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CombiGene AB (COMBI)🇾đŸ‡Ș

Biotek
#61

COMBIGENE: GRUNDARE SÅLT NÄSTAN 0,5 MLN AKTIER

STOCKHOLM (NyhetsbyrÄn Direkt) En av grundarna av Combigene, Lars Thunberg, sÄlde i mÄndags nÀstan 496.000 aktier i det First North-listade forskningsbolaget för drygt 0,6 miljoner kronor.

Det framgÄr av inrapportering till Finansinspektionens insynsregister.

Han Àger lite fÀrre Àn 4,5 miljoner aktier efter affÀren, enligt ÀgardatatjÀnsten Holdings.

Lars Thunberg sitter i Combigenes styrelse sedan 2006 och har under en period, 2013-2014, Àven varit ordförande.

Edit: Vi fÄr vel tÄle et lite innsidesalg pÄ ca 10%.

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#62

I fÞlge en av aksjonÊrene pÄ facebook gruppa for CombiGene sÄ skal visstnok salget vÊre ifra et selskap som eies av Lars Thunberg som er under avvikling, og dermed utenfor hans kontroll. Har ikke sjekket detaljene rundt dette, men personen som har skrevet det har ihvertfall vÊrt troverdig pÄ sine tidligere innlegg. Kan sjekke nÊrmere pÄ dette senere nÄr jeg har litt mer tid tilgjengelig.

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#63

Ser ut til at Lars Thunberg selv har kommentert salget pÄ linked inn. VÊrt inne selv Ä sjekket og kan se at det stemmer(skjermbilde nedenfor).

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#64

Nytt nummer av Combigenes nyhetsbrev GenevÀgen er ute! Ser ut til Ä vÊre spennende lesning.

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https://issuu.com/pub10/docs/ingeneious_nr2_2020?fr=sODg5NzE3ODcwNQ

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#65

Mye ny og spennende info i siste nyhetsbrev. SelvfÞlgelig veldig langt frem for CGT2 men artig Ä fÄ noen estimater pÄ bordet. Combigene sin marketcap er rundt 100 MSEK for Þyeblikket.

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#66

Ny artikkel med intervju av Jan Nilsson i Biostock. Ser de repeterer igjen at mÄlet er Ä vÊre i klinikken med CG01 for epilepsi lÞpet av 2022.

Jan Nilsson svarer blant annet pÄ spÞrsmÄlet:

Hur stort Àr det globala patientunderlaget för era tvÄ kandidater och hur stor del av dessa Àr mÄlbilden att ni skall kunna behandla efter ett ni eventuellt lyckas nÄ marknad?

Svar nedenfor:

“– Varje Ă„r berĂ€knas cirka 47 000 lĂ€kemedelsresistenta patienter med fokal epilepsi tillkomma i USA, EU5, Japan och Kina. Vi gör bedömningen att det Ă€r realistiskt att 10-20 procent av dessa patienter skulle kunna behandlas med CG01. Om man för exemplets skull antar att terapikostnaden per patient ligger nĂ„gonstans mellan 134 000 USD och 200 000 USD, vilket Ă€r lĂ„gt jĂ€mfört med godkĂ€nda genterapilĂ€kemedel, ger det en försĂ€ljning mellan 750-1 500 miljoner USD Ă„rligen.”

“– Partiell lipodystrofi Ă€r en mycket sĂ€llsynt sjukdom som idag saknar verksamma behandlingsmöjligheter. Man uppskattar att det idag finns cirka 500 patienter i USA och 300 patienter i EU och att patientpopulationen förvĂ€ntas vĂ€xa med knappt fyra procent om Ă„ret. Om man antar att CGT2 kommer att behandla mellan 25 och 50 procent av patienterna och att behandlingen per patient ligger pĂ„ 1,5 miljoner USD i USA och 1,3 miljoner USD i Europa blir den totala försĂ€ljningspotentialen mellan 700-1 450 miljoner USD.”

Link til artikkelen. Veldig mye bra!

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#67

Ny oppdatering med ny milestone oppnÄdd av selskapet. Bygger videre sten for sten.

