Iconovo AB (publ), that develops complete inhalation products for a global market today announces that the company’s Quality Management System (QMS) has been upgraded to meet the US Quality System Regulation (QSR 21 CFR 820) for medical devices. The company’s development and documentation process must comply with this FDA regulation to enable registration and marketing of medical device products in the US.

This achievement is a crucial step to obtain future US market access for all Iconovo drug device combination products including ICOres, ICOpre, ICOone and ICOcap.

In 2020, Iconovo’s QMS became compliant with the international ISO 13485:2016 standard for medical devices. Thus, the QMS also complies with the EU Medical Device Regulation. This has enabled Iconovo to develop drug device combination products that will be ready for registration on the European market.

“Iconovo have global ambitions for our inhalation platforms and US is the biggest pharma market in the world. Compliance with the US regulations is a key component to advance existing projects and will unlock even more opportunity in our partnering and business development process,” said Johan Wäborg, CEO for Iconovo.

Iconovo AB (publ), som idag utvecklar kompletta inhalationsprodukter för en global marknad, meddelar att företagets kvalitetssystem (QMS) har uppgraderats för att uppfylla USA:s Quality System Regulation (QSR 21 CFR 820) för medicintekniska produkter. Företagets utvecklings- och dokumentationsprocess måste följa denna FDA-förordning för att möjliggöra registrering och marknadsföring av medicintekniska produkter i USA.

Uppgraderingen är ett avgörande steg för att få framtida amerikanskt marknadstillträde för alla Iconovo-kombinationsprodukter för läkemedel, inklusive ICOres, ICOpre, ICOone och ICOcap.

Sedan år 2020 uppfyller Iconovo QMS kraven i den internationella standarden ISO 13485: 2016 för medicintekniska produkter. Därmed uppfyller QMS även EU:s förordning MDR för medicintekniska produkter. Detta har gjort det möjligt för Iconovo att utveckla kombinationsprodukter för läkemedel som är redo för registrering på den europeiska marknaden.

”Iconovo har globala ambitioner för våra inhalationsplattformar och USA är den största läkemedelsmarknaden i världen. Att uppfylla även det amerikanska regelverket gynnar våra pågående projekt, och kommer att öppna upp ännu fler möjligheter i vårt kund- och affärsutvecklingsarbete”, säger Johan Wäborg, VD för Iconovo.

Mats Johansson, styrelseledamot och den enskilt största ägaren i Iconovo AB (publ), har förvärvat 5 000 aktier för totalt 412 000 SEK.

Efter förvärvet uppgår Mats Johanssons innehav till 950 000 aktier som ägs både privat och via bolag, dessa motsvarar 10,7% av aktierna i bolaget.

 

 

Japan Patent Office has announced the intention to grant a patent (Notice of Allowance) regarding Iconovo’s inhalation device, ICOres. Iconovo has previously granted ICOres patents in Japan, USA, Sweden, Europe (EPO) and China. The new patent covers the technology used in many of Iconovo’s projects like generic Symbicort©.

Japan Patent Office has announced the intention to grant a patent (Notice of Allowance) regarding Iconovo’s inhalation device, ICOres. Iconovo has previously granted ICOres patents in Japan, USA, Sweden, Europe (EPO) and China. The new patent covers the technology used in many of Iconovo’s projects like generic Symbicort©.

“This new patent strengthens our patent protection on the very large and important Japanese market. This provides an opportunity to our partners to launch ICOres products in Japan”, says CTO Dr. Orest Lastow.

Iconovo AB (publ) meddelar att Japan Patent Office har informerat att de avser att godkänna (Notice of Allowance) ett patent avseende Iconovos inhalatorplattform, ICOres. Iconovo har sedan tidigare godkända patent på ICOres i Japan, Sverige, USA, Europa (EPO) samt Kina. ICOres är den inhalator som används i Iconovos stora kundprojekt där bland annat generisk Symbicort© ingår.

Iconovo AB (publ) meddelar att Japan Patent Office har informerat att de avser att godkänna (Notice of Allowance) ett patent avseende Iconovos inhalatorplattform, ICOres. Iconovo har sedan tidigare godkända patent på ICOres i Japan, Sverige, USA, Europa (EPO) samt Kina. ICOres är den inhalator som används i Iconovos stora kundprojekt där bland annat generisk Symbicort© ingår.

”Detta patent stärker vårt skydd på den stora och viktiga japanska marknaden. Det ger våra kunder en möjlighet att lansera ICOres-produkter i Japan”, säger Dr. Orest Lastow, CTO på Iconovo.

