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CombiGene AB (COMBI)🇸🇪

For en reise dette kan bli om både CG01 og CGT2 går inn! :moneybag: :moneybag: :moneybag:

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Pent, på tide å øke om vi får et dip til mot 10 i dritt klima.

Ser ut som en veldig bra samarbeidspartner de har funnet her:

– Professor MacDougald and his clinical partner, Dr Elif Oral, have a complete team working in the lipodystrophy field and their extensive knowledge and technical expertise will benefit CombiGene’s CGT2 project. MacDougald Lab is a leading research lab in adipose tissue biology. The University of Michigan Metabolism, Diabetes and Endocrinology Division has become a leader in the treatment of lipodystrophy syndrome thanks to Dr Oral’s long-standing clinical interest in this disease.

Og det er befriende med et lite biotek som har finansiell styrke til å satse på og utvide og utvikle pipen sin:

– Overall, I am of course very pleased that we can go ahead with full speed in both of our projects, whilst also having the financial muscles to actively seek new interesting projects to inlicense.

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Ja, går denne og til helvete så forstår eg ingenting.

Denne og Cereno er dei eg har som er validerit av BF, resten er bare å avskrive ser det ut som.

Så får vi håpe at de to kan bli en «10 baggare» som kan redusere biotapet mitt og muligens få det i break Even.

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Her bygges det pipeline :chart_with_upwards_trend:

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Løfter frem denne igjen

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CombiGene’s and Neurochase’s preclinical study provides valuable information for the upcoming long-term studies in toxicology and biodistribution

STOCKHOLM — On June 28, 2021, CombiGene (“CombiGene”, “the Company”) announced that the Company, together with its partner Neurochase, had started the work to optimize the administration of CG01 in a preclinical pilot study in a large animal model. CombiGene can today announce that the practical part of the study has now been completed.

In the study, the administration of CG01 has been evaluated in terms of, among other things, injection volume and injection rate. The study provides valuable information of the Neurochase injection device for the upcoming long-term studies in toxicology and biodistribution in large animals.

“CombiGene continues to break new ground within the framework of the CG01 project,” said Pernilla Fagergren, Project Manager at CombiGene. “No one has previously developed a gene therapy for the treatment of drug-resistant focal epilepsy. We have now gained new knowledge that is valuable for the upcoming long-term studies in toxicology and biodistribution in large animals.”

Since CombiGene and Spark Therapeutics in October 2021 entered an exclusive collaboration and licensing agreement for CG01, the two companies have jointly reviewed the future development of the project with the ambition to establish the best path forward.

The most significant outcome of this review is the decision to expand the clinical development program to include clinics in the U.S. as well as in Europe. The U.S. is the world’s largest pharmaceutical market and to establish a clinical presence there adds much further strength to the CG01 project.

In order to prepare CG01 to meet the needs of an expanded submission that also includes the U.S., the remaining preclinical program will be expanded and, in some parts, complemented with additional studies. In practice, this means that the preclinical part of CG01 will take longer to finalize.

During the remaining part of the preclinical program, all CG01-related R&D activities that CombiGene is running, internal as well as external, will be agreed upon and approved by Spark, who also assumes all agreed costs. As CG01 enters the clinical phase, Spark will take over the responsibility for the continuation of the project and thus also bear all costs during this development phase.

About CG01
CG01 is a unique gene therapy candidate aimed at a large patient population to solve a global need in epilepsy treatment. Epilepsy is a major global medical problem with approximately 47,000 drug-resistant patients with focal epilepsy estimated to be added each year across the US, EU4, UK, Japan, and China. CG01 is in a late preclinical stage. The production platform, jointly developed by CombiGene and its partners Cobra Biologics and Viralgen, is scalable and designed to provide material for preclinical and clinical, and future commercial production. CombiGene has signed an exclusive collaboration and licensing agreement for CombiGene’s CG01 project with Spark Therapeutics.

Horizon 2020
CombiGene’s lead project CG01 has received funding from the European Union’s Horizon 2020 research and innovation program under grant agreement No 823282.

