new shares will be issued, and the Company will receive approximately SEK 4.6 million in issue proceeds before issue costs.
Trading in Warrants: The Warrants are admitted to trading on Nasdaq First North Growth Market under the ticker ”ZICC TO5” with ISIN code SE0021512308.
Last day of trading in the Warrants: 11 September 2024.

Please note that the Warrants that are not exercised for subscription of shares on the 13 September 2024 at the latest, or are sold no later than 11 September 2024, will expire without value. For the Warrants not to lose their value, holders must actively exercise their Warrants for subscription of new shares or sell their Warrants within the above stated time. Please also note that some banks/nominees may close their application earlier than 13 September 2024, and for this reason, holders who have their holdings of Warrants nominee-registered are encouraged to contact their bank or nominee at an early stage.

Complete terms and conditions for the Warrants are available on the Company’s website (www.ziccum.com).

How the Warrants are exercised

Nominee-registered Warrants
Subscription and payment of new shares, by exercise of Warrants, shall be made to the account-holding bank/nominee with which the Warrants are registered. The subscription and payment shall be made in accordance with instructions from each such bank or nominee.

Directly registered Warrants
No payment instructions will be sent out. Subscription shall be made by simultaneous cash payment in accordance with the instructions on the subscription form. The Warrants will then be replaced with interim shares pending registration with the Swedish Companies Registration Office.

A subscription form with instructions for payment is available on the Company’s website (www.ziccum.com) and on the website of the issuing agent Vator Securities AB (www.vatorsecurities.se).

Share capital and dilution
Upon exercise of all Warrants, the registered share capital will increase by approximately SEK 157,290.83, from approximately SEK 2,655,815.83 to approximately SEK 2,813,106.67, and the number of shares will increase by 943,745 shares, from 15,934,895 shares to 16,878,640 shares. The dilution upon exercise of all Warrants amounts to approximately 5.59 percent of the number of shares and votes in the Company.

Advisors
Vator Securities AB is acting as issuing agent and Fredersen Advokatbyrå AB is acting as legal advisor to Ziccum in connection with the exercise of the Warrants.

Important information
The information in this press release does not contain or constitute an offer to acquire, subscribe for or otherwise trade in shares, warrants or other securities in Ziccum. This press release is not a prospectus within the meaning of the Prospectus Regulation (EU) 2017/1129 (the ”Prospectus Regulation”) and this press release does not identify or purport to identify risks (direct or indirect) that may be associated with an investment in shares, warrants or other securities in Ziccum. No prospectus will be prepared by the Company and published on the Company’s website in connection with the exercise of Warrants.

The publication, announcement or distribution of this press release may, in certain jurisdictions, be subject to legal restrictions and persons in the jurisdictions where this press release has been published or distributed should inform themselves about and observe such legal restrictions. The recipient of this press release is responsible for using this press release and the information contained herein in accordance with the applicable rules in each jurisdiction. This press release does not constitute an offer or an invitation to acquire or subscribe for any securities in Ziccum in any jurisdiction, neither from Ziccum nor from anyone else.

This press release does not constitute an offer or invitation to purchase or subscribe for securities in the United States. The securities referred to herein may not be sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended (the ”Securities Act”), and may not be offered or sold in the United States absent registration or an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There is no intention to register any securities referred to herein in the United States or to make a public offering of such securities in the United States. The information contained in this press release may not be announced, published, copied, reproduced or distributed, directly or indirectly, in whole or in part, in or into the United States, Australia, Hong Kong, Japan, Canada, New Zealand, Switzerland, Singapore, South Africa, South Korea, Russia, Belarus or any other jurisdiction where such announcement, publication or distribution of this information would be contrary to applicable law or where such action is subject to legal restrictions or would require additional registration or other measures than those required by Swedish law. Actions in contravention of this guidance may constitute a breach of applicable securities laws.

The Company considers that it carries out protection-worthy activities under the Swedish Screening of Foreign Direct Investments Act (2023:560) (the “FDI Act”) (Sw. lag (2023:560) om granskning av utländska direktinvesteringar). According to the FDI Act, the Company must inform presumptive investors that the Company’s activities may fall under the regulation and that the investment may be subject to mandatory filing. If an investment is subject to mandatory filing, it must prior to its completion, be filed with the Inspectorate of Strategic Products (the ISP). Each warrant holder should consult an independent legal adviser on the possible application of the Swedish FDI Act in relation to the warrant exercise for the individual warrant holder.