Mats Johansson, styrelseledamot och den enskilt största ägaren i Iconovo AB (publ), har förvärvat 5 000 aktier för totalt 421 400 SEK.

Efter förvärvet uppgår Mats Johanssons innehav till 945 000 aktier som ägs både privat och via bolag, dessa motsvarar 10,7% av aktierna i bolaget.

 

 

Expanded agreement doubles royalty potential

Key figures in TSEK unless otherwise indicated  Apr-Jun 2021 Apr-Jun 2020 Jan-Jun 2021 Jan-Jun 2020 Jan-Dec 2020
Net turnover 3,496 2,425 5,641 4,357 17,792
Operating profit/loss -6,586 -5,819 -13,912 -10,800 -16,717
Cash flow for the period -6,911 -9,697 -15,433 -13,429 -27,467
Earnings per share (SEK) before full dilution -0.86 -0.82 -1.77 -1.37 -2.20
Cash and cash equivalents 46,256 75,727 46,256 75,727 61,689
Equity 79,001 99,220 79,001 99,220 92,729
Number of shares at period-end 7,776,000 7,776,000 7,776,000 7,776,000 7,776,000
Number of royalty agreements** 6 3 6 3 5

**Number of agreements at the end of the period.

Significant events 1 April – 30 June

  • In May, Iconovo announced the expansion of its agreement with Amneal regarding generic Symbicort to include the key US and Chinese markets and the Nordic sales rights, more than doubling the potential for future annual royalty income.
  • In May, Iconovo communicated its 5-year business targets at its first Capital Market Day. By 2026, the Company expects to achieve sales of SEK 200 million, with an operating margin of 50%. The Company also announced its long-term strategy, with three strategic areas made up of the original core operation of generic inhalation product development plus the new areas of innovative inhalation product development and pharmaceutical sales in the Nordics.
  • In May, Iconovo entered into an agreement with Respiratorius for the development of an inhalation product for the treatment of COPD. The agreement includes a tiered fee for project work, with a total value of up to SEK 3 million.
  • In April, the Company announced that the United States Patent and Trademark Office issued an intention to approve (Notice of Allowance) a patent for the ICOone inhalation platform. Iconovo already has approved patents for ICOone in Sweden, Europe (EPO) and India.
  • The Board has been further strengthened. Ann Gidner was elected to the Board at the AGM, and Gunnar Gårdemyr has taken over the role of Board Chair.

Significant events after the end of the second quarter

  • In July, Iconovo carried out a directed share issue and raised SEK 75 million before issue expenses. The issue has been subscribed by a number of Swedish and international institutional investors, including Alcur Fonder, FE Fonder and Humle Fonder, as well as a number of existing shareholders, including Andra AP-fonden, Fjärde AP-fonden, Handelsbanken Fonder and Länsförsäkringar Fonder. The proceeds of the issue will primarily be used for acceleration and value creation activities and investments linked to the Company's new long-term strategy.
  • In July, Iconovo entered into an agreement with ISR (Immune System Regulation AB) for additional work on the ongoing inhaled COVID-19 vaccine project for the development of a nasal version of Iconovo’s ICOone inhaler. The additional work could provide up to SEK 4.9 million on top of the previous agreement. In addition, there is the possibility of future royalties.

A word from the CEO – Energised for growth

Long-term strategy with three areas In May, Iconovo held its first ever Capital Market Day, during which we launched our new long-term strategy. As a company, we are uniquely positioned to develop additional areas around inhalation, and we see great opportunities for growth by broadening our offering. Our future is now being shaped in three areas – Generic Inhalation Products, Innovative Inhalation Products and Pharmaceutical Sales in the Nordics.

An important area is the development of new, innovative inhalation drugs. These may be entirely new drugs, or new formulations of substances that were previously available only as injections, for example. We call this strategic area Innovative Inhalation Products. In the last six months, Iconovo has entered into three agreements in this innovative area, clearly demonstrating that our business model can be used in a very attractive way. Our offering allows our partners to invest in an inhalable drug in a high-quality, innovative inhaler – something that very few companies in the world can match.

In June, we further demonstrated the potential of our innovative projects when we entered into a supplemental agreement with ISR for the development of a nasal COVID-19 vaccine in a new Iconovo platform called “ICOone Nasal”. The order could provide Iconovo with an additional SEK 4.9 million on top of previously agreed amounts.