About Spark Therapeutics
At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases. We currently have four programs in clinical trials. At Spark, a member of the Roche Group, we see the path to a world where no life is limited by genetic disease. For more information, visit www.sparktx.com, and follow us on Twitter and LinkedIn.

About Neurochase
www.neurochase.com
Neurochase, founded by Professor Steven Gill, aims to bring transformative targeted therapies to patients with neurological diseases using state of the art technology. The company’s team specializes in creating bespoke therapeutic strategies for the direct delivery of therapies using Convection Enhanced Delivery (CED). Neurochase provides accurate, targeted and safe direct drug delivery to the CNS and develop globally scalable treatment strategies and solutions for the pharmaceutical and biotech industry. Neurochase Ltd. is a Registered Company Number 12428919.

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CombiGene’s pilot study, which is aimed at optimising the administration of the drug candidate CG01, has given the company valuable insights for future development steps. The path towards clinical studies, which will take place with support from partner Spark Therapeutics, thus takes another step forward. BioStock contacted the company’s CEO Jan Nilsson who talks about the collaboration with Spark, and how the company views its intensified investment in business development.

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Ser ut som de har ambisjoner om å bredde ut pipen. Og vi vet at de er en interessant aktør for partnerskap ref Spark-dealen.

Kan bli en multibagger med tiden det her

In recent months, in addition to focusing on concluding the preclinical programme, you have intensified your focus on business development. Can you elaborate on this?

– Our focus in identifying new possible projects is based on two things. Technologically, we are most interested in AAV vectors because this is an area where we consider ourselves very knowledgeable. In terms of indications, we primarily look at diseases within the central nervous system and metabolic diseases where we also have good knowledge. At the same time, we will keep a very open attitude towards other technologies and indications and assess each potential project on its own merits. Identifying projects that could be of interest to CombiGene is a high priority within the company right now.

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Er det mulighet for godis her imorgen??

Forventer vel egentlig ikke så veldig mye nytt, men kanskje litt videre informasjon om tidslinjer og eventuelt om det er noe vi kan forvente oss fremover. Blir også etterhvert itneressant å se hvordan burnraten blir når såpass mye av kostnadene vil dekkes av spark. Ser veldig frem til de oppnår den første milestonen for cg01.

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Fjärde kvartalet oktober – december 2021

• Nettoomsättning: 84 042 (0) TSEK.

• Övriga rörelseintäkter: 1 098 (3 171) TSEK.

• Resultat efter finansiella poster: 57 448 (-10 964) TSEK.

• Resultat per aktie: 2,90 (-1,22) SEK.

Period januari – december 2021

• Nettoomsättning: 84 042 (0) TSEK.

• Övriga rörelseintäkter: 7 478 (12 029) TSEK.

• Resultat efter finansiella poster: 20 965 (-29 551) TSEK.

• Resultat per aktie: 1,21 (-3,31) SEK.

• Likviditet vid periodens utgång: 136 744 (48 895) TSEK.

• Soliditet vid periodens utgång: 95 (89) %.

• Styrelsen föreslår att ingen utdelning lämnas för räkenskapsåret

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Hot felt on dagen!

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Nytt nyhetsbrev fra CombiGene

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Hva er årsaken til det kraftige fallet de siste dagene? Er det bare makro? Det er vel ikke så vanlig at en aksje faller såpass mye uten grunn?

Kraftige rekyler rundt om i biotek nå, men denne virker som er helt glemt. Etter mine beregninger har de omtrent dagens kurs i ren cash i selskapet. Smått utrolig når man tenker på at de har validert teknologien gjennom en big pharma avtale.

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Men når oppvåkningen kommer så blir den råtøff og det kan bli vanskelig for mange å bli med så høyt som den fortjener. Det er mange prosenter å hente her, men når?

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Ser ut som aktøren(e) som har holdt ned nede begynner å gå tom for aksjer.

Noen som kjenner til om det har vært større endringer i aksjonærlisten?