Cobra Biologics delivers final plasmids for production of CG01 in CombiGene’s epilepsy project

Further milestone paves the way for production of novel gene therapy drug candidate designed to treat drug-resistant focal epilepsy

Keele, UK and Lund, UK, 13th July 2020:
Cobra Biologics (Cobra), part of the Cognate BioServices family, an international Contract
Development and Manufacturing Organisation (CDMO) for biologics and pharmaceuticals, and CombiGene AB (publ) (CombiGene), the leading gene therapy company in the Nordic region, today announced that Cobra has successfully produced and supplied two further DNAplasmids for the production of CombiGene’s gene therapy drug candidate CG01, which is being developed for the treatment of drug-resistant focal epilepsy. This successfully completes delivery of all plasmids required to progress to the next phase of the project.
The production of CG01, is dependent on manufactured and specifically modified plasmids. All three plasmids delivered by Cobra are key components of the gene therapy vector tasked with “transporting” CG01’s active substances NPY and Y2 into the patient’s brain tissue. To produce CG01 the plasmids are introduced into specific cells that act as “the factory” to produce the CG01 compound which will then be purified through a series of advanced techniques. The development of the manufacturing process for CG01, is thereby significantly more complex and time consuming than is the case for traditional small molecule medicines.
The first plasmid was delivered in April and with Cobra now delivering the two remaining plasmids, CombiGene is ready to begin production of CG01 as soon as the final manufacturing process is defined.

Karin Agerman, Chief Research and Development Officer, CombiGene:
“The successful production and delivery of the last two of the three vital plasmids
is another milestone in our collaboration with Cobra in the CG01 project. Since the start of our collaboration, Cobra has consistently delivered according to plan, which makes us feel great confidence in our continued collaboration in the CG01 project.”

Peter Coleman, Chief Executive, Cobra Biologics:
“This is a further milestone in the progression of the GGO1 project and it gives me great
pride in Cobra playing such a key role, drawing on our many years’ of experience and expertise in gene therapy production. We are looking forward to continuing to work with the CombiGene team on the next stages of manufacture.”

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#68

CombiGene makes a MSEK 15,5 directed share issue to the Dutch specialized Life Science investor NYIP

CombiGene AB (publ) (“CombiGene” or the “Company”) has today decided to carry out a directed share issue of 21,588,125 units, each consisting of one share and one warrant of series TO5, at a price of SEK 0,72 per unit, corresponding to an initial investment of EUR 1.5 million or approximately SEK 15,5 million, before issue costs, to the Dutch specialized Life Science investor NYIP ("Nyenburgh Holding BV "). The warrants of series TO5 are issued free of charge and have the same terms and conditions as the Company’s series TO4 warrants, meaning that the warrants of series TO5 can be exercised for subscription of shares during the period 16 November 2020 – 30 November 2020 at a subscription price corresponding to 10 days volume-weighted average price for the period 2 November 2020 – 13 November 2020, with a discount of 30 percent, but not less than SEK 0.5 and not more than SEK 0.7 per new share. Upon full exercise of all warrants, the Company will be receiving a maximum of approximately SEK 15 million, kronor, before issue costs.

The Board’s decision to issue units, consisting of shares and warrants, is based on authorization from the Annual General Meeting held on June 29, 2020. The subscription price corresponds to a discount of approximately 11 percent compared to the volume-weighted price over a period of ten trading days until 31 July 2020. The Board of Directors has assessed that the subscription price and other terms of the issue are market-based, especially in the light of the current market situation. The purpose of the directed issue and the reason for deviation from the shareholders’ preferential rights is to cost-effectively bring capital from a strategic investor to the Company.

David .Q.J. Van Mastwijk , Director Investments, comments:
“NYIP has decided to invest in CombiGene in this crucial phase of their development with the epilepsy project going into the next steps of development. With a strong rationale behind their lead compound CG01, they can be the first to develop a gene therapy for epilepsy, a disease that has far reaching implications for its patients and caregivers. We
trust that CombiGenes outstanding team will carry this project forward
and create substantial value for patients and all other stakeholders in CombiGene.”

“Through the directed issue to NYIP, CombiGene strengthens its financial position in a decisive way. The issue itself brings to the Company just over SEK 15 million. In addition, CombiGene may be receiving approximately SEK 54 million in autumn 2020 through the warrants of series TO3, TO4 and TO5. With this capital, we are well equipped to continue the development of our epilepsy project CG01 and our lipodystrophy project CGT2 according to plan,” said CombiGenes CEO Jan Nilsson in a comment. “I am also very pleased that NYIP has chosen to invest in CombiGene. NYIP has a great deal of experience investing in European life science companies and will bring CombiGene great know-how and experience in addition to the capital they invest in the Company.”