Development of generic asthma and COPD drugs is an area in which Iconovo is already well established, and it remains an important part of our operations. We anticipate significant future revenue from this area, primarily through royalties. We possess globally recognised expertise and can attract generics business on the global stage. The strategic area Generic Inhalation Products will be pursued with a continued focus on winning new business and continued deliveries towards the first market launches, expected in 2023.

When entering into development agreements with generic companies around the world, it is seen as very positive if you have a lot to gain from developing a fantastic product yourself. We therefore have a dual reason to sell generic products in the Nordic market ourselves.

This not only makes as a more attractive business partner, but becoming a Nordic pharmaceutical company helps us to build our own profitable drug portfolio. The strategic area Nordic Pharmaceutical Sales is being kicked off with establishment of Iconovo Pharma in 2021–2022. The first drug product launched is expected to be generic Symbicort in 2023, with a current market value of SEK 900 million in the Nordics.

Successful capital raising In early July, a directed share issue worth SEK 75 million was carried out. Several of our existing major shareholders took part in the issue, including Andra AP-fonden, Fjärde AP-fonden, Handelsbanken Fonder and Länsförsäkringar Fonder. We also specifically targeted Alcur, FE Fonder and Humle Fonder, which are known for investing in quality small companies with high potential and growth.

Five-year targets A strong cash position enables additional efforts and drive behind each of our three strategies. The strategies form the basis and plan for the work that will lead us to our set targets for 2026. We will reach a turnover of SEK 200 million from our generic projects and from Nordic pharmaceutical sales. In addition to this, the innovative projects with ISR have a potential upside worth SEK 100 million in 2026. Our business model is expected to lead to 50% operating margin from operations. The above targets are based on the projects we have right now, but we have also set an additional target of entering into 1–3 new customer agreements per year during the period up to 2026. Through new agreements, we can exceed the targets, and that is precisely why we want to invest now. To this end, we chose to raise capital via a directed issue.

Now that the strategy is in place, our focus is fully on implementation. We are now energised, well-funded and ready to focus heavily on our three strategic areas to maximise the value of our operations.

Johan Wäborg, CEO

Iconovo AB (publ), a company developing complete inhalation products for a global market, today announced that it has received an order from the immunotherapy company ISR Immune System Regulation AB (ISR), a subsidiary of ISR Immune System Regulation Holding AB (publ), for additional work for the ongoing project with inhaled COVID-19 vaccine with a development of a nasal version of Iconovo's inhaler ICOone. The additional order may give Iconovo up to 4.9 MSEK in addition to previously announced agreement.

The order covers the development of a nasally administered COVID-19 vaccine that will become a new fast track to the market due to a faster development process. The project for a nasal administration of a COVID-19 vaccine will use ICOone Nasal, which is a new nasal platform based on ICOone. It is a unique and proprietary nasal powder delivery device.

ISR and Iconovo pushes the project for an inhaled COVID-19 vaccine forward with high speed. Therefore, ISR has decided to accelerate development by adding a nasally administered vaccine that provides a faster path through the clinical studies. This COVID-19 vaccine, with administration to the nasal cavity, is meant to be a fast track that can either lead to a separate registration or it could pave the way for an orally inhaled vaccine for administration to the lung. The new nasal vaccine will be developed by Iconovo in the new platform ICOone Nasal.

The new agreement gives ISR an exclusive global right to use ICOone Nasal under the current agreement as a line extension to ICOone, for the treatment of COVID-19 and its variants with a technology based on so-called spike proteins with an adjuvant. Under the current agreement, ISR also has a future option to use its vaccination technology in ICOone in influenza, RS-virus and new strands of covid-virus vaccines based on the same technology.

The total value of the order is 10.4 MSEK, which is 4.9 MSEK in addition to previously communicated contractual sums. Iconovo will contractually develop a nasal vaccine and manufacture clinical trial material to a phase 1 study that takes priority into phase 1 over the inhaled lung product. Payments are expected to be divided into 9.1 MSEK over the coming six months and the remaining amount over the next 24 months. Upon signing of the order, an initial payment of 1.3 MSEK will be paid.

"This order provides a great opportunity to evaluate the new platform ICOone Nasal in a clinical study for COVID-19. We give the project the highest priority to support ISR in their efforts to advance the project according to the aggressive timelines required during a pandemic. This project could be the start of a paradigm shift that opens the door to inhaled vaccines instead of injectable vaccines. A shift where Iconovo is well positioned to take the lead", says Johan Wäborg, CEO of Iconovo.

An inhaled formulation for nasal or lung administration gives important benefits such as ease of use, cheaper transportation, storage without the need for refrigeration and no handling of needles and syringes. Removing the need for refrigeration and the handling of contagious material represent a large savings potential and can potentially eliminate the risk of spreading disease through infected needles. Another important benefit is that the vaccine directly reaches the airways and provides both a local protection in the airways and an activation of the systemic immune defense.

