Larkberget AB (LARK)🇸🇪 (Tidligere CombiGene AB)

[Rahl]

CombiGene receives a second payment of EUR 1.21 million from Horizon 2020

Nov 18, 2019

May 15, 2018, CombiGene announced that Horizon 2020, the EU framework program for research and development, will invest EUR 3.36 million in CombiGene’s ongoing development and commercialization of the company’s gene therapy project focusing on hard-to-treat epilepsy. The upfront payment amounted to EUR 1.51 million. The second payment amounts to EUR 1.21 million and has now been payed after a careful examination of the project by EU and their external reviewer.

“The payment from Horizon 2020 is a confirmation of the progress that has been made within the CG01 project, not least the work we are doing together with CGT Catapult to develop a commercially viable production method”, says Karin Agerman, Karin Agerman, Chief Research and Development Officer at CombiGene. “In addition to getting our report approved and the money paid to our account, we have also received positive feedback and valuable recommendations from Horizon 2020’s external reviewer. That our epilepsy project is one of the projects that Horizon 2020 has chosen to invest in means a lot for CombiGene. In addition to the capital that is provided into the project, it is also a significant seal of excellence of our development work and commercial potential.”

https://combigene.com/en/news-and-reports/combigene-receives-a-second-payment-of-eur-1-21-million-from-horizon-2020/

[Realize_1]

Skjer her?

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Lite/ingen interesse. Må være ekstremt tålmodig med Combigene

[laplagam]

Veldig fin melding og Selskapet trenger en skikkelig markedsboost og få has på noen storfisker som investorer.

[laplagam]

Ny analyse ute for CombiGene (link nederst i innlegg). Nye oppdaterte kursmål er satt inn. Base case er satt ned fra 2.2 til 1.8 pga. aksjeutvanning som følge av oppkjøpet av Panion.

Bear: 1.1
Base: 1.8
Bull: 3.7

Verdivurdering i forhold til selskapet og assets:

Partiell lipodystrofi er ikke tatt med å estimatene pga. at de er i tidlig fase.
Kontantbeholdning er antatt å vare frem til H2 2020.
Avtale og utvikling i forhold til den nye indikasjonen partiell lipodystrofi er pga tidlig fase ikke lagt inn med verdi i analysen. De anser likevel for at dette har et potensialet og vil eventuelt få dette med på senere tidspunkt.

Ellers også en fin vurdering i forhold til selskapet og risiko er tatt med.

For å dra inn min egen personlige vurdering i forhold til risiko her så mener jeg at i forhold til investeringscaset så er det finansiering som blir den største utfordringen.
En av de store fordelene CombiGene har i forhold til andre genterapi selskaper i pre-klinisk fase er at de faktisk har tested medikamentet sitt på menneskelig hjernevev og sett at den gode effekten de har fått pre-klinisk, har de fått testet i menneskelig vev og sett at de får den responsen de ønsker. Dette vil jeg påstå gir en liten ekstra edge i forhold til å vurdere sannsynlighet for å lykkes. Her er det derimot lang vei å gå, men utrolig spennende prosjekt. Gleder meg til fortsettelsen.

combigene_analys_191128.pdf

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Gode nyheter for Combigene!

PCI Biotech - Småprat 2019 (PCIB)

“Gene therapy returns to the center stage of medicine to treat patients with diseases that are unable to be cured with the conventional therapeutic strategies. This development is due to various reasons, including vector development and significant achievement in next-generation sequencing. Among the various methodologies of gene therapy, nucleic acid-based therapy has been considered to be promising in various diseases. The development of delivery methods to target cells in vivo, however, remai…

John Carroll (JohnCendpts)

[laplagam]

Mer omtale fra Combigene

CombiGenes förvärv och exit-ambitioner - BioStock

[laplagam]

Ny artikkel ute i Nature rundt forskningen gjort av en av forskjerne til CombiGene. Dette er teknologien de bygger på i sin kommende behandling for Epilepsi. Det er jo rimelig høyinteressant at et selskap i pre-klinisk med proof of concep kan vise at de skaper den reaksjonen de ønsker også i mennekslig hjernevev i forhold til å kunne behandle og muligens kurere Epilepsi ligger for øyeblikket på 70 MSEK mcap. Hvis dette selskapet først får vind i seilene så kan det fly høyt.