Forward-Looking Statements
This press release contains forward-looking statements that reflect the Company’s intentions, beliefs or expectations regarding the Company’s future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that do not relate to historical facts and can be identified by the fact that they contain expressions such as ”believes”, ”expects”, ”anticipates”, ”intends”, ”estimates”, ”will”, ”may”, ”assumes”, ”should”, ”could” and, in each case, negatives thereof, or similar expressions. The forward-looking statements in this press release are based on various assumptions, many of which are based on additional assumptions. Although the Company believes that the assumptions reflected in these forward-looking statements are reasonable, there can be no assurance that they will materialise or that they are accurate. Because these assumptions are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcomes may differ materially from those in the forward-looking statements for a variety of reasons. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied by the forward-looking statements in this press release. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are correct and any reader of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements expressed or implied herein speak only as of the date of this press release and are subject to change. Neither the Company nor anyone else undertakes to review, update, confirm or publicly announce any revision to any forward-looking statement to reflect events that occur or circumstances that arise in relation to the content of this press release, unless required by law or applicable listing rules.

About Ziccum

Ziccum is developing LaminarPaceTM, a unique drying method for biopharmaceuticals and vaccines based on mass transfer, not heat transfer. The technology is offered by licensing to vaccine and biologics developers and manufacturers in the global pharmaceutical industry. By reducing drying stress to the active ingredient, LaminarPaceTM uniquely enables particle-engineered, thermostable dry powder biopharmaceuticals which can be easily handled and transported and are highly suitable for novel administration routes. The technology has been successfully applied to mRNA, peptides, proteins, antibodies, lipids and enzymes as well as excipients and adjuvants, and is well suited for industrial application. Ziccum is listed on the Nasdaq First North Growth Market.

The exercise period for warrants of series TO5 in Ziccum commences today

Ziccum TO5 VP-konto, Subscription Form

Board's Statement, Chapter 14, Section 32 of the Swedish Companies Act

Auditor's Statement, Chapter 14, Section 32 of the Swedish Companies Act

Ziccum AB (publ) Interim report Q2 2024

INTERIM REPORT Q2, 1 JANUARY – 30 JUNE 2024

Significant events during Q2 2024

Ziccum strengthens and streamlines business and finance functions
On April 3, the company announced that it is reorganizing its administrative functions, due to the increased amount of business dialogues and to perform financial reporting in a more streamlined fashion. Two new roles of Business & Project Manager and a business-oriented, junior Financial Manager are introduced while the CFO role is eliminated.

Ziccum CEO to present at first annual event for Biopharma/Biotech Disruptors hosted by major US bank in New York City
On April 10, the company announced that on Tuesday May 14th, in New York City, Ziccum CEO Ann Gidner will present at the first event on high-value biotech and biopharma disruptor technologies to be hosted by CapitalOne, one of the US’ largest bank corporations. She will present as part of an expert panel regarding mRNA and gene therapeutics.

Ziccum contracts RFR Solutions for GMP manufacturing in next phase of technology scale-out
On April 26, the company announced that in addition to its existing network of high expertise suppliers and consultants, Ziccum has signed a long-term agreement with the GMP equipment specialist RFR Solutions, for the next phase in the industrialization and scale-out of the LaminarPaceTM equipment.

Ziccum AB strengthens patent portfolio with three solid data PCT applications according to expanded IP strategy
On April 30, the company announced that they have filed three PCT with ample and significant data covering years of equipment development and refinement, process parameter knowledge gained, plus key biopharmaceutical formulation expertise established. These various perspectives provide multi-layered protection to the company’s unique drying technology LaminarPaceTM.

Ziccum partners with Dagens Industri for Investor Relations program
On May 28, the company announced that they partner with Dagens Industri, the largest Nordic business paper, to improve shareholders’ access to news updates and raise broader awareness of its continuous scientific and commercial progress.

Exercise of employee stock options of series LTI 2021:1 at Ziccum AB (publ)
On 27 April 2021, the Annual General Meeting of Ziccum AB (publ) ("Ziccum" or the "Company") resolved on a directed issue of no more than 46,000 employee stock options of series LTI 2021:1 (the "Stock Options") to certain employees and consultants in the Company. On June 3, Ziccum announced that 14,819 warrants of series 2021/2024 (the "Warrants"), in relation to LTI 2021:1, have been exercised for subscription of 23,709 new shares in the Company.

Ziccum reports on developments in the portfolio of industry partner projects
On June 11, the company announced that Ziccum is continuously engaged in business discussions with potential industrial partners. The status of Ziccum’s project portfolio is presented quarterly in the company interim reports. There are currently further updates to report.

Ziccum signs Evaluation agreement with ReCode Therapeutics for LaminarPace mRNA study
On June 19, Ziccum AB signed an Evaluation Agreement with ReCode Therapeutics, Inc. (ReCode), a US clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, for evaluation of LaminarPace enabling dry powder forms of ReCode’s proprietary therapeutic modalities.

Ziccum calls for a second investment tranche in accordance with its financing agreement with GCF
On June 25, the board of directors of Ziccum AB (publ) (“Ziccum” or the “Company”) called for a second investment tranche in accordance with the previously communicated financing agreement between the Company and Global Corporate Finance (“GCF”), and in connection therewith resolved to carry out a directed share issue.