”The platform of ICOone with its flexibility enables a rapid, affordable and effective development of a SARS-CoV-2 vaccine for the respiratory tract. The platform can make ISR's vaccine available on the global market shortly after conducting clinical studies. The collaboration is now deepening and broadened to include both nasal and lung administration, which we see as a great advantage, as different respiratory pathogens may have different entry ports in the airways. We see the collaboration with Iconovo as a long-term partnership with the aim of establishing a series of different vaccines”, says Ola Winqvist, CEO of ISR.

About ISR

ISR is an innovation-driven development company of pharmaceuticals within immunotherapy. The business idea is to convert preclinical immunological research to clinical development stimulating the the immune system to fight chronic infections like HIV, HBV and cancer by developing the company’s pipeline of immunostimulants Immunolider and Immunorheliner and utilize the immune system to develop designer vaccines. The company has its headquarter in Stockholm. Mangold Fondkommision AB is the certified advisor and can be reached at telephone +46 8 503 01 550.

About ICOone®

ICOone is a unique, patented dry powder inhaler for single use. The smart design generates an ultra-low manufacturing cost combined with simple and discreet use. It is particularly suitable for short-term treatment and as-needed use as it provides an unsurpassed low treatment cost and price point for treatments with a low number of doses. The simple design also enables patients and caregivers to learn how to handle the inhalers with minimal training. ICOone can deliver large inhalation doses that are well protected against moisture, an important factor for many biomolecules.

About ICOone® Nasal

ICOone Nasal is a unique and patented nasal powder delivery device driven by the inhalation of the user for single use. The smart design generates an ultra-low manufacturing cost combined with simple and discreet use. It is particularly suitable for short-term treatment and as-needed use as it provides an unsurpassed low treatment cost and price point for treatments with a low number of doses. The simple design also enables patients and caregivers to learn how to handle the nasal delivery device with minimal training. ICOone Nasal is driven by the inhalation of the user that gives an even and natural distribution of the powder on the nasal mucosa. The patented design gives a stable product avoiding the need for refrigerator-cold transport and minimize the need for preservatives.

Iconovo AB (publ), som utvecklar kompletta inhalationsprodukter för en global marknad, tillkännagav i dag att de har avtalat med immunterapibolaget ISR Immune System Regulation AB (ISR), ett dotterbolag till ISR Immune System Regulation Holding AB (publ), om tilläggsarbete för det pågående projektet med inhalerat covid-19 vaccin med utveckling av en nasal version av Iconovos inhalator ICOone. Tilläggsuppdraget kan ge Iconovo upp till 4,9 MSEK utöver tidigare avtal.

Ordern omfattar en utveckling av ett nasalt administrerat covid-19-vaccin som blir nytt snabbspår till marknad p.g.a. en snabbare utvecklingsprocess. Projektet med det nasalt administrerade covid-19-vaccinet avser att använda ICOone Nasal, som är en ny nasal plattform baserad på ICOone. Det är en unik och patentskyddad nasal inhalator för pulverformuleringar.

ISR och Iconovo driver projektet för inhalerat covid-19-vaccin framåt med högsta hastighet. ISR har därför valt att accelerera utvecklingen genom att lägga till ett nasalt inhalerat vaccin som ger en snabbare väg genom studierna. Detta covid-19-vaccin med administration till näshålan, är tänkt att bli ett snabbspår som antingen kan leda till en separat registrering alternativt kan det bana väg för ett oralt inhalerat vaccin, för administration till lungan. Den nya nasala produkten kommer att utvecklas av Iconovo i nya plattformen ICOone Nasal.

Det nya avtalet ger ISR en exklusiv global rättighet att använda ICOone Nasal under det nuvarande avtalet som en vidareutveckling av ICOone, för behandling av covid-19 och dess varianter med en teknologi baserad på så kallade spike-proteiner med adjuvans. I det nuvarande avtalet har ISR också en framtida option att använda sin vaccinationsteknologi i ICOone inom influensa, RS-virus och nya covid-vacciner baserade på samma teknologi.

Värdet på ordern är totalt 10,4 MSEK vilket är 4,9 MSEK utöver tidigare kommunicerade avtalssummor. Iconovo ska kontraktsutveckla ett nasalt vaccin samt leverera en nasal klinisk prövningsprodukt till en fas 1-studie som går med prioritet in i en fas 1 studie före den lunginhalerade produkten. Betalningarna väntas vara fördelade på 9,1 MSEK under den närmaste sexmånadsperioden och resterande belopp under efterkommande 24 månader. Vid avtalets ingående utlöses en initial betalning på 1,3 MSEK.