Study in human brain tissue shows that NPY can suppress epileptic activity via Y2-receptor activation

Professor Merab Kokaia, one of CombiGene’s scientific founders, has conducted an important study concerning the suppression of epileptic activity via activation of the brain’s Y2 receptors. The study was conducted in human, pharmacoresistant epileptic brain tissue that had been donated in connection with a surgical procedure carried out to inhibit epileptic seizures.

The study clearly demonstrates that, by activating the brain’s Y2 receptors, epileptic activity in pharmacoresistant epileptic brain tissue can be suppressed with NPY. NPY’s mechanism of action is exactly what CombiGene intends to achieve with the candidate drug, CG01. The results therefore provide a very promising basis for testing the treatment in clinical studies.

The results from the study is available here:
https://www.nature.com/articles/s41598-019-56062-1#citeas

Nedenfor er en direkte bedre direkte link direkte til studien.
https://www.nature.com/articles/s41598-019-56062-1

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Meget interessant artikkel i Nature rett før jul (ref posten til @laplagam rett over). Blir spennende å følge Combigene i 2020 og fremover nå som genterapi virkelig begynner å skyte fart.

The new lipodystrophy project secures CombiGene’s position as the leading Nordic gene therapy company

https://combigene.com/en/business-concept-and-vision/

The promise of huge returns on gene and cell therapies will likely drive acquisitions in 2020, Choy predicted. “These treatments are so transformative for patients, and as the clinical proof of effectiveness continues to grow, you’re going to see a lot more deal-making in this area,” he said.

Buyers will likely show a willingness to invest in early-stage gene and cell therapies, especially if they come with technology platforms that allow for the development of many follow-up products, Choy added. “For these types of therapies, the lifecycles will be much shorter than they are for traditional pharmaceuticals, particularly for rare diseases,” he said. “If you administer a one-time therapy, that revenue peaks quite quickly and then drops off. So to have a sustainable revenue from a gene therapy business, you need to replace that, which requires managing a pipeline.”

Pharma's gene and cell therapy ambitions will kick into high gear in...

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Cell- och genterapiområdet behåller momentum - BioStock

[Rahl]

Combigene resolves on a new issue of shares raising MSEK 32.5 covered to 80 percent by subscription and guarantee commitments

The Board of Directors in Combigene AB (“Combigene” or the “Company”), reg. no. 556403-3818, has today, the 18 February 2020, resolved on a new issue of shares of not more than MSEK 32.5 with pre-emption rights for the Company’s shareholders (the “Rights Issue”). The Rights Issue is carried out in accordance with the authorization to the Board of Directors from the Annual General Meeting in Combigene on 16 May 2019. Subscription and guarantee commitments amounting to MSEK 26, equal to 80 percent of the Rights Issue, have been obtained from external guarantors and the Company’s Board of Directors.

Terms for the Rights Issue

Two (2) shares owned on the record date gives the right to subscribe for one (1) unit. Each unit contains two (2) new shares, one (1) warrant of series TO1 and one (1) warrant of series TO2. The subscription price per unit is SEK 1.00, equal to SEK 0.50 per share. The warrants are issued for free. TO1 expires in August 2020, and TO2 expires in November 2020. The subscription price will be decided with regard to the volume weighted average price of the 10 trading days before exercise with a discount of 30 percent. However, the minimum subscription price to subscribe for shares with TO1 will be SEK 0.4 and the maximum will be 0.6. The minimum subscription price to subscribe for shares with TO2 will be SEK 0.5 and the maximum will be 0.7 per share

There are presently 65,053,647 shares outstanding in the Company. The Rights Issue entails not more than 32,526,823 units being issued with pre-emptive rights for the Company’s shareholders. This means that not more than 65,053,646 new shares and not more than 65,053,646 new warrants may be issued. Assuming full subscription of the Rights Issue, the Company will receive not more than MSEK 32.5 before issue costs, which are estimated to MSEK 3.7. Assuming that all warrants are used to subscribe for new shares, additionally not more than 65,053,646 shares will be issued and the Company will thus receive an additional amount of not more than MSEK 42.3.