The new issue of shares entails a dilution of approximately 14.7 percent in relation to the number of shares and votes in the Company and increases the share capital of CombiGene by SEK 2,158,812.5 to SEK 14,721,013.2 and increases the number of shares in the Company by 21,588,125 shares to 147,210,132 shares


Each series TO5 warrant entitles to subscription of one share, as a result of which the Company’s share capital may increase by a further maximum of SEK 2,158,812.5 and the number of shares may increase by a further maximum of 21,588,125 shares.

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#69

Ser ut til at Nyenburgh velger nok en gang Ä dilte etter laplagam sine hovedinvesteringer ved Ä sku inn penger. Satser pÄ at de denne gangen fÞlger sin pÄstÄtte strategi med Ä vÊre langsiktige slik at de kan tjene penger denne gangen :slight_smile:
For CombiGene sin del sÄ tenker jeg dette uansett er nyttig. Jo mer penger de fÄr inn nÄ pÄ vei mot klinisk, jo bedre er det. SÄ fÄr vi ta det som en bonus dersom de mot formodning skulle bli med videre som en nyttig investor partner med et eventuelt pengebehov pÄ senere tidspunkt.

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#70

Enda mer godsaker. MÄ vel snart begynne Ä gÄ skikkelig denne :slight_smile:

Resultat frÄn CombiGenes celltropismstudie bekrÀftar att CG01 enbart nÄr till nervcellerna i hippocampus

CombiGene har nyligen framgÄngsrikt slutfört en sÄ kallad celltropismstudie med företagets genterapi CG01, som utvecklas för behandling av lÀkemedelsresistent fokal epilepsi. CG01 Àr avsett att nÄ nervcellerna i hippocampus, det vill sÀga de celler som utlöser de epileptiska anfallen. Den nu genomförda tropismstudien visar att CG01 fungerar precis som Àmnat: den tas upp i nervcellerna i hippocampus, men inte i stödjecellerna, de sÄ kallade gliacellerna.

Resultaten frÄn studien Àr mycket uppmuntrande eftersom de Àr ytterligare en bekrÀftelse pÄ att CG01 nÄr hjÀrnans celler som avsett. Kunskapen frÄn tropismstudien ger en detaljerad förstÄelse för hur CG01 fungerar och ger svar pÄ frÄgor kring lÀkemedelskandidatens tropism som regulatoriska myndigheter har stÀllt.

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#71

Risk/reward blir bare bedre og bedre for hver melding som kommer all den tid kursen ligger og vaker rundt 100 MSEK i market cap. Nok en strÄlende nyhet og derisk!

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#72

Rulller pÄ videre.

CombiGene has completed a successful pilot production of CG01 using Viralgen’s suspension manufacturing platform

CombiGene AB (publ) has recently completed a successful pilot production of CG01 together with Viralgen. The data supports a commercially viable manufacturing strategy using the Pro10 platform. Viralgen’s proprietary suspension recombinant AAV (rAAV) production platform is based on a technology developed by AskBio that has recently been made available via Viralgen and their cGMP facility. The process based on the Pro10TM cell line enables a very cost-effective way to scale up production volumes from small volumes intended for research and development to full-scale commercial volumes of GMP quality. CG01 is developed for the treatment of patients with drug-resistant focal epilepsy.

Large-scale production of gene therapeutic drugs was for a long time a challenge for the entire industry. Existing production methods, relying on adherent production, have been excellent for producing small volumes of gene therapeutic drugs, but have inherent and significant difficulties in scaling up production volume. For CombiGeneÂŽs drug candidate CG01, this posed particular difficulties as it is developed for a significant patient population compared to many other gene therapies. The company estimates that nearly 10,000 patients annually will be candidates for treatment with CG01.

The Spanish company Viralgen, whose production platform for AAV is based on AskBio’s Pro10TM production method, established a manufacturing facility in San Sebastian which received cGMP certification for manufacturing of AAV in 2019. The manufacturing process is based on a suspension platform that proved to be a technology that is very well suited for scaling up from small research volumes to large commercial volumes with GMP quality. The outcome of the pilot study that CombiGene has now conducted together with Viralgen is very positive. The data supports a commercially viable manufacturing strategy using the Pro10 platform.

CombiGene will now evaluate all aspects of the pilot study before the company makes a final decision on if the production method should be switched already now to suspension production.

Karin Agerman, Chief Research and Development Officer, CombiGene:
“The data is very exciting and opens up the possibility for a scalable manufacturing strategy all the way through to a commercial production already at this early stage in development.”