“Detta uppdrag ger en fin möjlighet att utvärdera nya plattformen ICOone Nasal i en klinisk studie på Covid-19. Vi ger projektet högsta prioritet för att hjälpa ISR framåt enligt de offensiva tidslinjer som krävs under pandemin. Projektet kan utgöra starten på ett paradigmskifte som öppnar upp för att i framtiden inhalera i stället för att injicera vacciner. En utveckling som Iconovo är väl positionerat att ta ledningen i”, säger Johan Wäborg, VD, Iconovo.

En inhalerad beredning för nasal- eller lungadministration ger viktiga fördelar som till exempel lättare användning, billigare transporter, lagring utan krav på kylskåpstemperatur och man slipper hantering av nålar och sprutor. Att avlägsna behovet av kylskåpstemperatur och hantering av smittosamt avfall ger en stor kostnadsbesparing och kan potentiellt eliminera risken för sjukdomsspridning genom infekterade nålar. En annan viktig fördel är att vaccinet når direkt till luftvägarna och ger både ett lokalt skydd i luftvägarna samtidigt som kroppens systemiska immunförsvar aktiveras.

"ICOone plattformen med dess flexibilitet möjliggör ett snabbt, prisvärt och effektivt framtagande av ett vaccin mot SARS-CoV-2 för luftvägarna. Plattformen kan göra ISRs vaccin tillgängligt på den globala marknaden kort efter genomförande av kliniska studier. Samarbetet fördjupas nu och breddas till att omfatta både nasal och inhalations administration, vilket vi ser som en stor fördel, där olika luftvägspatogener kan vara i behov av fokus på olika inträdesportar vid vaccinframställningen. Vi ser samarbetet med Iconovo som ett långsiktigt partnerskap i syfte att etablera en serie av olika vacciner" uppger Ola Winqvist, VD, ISR AB.

Om ISR

ISR är ett innovationsdrivet läkemedelsutvecklingsbolag inom immunterapi. Bolagets affärsidé är att omvandla preklinisk immunologisk forskning till klinisk prövning för att med hjälp av ett stimulerat immunsystem bekämpa kroniska infektioner som HIV, HBV och cancer genom att utveckla bolagets pipeline av immunstimulerande Immunolider och Immunorheliner och ta vara på immunsystemet genom att utveckla designande vaccin. Bolaget har sitt huvudkontor i Stockholm. Mangold Fondkommision AB är bolagets Certified Adviser och nås på +46 8 503 01 550

Om ICOone®

ICOone är en unik och patenterad torrpulverinhalator avsedd för engångsbruk. Den smarta konstruktionen ger en ultralåg tillverkningskostnad kombinerad med en enkel och diskret användning. Den är speciellt lämplig för korttidsbehandlingar och sällandoserings-behandlingar då den ger en oöverträffat låg behandlingskostnad och prispunkt för behandlingar med få doser. Den enkla konstruktionen gör också att patienter och behandlare kan lära sig hantera inhalatorn med minimal träning. ICOone kan leverera stora inhalationsdoser som är väl fuktskyddade, vilket är viktigt för många biomolekyler.

Om ICOone® Nasal

ICOone Nasal är en unik och patenterad inhalationsdriven nasal inhalator för torrpulver avsedd för engångsbruk. Den smarta konstruktionen ger en ultralåg tillverkningskostnad kombinerad med enkel användning. Den är speciellt lämplig för korttidsbehandlingar och sällandoseringsbehandlingar då den ger en oöverträffat låg behandlingskostnad och prispunkt för behandlingar med få doser. Den enkla konstruktionen gör att patienter och behandlare kan lära sig hantera nasala inhalatorn med minimal träning. ICOone Nasal är en inhalationsdriven nasal pulverinhalator som ger en jämn och naturlig fördelning av pulvret över nässlemhinnan. Den patentskyddade designen ger en stabil produkt som undviker krav på kylskåpskall transport och minimerar behovet av konserveringsmedel.

Mats Johansson, styrelseledamot och den enskilt största ägaren i Iconovo AB (publ), har förvärvat 5 000 aktier för totalt 380 000 SEK. Efter förvärvet uppgår Mats Johanssons innehav till 940 000 aktier som ägs både privat och via bolag, dessa motsvarar 10,6% av aktierna i bolaget.