The record date for the right to participate in the Rights Issue is 18 March 2020.

The last day of trading including unit rights is 16 March 2020. The first day of trading excluding unit rights is 17 March 2020.

The subscription period runs from 20 March – 3 April 2020. Trading with unit rights takes place between 20 March – 1 April 2020.

The prospectus regarding the Rights Issue with full terms is estimated to be published on
16 March 2020.

The Rights Issue contains an oversubscription option of not more than 4.95 million shares directed to the guarantors that may choose to set off a part against the agreed guarantee commission.

The Company’s main focus is to further advance the main project CG01, which focuses on focal epilepsy, on its path towards clinical trials. To pursue the project further this new issue of shares needs to be carried out.

Subscription and guarantee commitments

80 percent of the Rights Issue is covered by external guarantee commitments, partly including the subscription commitments by the Board of Directors.

Partner Fondkommission is the financial advisor in connection with the Rights Issue.

Comment by Jan Nilsson, CEO

“With this new issue of shares Combigene will receive resources to further conduct the epilepsy project CG01 with full force. The results from the animal trials show a very promising potential for all those epilepsy patients that do not have any medical treatment alternatives. The market potential for our chosen indication is SEK 4-10 billion per year even with careful assumptions. We welcome shareholders to take part of this exciting journey.

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Har jo bare ventet på dette selv om det kanskje kom litt tidligere enn jeg hadde trodd med tanke på at de har en del Horizon 2020 penger ennå. Men var kanskje fornuftig å gjøre det nå ettersom det sannsynligvis er fåvkursløftende nyheter å vente i 2020.

Jeg er klar for å fylle på her

Safety først nå og så klinisk. Når vi kommer dit så tror jeg vi ser en helt annen verdsetting enn det vi har i dag.

[zappa66]

Voldsom utvanning, 200% flere aksjer om det blir fulltegnet og alle TO benyttes

[laplagam]

Blir vel strengt tatt kun 100% utvanning. 2 aksjer = 1 unit = 2 aksjer (de har det med å gjøre ting komplisert )

Det jeg liker med emisjonen er at innbetalingen og bestemmelsen av kursen skjer først i August og September. Det gjør strengt tatt at dersom kursen begynner å gå oppover i forkant på nyheter så kan det bli rift om aksjene for tilgang til units. Det kan dytte både kurs opp og gi verdi til eksisterende aksjonærer som får unites/tegningsretter. I tillegg er emisjonen garantert 80% så finansieringen i forhold til emisjonen kommer uansett på plass. Dette kjøper selskapet ganske godt med tid fremover på vei mot å nå klinisk fase.

På kort sikt så har dette slått ut som det ofte gjør med emisjoner, men liker at vi allerede nå har sikret finansieringen som ikke skal skje før på høsten. Da kan en fokusere på driften fremover mot klinisk fase. Synes dette er veldig bra. Får heller tåle at markedet gav kursen en liten trøkk her. Tror det fort kan snu ganske så bra utover høsten. Håper ihvertfall det

[zappa66]

Blir vel strengt tatt kun 100% utvanning. 2 aksjer = 1 unit = 2 aksjer (de har det med å gjøre ting komplisert )

Du må huske på TO-ene også

[laplagam]

Du må huske på TO-ene også

TO1 og TO2 er fra det jeg kan se de 2 aksjene en får fra uniten. Det står også at det finnes 65,053,647 aksjer og at det vil med fulltegning være “no more than 65,053,646 shares”. Jeg tror jeg fortsatt det jeg skriver er riktig. De har hatt en emisjonen tidligere som var ganske lik. Uthevet i teksten nedenfor. Jeg tror jeg har rett, men aldri godt å vite når det blir såpass detaljert