Significant events after Q2 2024

Ziccum investigates significant increase in mRNA activity achieved with LaminarPace
On August 16, Ziccum AB (publ) announced important findings on an increase in mRNA drug activity after LaminarPace treatment and the investigations of the potential mechanisms behind this effect, including the development of a new, unique analytical method to generate further proof for this effect.

CEO statement

Remarkable new technology advancement and keen international interest

After fully confirming our mRNA capabilities in first quarter 2024, we are happy to build such keen interest for our technology, across the international industry. Now seeing the ability to increase the mRNA activity for certain formulations, applying LaminarPace at optimal conditions, is amazing. The potential value of LaminarPace to achieve better and completely new biopharmaceuticals has reached new levels. This could eliminate interest for any tentative competing solutions.

Proving LaminarPace for mRNA/LNP – even increasing protein expression

While the LaminarPace technology has been successfully applied for all kinds of fragile, demanding biopharmaceuticals – proteins, peptides, antibodies and more – the current focus of Ziccum is to address the booming field of mRNA in lipid nanoparticle formulation (mRNA/LNP). This is no small feat. The amount of data generated in a short timeframe 2023/24 is rewarding, especially as every data set is positive; in a completely new field one could expect various outcomes. The first animal study performed gave very clear, good preservation of mRNA activity for LaminarPace material.

In addition to partnered trials during spring, Ziccum spent important efforts generating further mRNA data, optimizing performance both in pilot scale trials and in the 3D-modelling performed in parallel. In this work, we have been intrigued to see not only well preserved but also increased mRNA activity, in terms of protein expression in live cells. This triggered more investigation, and we are delighted to announce both the confirmation of this effect, and the continued work to understand the mechanisms behind it. We are thrilled to investigate this further.

Unique value creation for industry leading partners

We now have repeated external validations from reputable industry players. Also, we have reached a stage where the world’s largest pharmaceutical corporations are approaching Ziccum to learn more – a unique situation for a company our size. While it is very rewarding to see the industry interest, a lot of effort of course remains to get widespread industry recognition. Ziccum is not spending the marketing budgets of large corporations. But with hard work and using a significant industry network, we are already reaching out to key stakeholders and generating keen interest on a global scale.

While we have very good results in our partnered studies, with validation by world leading corporations, the current Big Pharma II partner has chosen not to proceed at the present time, having many competing priorities. This is well in line with the Ziccum strategy, where a pipeline of many collaborations will be needed considering the conservative approach in pharmaceutical industry – and as we have the great benefit of a technology platform. We are delighted to have signed with ReCode Therapeutics, especially as this is an mRNA pioneer, also working at the pharmaceutical forefront and open to new technology. We keep adding advanced dialogues to our portfolio. Obviously, having an even stronger potential value proposition, increasing mRNA activity in new therapies or vaccines, industry interest can be fuelled further.

Progressing with more convincing data

The Masterplan project work is intense. In addition to the studies in live cells, resulting in the new findings of higher mRNA activity, we are planning for further animal data. The inhalation studies with Copenhagen University are reconciled into a new format, to ensure timely delivery from our partner. We are excited to see the outcome. Old drying methods like lyophilization can rarely be applied to biologics at all, and could never give fine, tailor-made particles applicable by inhalation. For LNP formulations, inhalation has been considered impossible by industry – until LaminarPace was applied.

In addition to the animal studies proving mRNA activity, we are also progressing towards next level studies, to assess the immune response in animals.

LaminarPace development continues

The development of the LaminarPace rig continues with a keen focus having secured further partnerships with leading expertise. A main topic is the continuous product outtake, which will be key to high capacity. This work is strongly accelerated, using our 3D model to assess configurations quickly and easily.

During the quarter we secured significant intellectual property (IP) protection. We have progressed our patent applications to international PCT stage and added a high number of patent claims for all three fields, thanks to the high pace of internal trials. This is creating a strong, multilayered protection for Ziccum. Based on the investigations of LaminarPace giving higher mRNA activity, we may have the basis for further patent protection.

Developing Ziccum and planning ahead

To ensure the company’s financials for its ambitious growth plans while balancing low expenditures, to serve shareholders’ best interest, the company board of directors and management are assessing options for the company’s capital needs ahead. Without increasing costs, we have been able to recruit two new, talented colleagues to the international Ziccum team, strengthening our analytical, financing and business capabilities: most happy to welcome Christo Vassilev and Ilkim Atmaca.

We have very interesting results ahead. Let me thank everyone involved for such valuable efforts, give a warm welcome to new board members and my appreciation to partners, owners and investors for continued support. Looking forward to next steps together!