“We are very excited about this collaboration with CombiGene and we are committed to their success. Our production platform brings great value to our customers by allowing fast, large-scale development from preclinical, clinical to commercial gene therapy products. CombiGene’s work in epilepsy brings great hope for patients suffering from this disease” Javier Garcia, Viralgen®s CEO , quoted.

About CombiGene AB
www.combigene.com
CombiGene’s vision is to offer patients affected by severe life-changing diseases opportunities for a better life through innovative gene therapies.

CombiGene’s business concept is to develop effective gene therapies for serious diseases that today lack adequate treatment methods. Research assets are taken in from a network of external researchers and developed further up to clinical concept verification. Drug candidates for common diseases will be co-developed and commercialized through strategic partnerships, while CombiGene may drive the development and commercialization in-house for medicines aimed at limited patient populations. The company is public and listed on the Nasdaq First North Growth Market and the company’s Certified
Advisor is FNCA Sweden AB, +46 (0)852 80 03 99,
info@fnca.se.

About Viralgen
Viralgen is a CDMO born as a joint venture between AskBio and Columbus Venture Partners, combining decades of technology and drug development experience in multiple platforms to support best-in-class service offerings to the gene therapy market.
Viralgen was created in 2017 to respond to the unmet need for manufacturing of gene therapies, with the goal to help broaden access to these life-saving therapeutics and to contribute to the advancement of health and human welfare around the world. We specialize in the production of rAAV viral vectors, and have built an optimized facility in San Sebastian, Spain that maximizes throughput and efficiency of our proprietary Pro10ℱ suspension manufacturing platform, enabling industry-leading scalability, reproducibility, and speed to market.
Through our superior technology platform, we deliver industry-leading titers and cGMP-certified quality for all AAV serotypes to our client partners, optimize the cost-of-goods, and accelerate clinical development and commercialization of life-saving genetic medicines.

Viralgen new commercial facility will be in production by the end of 2021 in San Sebastian (Spain).

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#73

Skal nok se @laplagam at kursen og epileptikere har en spennende fremtid innen dette studiet med spanjolene👌

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#74
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#75
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#76

Forsiktig med Ä hÞre pÄ den gjengen der. De har et salg i en av deres trader der kursen aldri har vÊrt innom


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#77

Ja jeg ville selv aldri handlet pÄ den meldingen der :slight_smile: Burde lagt ved en disclaimer sÄ takk som pÄpekte det :+1:

#78

Exercise period for warrants of series TO3 in CombiGene AB (publ) begins today

Today, the exercise period for subscription of shares in CombiGene AB (publ) (“CombiGene”) begins on the basis of warrants of series TO3. One warrant of series TO3 entitles to subscription for one new share in CombiGene from and including 17 August 2020 up to and including 31 August 2020 at a subscription price of SEK 0.6 corresponding to the volume-weighted average price of the shares in CombiGene during the period from and including 3 August 2020 up to and including 14 August 2020 with a discount of 30 percent, because the subscription price per share could not be higher than SEK 0.6.

On February 18, 2020, CombiGene issued 26,284,180 warrants of series TO3 and on April 24, CombiGene issued an additional 4,000,000 warrants of the same series, in total CombiGene has issued 30,284,180 warrants of series TO3. In the case of full subscription at the subscription price of SEK 0.6, CombiGene will be granted SEK 18,170,508 before issue costs, with the total number of shares increasing by 30,284,180 shares to 155,906,187 shares and the share capital increasing by SEK 3,028,418 to SEK 15,590,618.7, corresponding to a dilution effect of approximately 19.42 percent of CombiGene’s share capital and votes. Dilution effect refers to the number of newly issued shares and additional votes as a result of full exercise of the warrants of series TO3 in relation to the total number of shares and votes in CombiGene after the new shares have been registered.

Please note that if the warrants of series TO3 are not exercised for subscription of shares by August 31, 2020 at the latest or disposed of by August 27, 2020 at the latest, they will expire and lose their value and will be cleared from the VP account or depositary.

The application form, the Board’s report and auditor’s statement as well as the full terms and conditions for the warrants of series TO3, a copy of CombiGene’s Articles of Association, a copy of the annual report containing the most recently established balance sheet and income statements, including the audit report for the financial year, are available at the Company and on the Company’s website, www.combigene.com.

The results of the exercise period will be announced in September 2020.

#79
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#80

De jobber pÄ, veldig bra!

https://combigene.com/en/news-and-reports/cobra-biologics-completes-production-of-master-cell-banks-for-combigenes-epilepsy-gene-therapy-drug-candidate/

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