There are presently 65,053,647 shares outstanding in the Company. The Rights Issue entails not more than 32,526,823 units being issued with pre-emptive rights for the Company’s shareholders. This means that not more than 65,053,646 new shares and not more than 65,053,646 new warrants may be issued. Assuming full subscription of the Rights Issue, the Company will receive not more than MSEK 32.5 before issue costs, which are estimated to MSEK 3.7. Assuming that all warrants are used to subscribe for new shares, additionally not more than 65,053,646 shares will be issued and the Company will thus receive an additional amount of not more than MSEK 42.3.

[zappa66]

Ikke for å gjøre dette til en stor sak, men det er kanskje bevist fra selskapet at de gjør meldingen uklar.
Det skal tildeles 32 526 823 units. Hver unit inneholder 2 aksjer, 1 TO1 og en TO. Dette vil da gi 65 053 647 nye aksjer, 32 526 823 TO1 og 32 526 823 TO2

There are presently 65,053,647 shares outstanding in the Company. The Rights Issue entails not more than 32,526,823 units being issued with pre-emptive rights for the Company’s shareholders. This means that not more than 65,053,646 new shares and not more than 65,053,646 new warrants may be issued.

[laplagam]

Ja, men om du har 1000 aksjer så får du kun 500 units som gir 1000 aksjer Så blir 100%.

Årsaken til oppsettet er at TO1 og TO2 har forskjellige kriterier, og derfor må du bruke denne inndelingen. Om en ikke har vært borti dette tidligere så er det vanskelig å komplisert å forstå. Brukte mye tid på dette forrige gang de hadde emisjon.

Edit: var kanskje det du mente i forrige post. Kanskje jeg misforstod.

[laplagam]

Presentasjon på Aktiedagen i Stockholm med CombiGene på mandag. Linka direkte til CG sin presentasjon.

[Rahl]

Emisjonen er i gang. Passet bra med disse nyhetene da:

CombiGene has concluded the planned pharmacokinetic study in the CG01 epilepsy project with promising results.

CombiGene recently concluded the preclinical pharmacokinetic study in the CG01 project. The outcome of the study is very promising and means that CombiGene now has the answers to key questions with respect to the long-term expression of NPY and Y2.

Successful pharmacokinetic study confirms that CG01 creates long-term expression of NPY and Y2
CombiGene’s candidate drug, CG01, is being developed for treatment of patients with drug-resistant focal epilepsy. The aim is to enable a very long-term therapeutic effect through a one-time administration. To determine how the body takes up a drug and how lasting the effect is, so-called pharmacokinetic studies are conducted. CombiGene recently concluded a study of this kind, the results of which are extremely encouraging.

The concluded study clearly shows that the expression (occurrence) of neuropeptide Y (NPY) and its receptor, Y2, increases markedly after only one week following administration of CG01, and then continues to increase during the following two weeks, reaching a plateau after three weeks. It is particularly pleasing to note that the level achieved after three weeks remained stable throughout the duration of the study, i.e., six months.
“One question that often arises in our discussions with physicians is just how long we can expect to see an effect in humans after an injection and whether several injections will be necessary to maintain the effect. This study shows that the expression or occurrence of NPY/Y2 persists over a long period. This provides further evidence that a single injection should have an effect that lasts for many years. A rule of thumb is that six months in the experimental model we have used for our pharmacokinetic study corresponds to 15 years in humans.

The results from the pharmacokinetic study are extremely encouraging,” says a very satisfied Annika Ericsson, Senior Project Manager, CombiGene. Findings from the pharmacokinetic study are gratifying in other respects as well. Understanding how CG01 acts in the brain is also an important piece of knowledge that will aid planning of the coming safety studies (toxicology and biodistribution) in an optimal way. Knowledge gained from the pharmacokinetic study will also constitute a central component in the design of the first study in humans.