Lund, August 30th, 2024
Ann Gidner

Financial summary

	Apr-Jun		Apr-Jun	Jan-Jun	Jan-Jun	Jan-Dec
kSEK	2024		2023	2024	2023	2023
Operating income		367	1,776	3,615	2,414	6,318
Operating result		-7618	-5,060	-11,641	-9,995	-21,560
Result		-7,647	-4,965	-11,604	-9,837	-21,412
Balance sheet total		15,791	24,635	15,791	24,635	14,972
Cash flow		-4,967	-4,440	1,098	-8,368	-19,956
Cash and cash equivalents		4,092	14,583	4,092	14,583	2,994
Equity ratio %		52	80	52	80	57
Per share data (SEK)
Number of shares		15,372,258	13,806,142	15,372,258	13,806,142	13,806,142
Result per share before and after dilution*		-0.50	-0.36	-0.75	-0.71	-1.55
Cash flow per share		-0.34	-0.32	0.08	-0.61	-1.45
Equity per share		0.53	1.43	0.53	1.43	0.62

* Dilution effect is not calculated when the result is negative

About Ziccum

Ziccum AB Q2 Report 2024

Ziccum investigates significant increase in mRNA activity achieved with LaminarPace

Ziccum AB (publ) announces important findings on an increase in mRNA drug activity after LaminarPace treatment and the investigations of the potential mechanisms behind this effect, including the development of a new, unique analytical method to generate further proof for this effect.

Ann Gidner, CEO: “This potential effect after LaminarPace processing is of great significance and we have made rather extensive testing to verify it. With this potential for increasing mRNA activity, Ziccum may progress into a new value proposition for LaminarPace for certain formulations. This is in addition to the already proven benefits unlocking new treatments on the booming RNA platform, as well as for biopharmaceuticals in general. We are thrilled to investigate this further”.

Fabrice Rose, Scientific Director: “We found it important to determine not only the protein expression increase, but also the potential reasons behind it. Drug delivery mechanisms are always complex, but now we have a clear hypothesis, and we have developed a new method to investigate this further. I am very proud of the team efforts and the results this far”.

In Ziccum’s internal Master Plan work, several different formulation options for mRNA have been tested for optimization during spring 2024. The lipid nanoparticle (LNP) formulation field is currently subject to intense development, as the industry is rapidly advancing new RNA treatments. Ziccum has performed a successful development plan, assessing improved LNP compositions to work well with LaminarPace processing.

During this work, a special effect has been discovered for certain lipid compositions, where the drug product mRNA activity is not only preserved, but significantly increased after LaminarPace treatment. The effect is studied by measuring protein expression in live cells treated with mRNA.

At the present time the following has been established:

A very significant increase in mRNA protein expression occurs after LaminarPace processing for several different lipid formulations.
The protein expression is multiplied in the best cases.
The increase effect only occurs for certain variants of lipid nanoparticle compositions.
An LNP structural phenomenon involved has been identified.
This special LNP structure is well described in scientific literature.
Ziccum has identified a potential mechanism on cellular level for the resulting protein expression increase.

The industrial value of increased mRNA activity as a consequence of LaminarPace processing can potentially be significant for several reasons.

Cost: If this increase in effectiveness can be translated into lower mRNA drug and vaccine doses, the consumption of very expensive mRNA substances can be reduced.
Dose barrier: The current LNP formulations which have enabled vaccines and therapies based on mRNA have a limitation regarding mRNA content. With increased activity through LaminarPace processing, it may be possible to break these barriers and create more efficient new treatments.

The understanding of the mechanism underlying this increase is of importance for Ziccum to better understand the potential value to the pharmaceutical industry.

Ziccum therefore has developed a specific, proprietary analytical method to study nanoparticle (mRNA/LNP) trafficking from the cellular uptake to the mRNA release and to the translation to the protein. This analytical method has now been established and tested.

The next step is to apply the new analytical tool for continued investigation of the increase mechanism, with the aim of creating a clear explanation for the effect taking place. This work will be pursued with high priority in the coming months.

There will also be a need for stability testing further on. It should be noted that the current effect is noted directly after treatment, while the long-term effects remain to be studied.

The current findings have been established in cell-based testing, not yet in animal studies.

About Ziccum

Ziccum investigates significant increase in mRNA activity achieved with LaminarPace

Analyst interview with Ziccum’s CEO on new project and expanding business dialogues

In a Swedish video interview, Ziccum’s CEO Ann Gidner answers questions from analyst Jonathan Furelid on the topic of business dialogues and agreements.

Apart from elaborating on the significance of the recently concluded Feasibility Study Agreement with ReCode Therapeutics, a leader in the booming mRNA field, Ann Gidner also concludes on the successful completion of the first stage of the Big Pharma II Feasibility Study. Furthermore, Ziccum’s CEO underscores the increasing industry-wide interest generated by Ziccum’s technology, LaminarPaceTM, as evidenced by the growing number of leading industry players reaching out to Ziccum.

Please watch the full interview (in Swedish) here: https://youtu.be/-dnOT8oFLHs

About Ziccum

Analyst interview with Ziccum's CEO on new project and expanding business dialogues

VD-Intervju på svenska: Ziccums senaste avtal och den fortsatta affärsutvecklingen

Vår VD Ann Gidner svarar på frågor om de uppdateringar bolaget delat gällande den växande portföljen av affärsdialoger den 11 juni, samt ett projektavtal som nu signerats, den 19 juni.

Q: Ni kommunicerade den 19 juni att Ziccum tecknat ett nytt utvärderingsavtal med ReCode Therapeutics för en LaminarPace-studie med mRNA. Hur ser du på betydelsen av detta avtal?

A: Vi är verkligen nöjda att ha signerat ännu ett avtal, nu med ReCode Therapeutics, ett Biotech-bolag i Kalifornien med ambitiösa satsningar på nya mRNA-behandlingar. Vi kommer att undersöka möjligheterna att skapa bättre och på sikt kanske helt nya former av ReCodes mRNA-terapier. ReCode är en extra intressant spelare, eftersom de har en spjutspets inom mRNA-fältet med sin unika LNP-formulering som når specifika organ – och de arbetar fokuserat med inhalation. Så det är verkligen roligt att samarbeta, och att vi har fått lov att publicera deras namn.

Q: Vilka specifika fördelar erbjuder LaminarPace för ReCodes mRNA/LNP-formuleringar?

A: Med LaminarPace kan man skapa stabila former av mRNA/LNP – och med stora vinster i form av kraftigt förbättrad hantering och projektekonomi, öppnar det för att helt nya behandlingar kan bli möjliga. Dessutom ger LaminarPace en unik möjlighet att skräddarsy partikelegenskaper. Det går inte att åstadkomma med någon annan känd metod; med till exempel gammaldags frystorkning kan man i vissa fall lyckas få ut en kaka av torkat material, men man kan inte styra processen och får ingen väldefinierad produkt – definitivt inte med skräddarsydda pulveregenskaper för till exempel inhalation.

Ziccum har lyckats generera mRNA i inhalerbar form, med helt rätt egenskaper. Det är mycket eftertraktat i industrin. Vi inväntar djurstudier hos vår akademiska partner för att jämföra inhalation av vår produkt med vanlig injektion. Rent generellt vill både läkare och patienter undvika injektioner, och många bolag lägger stora ansträngningar på inhalationsprodukter. Vi har en mycket lovande lösning under utveckling.

Q: Ni släppte nyligen även en uppdatering gällande era pågående partnersamarbeten och dialoger. Kan du berätta mer om de bredare affärsdiskussioner som Ziccum är engagerade i?

A: Vi har blivit kontaktade av flera stora industrispelare, så kallade Big Pharma-koncerner, som har stort intresse för de möjligheter som vår teknologi öppnar upp. Vi har hållit presentationer av LaminarPace under våren till stora utvecklingsteam i dessa bolag. En lovande möjlighet är med Big Pharma III, som har föreslagit en försöksstudie med ett proteinbaserat projekt. Det ger lite mer bredd vad gäller läkemedelstyper: genom att bredda vår projektportfölj minskar vi risken i utvecklingen, och ökar vår affärspotential.

Q: Vad är nästa steg för samarbetet med Big Pharma II?

A: Studien med Big Pharma II har gett bra resultat, vad gäller såväl s.k. enkapsulering och partikelegenskaper, som resultatet i form av mRNA-aktivitet i cell-studier. Den första fasen är avslutad, och partnern bedömer för närvarande om de ska gå vidare med den andra fasen av projektet. Den här typen av spelare har många olika möjligheter att utvärdera för mRNA generellt.

Q: Kan du berätta mer om framstegen med Biotech Corp II och Biotech IV?

A: Projektet med Biotech Corp II gav verkligen utmärkta resultat, men partnern har ännu inte beslutat om ett nästa steg. Vi har intresse i flera delar av organisationen där. För Biotech IV är vi framme – det är ju ReCode Therapeutics där vi nu har skrivit avtal och kan namnge vår partner!

Q: Vad gör samarbetet med Biotech Corp V inom området för vaccin med adjuvans lovande?

A: Vaccin med adjuvans har en extra ingrediens vilken ökar immunsvaret för vaccinet, en elegant lösning. Vår expertis inom det här området ligger väl i linje med Biotech Corp V:s intressen för bättre vaccinhantering och tänkbara, stora konkurrensfördelar tack vare LaminarPace. Inhalation kan vara aktuellt här. Om vi går vidare med en studie för deras produkter i utveckling skulle det stärka vår portfölj och ge ytterligare bekräftelse för LaminarPace inom det området.

Q: Hur ser du på Ziccums framtida samarbeten och den roll som LaminarPace kommer att spela för läkemedelsindustrin?

A: Det är spännande att ta våra studier och vår utveckling framåt. Industrin inser i allt högre grad behovet av praktiska lösningar för att kunna gå från fantastiska läkemedelsmöjligheter, till fungerande patientbehandlingar till rimliga kostnader. Den här frågan är uppe på varje konferens i branschen numera. Våra pågående och potentiella samarbeten återspeglar detta stora, konkreta behov hos de spelare som utvecklar mRNA och andra biologiska läkemedel. Det är fantastiskt för oss att intresset är så starkt, att vi kan delta i utvecklingen och bidra till att helt nya behandlingar kan bli verklighet.

Om Ziccum

Ziccum utvecklar LaminarPace, en unik metod för torkning av biologiska läkemedel och vacciner i rumstemperatur. Metoden bygger på massöverföring istället för värmeöverföring. Tekniken licensieras ut till utvecklare och tillverkare av vaccin och biologiska läkemedel inom den globala läkemedelsindustrin. Genom att minska den stress som den aktiva substansen utsätts för under torkningen erbjuder LaminarPace en unik möjlighet att ta fram termostabila biologiska läkemedel med partikel-teknologi i en torr pulverberedning. Dessa är enkla att hantera och transportera och lämpar sig utmärkt för nya administreringssätt. Tekniken har framgångsrikt tillämpats på mRNA, peptider, proteiner, antikroppar, lipider och enzymer, samt på hjälpämnen och adjuvanter, och lämpar sig väl för industriell tillämpning. Ziccum är noterat på Nasdaq First North Growth Market.

VD-Intervju på svenska: Ziccums senaste avtal och den fortsatta affärsutvecklingen

Ziccum calls for a second investment tranche in accordance with its financing agreement with GCF

The board of directors of Ziccum AB (publ) (“Ziccum” or the “Company”) has called for a second investment tranche in accordance with the previously communicated financing agreement between the Company and Global Corporate Finance (“GCF”), and in connection therewith resolved to carry out a directed share issue.

On 22 January 2024, the Company announced in a press release, inter alia, that it had entered into a long-term financing agreement with GCF (the “Financing Agreement”), pursuant to which Ziccum has the unilateral right to call for investments from GCF in separate tranches totaling the equivalent of USD 2.7 million over a period of 30 months, thereby securing rapid access to capital injections to cover the Company’s budgeted costs until 2025.

The board of directors of Ziccum has now called for a second investment tranche under the Financing Agreement and has today resolved, based on the authorization granted by the Annual General Meeting on 29 May 2024, to carry out a directed share issue to GCF of a total of 538,928 shares for proceeds of approximately SEK 2,650,253 (the “Directed Share Issue”). The subscription price in the Directed Share Issue has been set at SEK 4.91764 per share in accordance with the terms and conditions set out in the Financing Agreement and as further described in the Company’s press release dated 22 January 2024.

Prior to the Directed Share Issue, the Company’s board of directors has made an overall assessment and carefully considered the possibility of raising capital through a new share issue with pre-emption rights for the Company’s existing shareholders. However, the board of directors considers that there are reasons to deviate from the shareholders’ pre-emption rights given that the Directed Share Issue can be carried out in a more time-efficient manner, at a lower cost and with less complexity than a rights issue. In addition, the board of directors considers the speed and predictability of the procedure with the Directed Share Issue, in light of the Financing Agreement, as a significant advantage, as it is deemed to facilitate the Company to act in the current market and to safeguard the Company’s interests, in line with the Company’s strategy and overall objectives. Taking into account the above, the board of directors considers, after an overall assessment, that the Directed Share Issue is the most appropriate and favorable option for Ziccum and all its shareholders.

As the subscription price in the Directed Share Issue has been determined in accordance with the terms and conditions set out in the Financing Agreement, it is the board of directors’ assessment that the subscription price has been secured on market terms.

Through the Directed Share Issue, the number of outstanding shares and votes in Ziccum increases by 538,928 from a total of 15,372,258 to a total of 15,911,186 shares and votes. The share capital increases by SEK 89,821.333333 from SEK 2,562,043.000003 to SEK 2,651,864.333336. Further, the Directed Share Issue entails a dilution of approximately 3.39 per cent of the number of shares and votes in the Company following the completion of the Directed Share Issue. Taking into account also the exercise of the series 2021/2024 warrants relating to LTI 2021:1, which was communicated by press release on 3 June 2024 and has yet to be registered with the Swedish Companies Registration Office, the number of outstanding shares and votes in Ziccum will increase by a further 23,709 to a total of 15,934,895 shares and votes. The share capital will increase by a further SEK 3,951.50 to SEK 2,655,815.833336 and the dilution effect will be a further 0.15 percentage points, totaling approximately 3.54 per cent.

Important information
The publication, announcement or distribution of this press release may, in certain jurisdictions, be subject to legal restrictions and persons in the jurisdictions where this press release has been published or distributed should inform themselves about and observe such legal restrictions. The recipient of this press release is responsible for using this press release and the information contained herein in accordance with the applicable rules in each jurisdiction. This press release does not constitute an offer or an invitation to acquire or subscribe for any securities in Ziccum in any jurisdiction, neither from Ziccum nor from anyone else.

This press release is not a prospectus within the meaning of Regulation (EU) 2017/1129 (the ”Prospectus Regulation”) and has not been approved by any regulatory authority in any jurisdiction. No prospectus will be prepared by the Company and published on the Company’s website in connection with the Directed Share Issue.

In the United Kingdom, this document and other materials relating to the securities referred to herein are only being distributed and directed to, and any investment or investment activity to which this document relates is available only to, and will be engaged in only with, ”qualified investors” (as defined in section 86(7) of the Financial Services and Markets Act 2000) who are (i) persons who have professional experience in matters relating to investments and who fall within the definition of ”investment professionals” in Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the ”Order”); or (ii) ”high net worth entities” as referred to in Article 49(2)(a) to (d) of the Order (all such persons together being referred to as ”relevant persons”). An investment or investment activity to which this communication relates is available in the United Kingdom only to relevant persons and will be engaged in only with relevant persons. Persons who are not relevant persons should not take any action based on this announcement and should not act or rely on it.

The Company considers that it carries out activities worthy of protection under the Swedish Screening of Foreign Direct Investments Act (2023:560) (the “FDI Act”). In accordance with the FDI Act, the Company must inform prospective investors that the Company’s activities may fall within the scope of the regulation and that the investment may be notifiable. In the event that an investment is notifiable, it must be notified to the Inspectorate for Strategic Products (ISP) prior to it being carried out.

Forward-looking statements
This press release contains forward-looking statements that reflect the Company’s intentions, beliefs or expectations regarding the Company’s future results of operations, financial condition, liquidity, performance, prospects, anticipated growth, strategies and opportunities and the markets in which the Company operates. Forward-looking statements are statements that do not relate to historical facts and can be identified by the fact that they contain expressions such as ”believes”, ”expects”, ”anticipates”, ”intends”, ”estimates”, ”will”, ”may”, ”assumes”, ”should”, ”could” and, in each case, negatives thereof, or similar expressions. The forward-looking statements in this press release are based on various assumptions, many of which are based on additional assumptions. Although the Company believes that the assumptions reflected in these forward-looking statements are reasonable, there can be no assurance that they will materialise or that they are accurate. Because these assumptions are based on assumptions or estimates and are subject to risks and uncertainties, the actual results or outcomes may differ materially from those in the forward-looking statements for a variety of reasons. Such risks, uncertainties, contingencies and other important factors could cause actual events to differ materially from the expectations expressed or implied by the forward-looking statements in this press release. The Company does not guarantee that the assumptions underlying the forward-looking statements in this press release are correct and any reader of this press release should not place undue reliance on the forward-looking statements in this press release. The information, opinions and forward-looking statements expressed or implied herein speak only as of the date of this press release and are subject to change. Neither the Company nor anyone else undertakes to review, update, confirm or publicly announce any revision to any forward-looking statement to reflect events that occur or circumstances that arise in relation to the content of this press release, unless required by law or First North’s Rulebook for Issuers.

About Ziccum

Ziccum calls for a second investment tranche in accordance with its financing agreement with GCF

Ziccum tecknar utvärderingsavtal med ReCode Therapeutics för LaminarPace-studie med mRNA

Såsom publicerat 19 juni 2024, har Ziccum AB (publ) tecknat ett avtal med ReCode Therapeutics Inc. (ReCode) beträffande utvärdering av LaminarPace-teknologin. ReCode är ett amerikanskt läkemedelsbolag som utvecklar nästa generations mRNA- och genterapier, baserat på speciella formuleringar för att nå specifika organ. Avtalet innebär ett samarbete för att utvärdera om LaminarPace kan möjliggöra mer robusta och effektiva former av ReCodes läkemedelsmolekyler.

Ziccum AB tecknade utvärderingsavtalet med ReCode den 19 juni 2024. Studien kommer att fokusera på att utvärdera Ziccums formulerings- och torkningsteknik, LaminarPace, för att skapa pulverformuleringar av ReCodes material: terapeutiskt mRNA i specifik lipidnanopartikel-formulering, så kallad mRNA/LNP, på ReCodes egenutvecklade SORT-plattform.

LaminarPace-resultaten kommer att utvärderas genom analyser av den resulterande mRNA/LNP-produkten, både vad gäller fysikalisk-kemiska egenskaper och läkemedelsaktivitet i levande celler.

VD Ann Gidner: “Vi är mycket glada att kunna föra vår dialog med ReCode framåt till ett formellt samarbete. Potentialen att möjliggöra nya och optimala tillämpningar av ReCodes målsökande mRNA-teknologi, och deras position som ledare inom det intensivt växande mRNA-området, är verkligen tilltalande. Vi är mycket glada att kunna lägga till en så stark partner och ser fram emot att komma igång med detta projekt.”

Om Ziccum

Ziccum tecknar utvärderingsavtal med ReCode Therapeutics för LaminarPace-studie med mRNA

Ziccum signs Evaluation agreement with ReCode Therapeutics for LaminarPace mRNA study

Ziccum AB (publ) has signed an Evaluation Agreement with ReCode Therapeutics, Inc. (ReCode), a US clinical-stage genetic medicines company using tissue-specific delivery to power the next wave of mRNA and gene correction therapeutics, for evaluation of LaminarPace enabling dry powder forms of ReCode’s proprietary therapeutic modalities.

Ziccum AB signed an Evaluation agreement with ReCode on June 19th, 2024. The study will focus on evaluating Ziccum’s formulation and drying technology LaminarPace to enable dry powder forms of ReCode material: therapeutic messenger-RNA in specific liquid lipid nanoparticle formulation, mRNA/LNP, on ReCode’s proprietary SORT platform.

The LaminarPace performance will be evaluated by analytical assessment of the resulting mRNA/LNP dry product, with technical parameters as well as mRNA activity in cell transfection.

CEO Ann Gidner: “We are delighted to take our dialogue with ReCode forward to a formal collaboration. The potential of enabling new and optimal applications of the targeting mRNA technology of ReCode, and their position as a leader in the intensely growing mRNA field, is indeed enticing. We are most happy to add such a strong partner and look forward to getting this work started.”

About Ziccum

Ziccum signs Evaluation agreement with ReCode Therapeutics for LaminarPace mRNA study

Ziccum reports on developments in the portfolio of industry partner projects

Ziccum is continuously engaged in business discussions with potential industrial partners. The status of Ziccum’s project portfolio is presented quarterly in the company interim reports. There are currently further updates to report.

Several new dialogues have been initiated, involving different types of drug modalities to be tested with LaminarPace technology. A broader pipeline including several customer and therapeutic segments increases the business potential for Ziccum and significantly reduces the risk taking the technology to market.

One Big Pharma collaboration has reached the readout stage, and is subject to further evaluation, while one new dialogue has emerged, and one is in final negotiation for a paid study.

The mRNA/LNP Field

For mRNA/LNP projects, where Ziccum has generated very important data recently, more advanced discussions now include one more US Biotech Corporation (Biotech IV) where feasibility study negotiations are reaching final stages; the parties have agreed on the scope of the work plan and are currently reviewing legal terms. The modality to be tested is mRNA in a partner specific LNP formulation, where organ targeting is an extra technology edge for the mRNA/LNP partner portfolio.

The Big Pharma II Feasibility study, signed in July 2023, has reached completion and readout stage. Ziccum can report very good results for the technical parameters: encapsulation efficiency as well as LNP particle size and size distribution.

While the first part of this joint project has been completed, the Big Pharma II is currently assessing whether to initiate the second step.

The Feasibility study with Biotech Corp II achieved excellent results in first quarter 2024 as previously reported. The partner has not taken any decision for next potential steps as of yet.

Protein subunit vaccines

The Biotech Corp V dialogue has progressed, where the partner is planning to propose the scope for a Feasibility study within short. As Ziccum’s organization has very good knowledge in the field of subunit vaccines, it may be a welcome addition to the project portfolio and would provide further scientific support for the LaminarPace technology.

Lentivirus vaccines

The US-based CDMO Partner (CDMO I) project is currently on pause as communicated in the Q1 report, with the partner assessing which application may be utilized, to best achieve competitive advantages of the LaminarPace technology. There is great enthusiasm for Ziccum’s disruptive technology in the partner organization.

Protein Biopharmaceuticals

There are several new Big Pharma dialogues with large industry players having approached Ziccum recently. This has resulted in large forum presentations of the LaminarPace technology to scientific teams mainly in the UK, US and Sweden, and new project opportunities in review.

One of these partners, Big Pharma III has proposed a joint Feasibility project for testing of a protein pharmaceutical modality with LaminarPace, and to jointly make a scientific publication with Ziccum. Big Pharma III has important resources in vaccines as well as in therapeutics. This fruitful dialogue has progressed rapidly and is new to the Portfolio overview.

Ziccum’s CEO Ann Gidner: “We are delighted to keep on broadening our business scope with further serious industry dialogues with top class partners in Biotech and Big Pharma. The LaminarPace technology is here to solve the significant practical problems when advancing new biological modalities into real patient treatments – and the need for solutions is getting more into industry focus every day. In coming months, we hope to progress our collaborative pipeline further, while maintaining awareness of and respect for the many complex judgements needed when implementing new, unique technology in pharmaceutical development.

Ziccum Portfolio overview as of May 31st attached.