Carnegie tar opp dekning, kursmål 0,25 kr. 150% over dagens kurs
elnomi
22.08.2023 kl 13:55
6706
Riktig, men husk at tekningsrettighene også kan kjøpes/selges hver eneste dag frem til april 2024. Således kan en handle i Tekningsrettighene hver eneste dag (akkurat som i aksjen).
Redigert 22.08.2023 kl 13:56
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Lakshmi
22.08.2023 kl 14:06
6683
Tegningsretter i BergenBio gir investorene en spennende mulighet til å delta i selskapets potensielle vekst og suksess på en gunstig måte. Denne investeringsmuligheten tillater aksjonærene å kjøpe flere aksjer til en rabattert pris i forhold til markedskursen, noe som kan gi en betydelig økonomisk fordel.
En av de mest positive aspektene ved tegningsretter er at de gir eksisterende aksjonærer en sjanse til å øke sin eksponering i selskapet uten å kjøpe aksjer til full markedspris. Dette kan være spesielt gunstig for investorer som allerede har tro på BergenBios potensial og ønsker å øke sin investering uten å måtte investere betydelige ekstra midler.
Tegningsretter kan også tiltrekke seg nye investorer som ønsker å dra nytte av den rabatterte prisen på aksjene. Dette kan føre til økt interesse for selskapet og potensielt øke etterspørselen etter aksjene, noe som kan bidra til å styrke aksjekursen på sikt.
Ved å tilby tegningsretter viser BergenBio en positiv holdning til sine eksisterende aksjonærer og deres ønske om å inkludere dem i selskapets videre vekst og suksess. Dette kan bidra til å bygge tillit og lojalitet blant investorene, samtidig som det gir dem en mulighet til å dra nytte av eventuelle fremtidige oppsidepotensialer.
Samlet sett representerer tegningsretter i BergenBio en positiv investeringsmulighet som kan gi både eksisterende og nye investorer muligheten til å delta i selskapets reise mot suksess og samtidig dra nytte av en rabattert pris på aksjene.
En av de mest positive aspektene ved tegningsretter er at de gir eksisterende aksjonærer en sjanse til å øke sin eksponering i selskapet uten å kjøpe aksjer til full markedspris. Dette kan være spesielt gunstig for investorer som allerede har tro på BergenBios potensial og ønsker å øke sin investering uten å måtte investere betydelige ekstra midler.
Tegningsretter kan også tiltrekke seg nye investorer som ønsker å dra nytte av den rabatterte prisen på aksjene. Dette kan føre til økt interesse for selskapet og potensielt øke etterspørselen etter aksjene, noe som kan bidra til å styrke aksjekursen på sikt.
Ved å tilby tegningsretter viser BergenBio en positiv holdning til sine eksisterende aksjonærer og deres ønske om å inkludere dem i selskapets videre vekst og suksess. Dette kan bidra til å bygge tillit og lojalitet blant investorene, samtidig som det gir dem en mulighet til å dra nytte av eventuelle fremtidige oppsidepotensialer.
Samlet sett representerer tegningsretter i BergenBio en positiv investeringsmulighet som kan gi både eksisterende og nye investorer muligheten til å delta i selskapets reise mot suksess og samtidig dra nytte av en rabattert pris på aksjene.
omans
22.08.2023 kl 14:27
6566
Det kan ha påvirkning ift hvordan man posisjonerer seg, sin horisont og hvordan man snakker. Om en først kom inn etter emisjonsnelding eller under emisjonskurs på 10 øre har man litt annen tilnærming mhp horisont og profitt plan.
Om man først kjøpte på 10-20 kroner, visste man allerede da at TTT for å utvikle medisin som er banebrytende.
Om man først kjøpte på 10-20 kroner, visste man allerede da at TTT for å utvikle medisin som er banebrytende.
Redigert 22.08.2023 kl 14:28
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gen1et
22.08.2023 kl 14:42
6505
BERGEN, Norge, 22. august 2023 – BerGenBio ASA (OSE: BGBIO), et biofarmasøytisk selskap i klinisk fase som utvikler nye, selektive AXL-kinasehemmere for alvorlige udekkede medisinske behov, kunngjorde i dag at ytterligere kliniske data om bemcentinib i kombinasjon med kjemoterapi og med immunterapi ved ikke-småcellet lungekreft (NSCLC) har nylig blitt publisert og akseptert for presentasjon på to kommende internasjonale onkologikonferanser:
Omfattende resultater fra den etterforskerledede studien av bemcentininb + docetaxel hos tidligere behandlede NSCLC-pasienter (Studie BGBIL005) ble publisert i august 2023-utgaven av Lung Cancer. "Fase 1-studie av bemcentinib (BGB324), en førsteklasses, selektiv AXL-hemmer, med docetaxel hos pasienter med tidligere behandlet avansert ikke-småcellet lungekreft." Lung Cancer 182 (2023) Forsøket ble ledet av David Gerber, MD, professor ved UT Southwestern Harold C. Simmons Comprehensive Cancer Center.
Abstraktet "Bemcentinib + Pembrolizumab viser lovende effekt i metastatisk NSCLC som huser mutasjoner assosiert med dårlig prognose: Undersøkende delanalyse fra BGBC008-studien (NCT03184571)" har blitt akseptert for posterpresentasjon på SITC 38th Annual Meeting, som skal holdes 3. november 5, 2023, i San Diego, CA (Abstract #598).
Det abstrakte "Endelige topplinjeresultatene fra BGBC008 fase 2, multisenterstudie av bemcentinib og pembrolizumab (bem+pembro) i 2. linje (2L) avansert ikke-plateepitel (NS) ikke-småcellet lungekreft (NSCLC) (NCT03184571) ” har blitt akseptert for plakatpresentasjon på ESMO-kongressen 2023, som skal holdes 20.–24. oktober 2023, i Madrid, Spania (Abstract #5343)
"Det akkumulerende beviset som støtter den potensielle rollen til bemcentinib i NSCLC stemmer overens med vårt strategiske fokus på denne sykdommen der en stor del av pasientene fortsatt har svært dårlige kliniske resultater fra eksisterende terapier," sa Martin Olin, administrerende direktør i BerGenBio. "Publikasjonen av data i en prestisjetung fagfellevurdert publikasjon og på ESMO og SITC gir oss muligheten til å dele våre data med et bredt publikum av onkologer og sentrale opinionsledere innen NSCLC og farmasøytisk industri."
Omfattende resultater fra den etterforskerledede studien av bemcentininb + docetaxel hos tidligere behandlede NSCLC-pasienter (Studie BGBIL005) ble publisert i august 2023-utgaven av Lung Cancer. "Fase 1-studie av bemcentinib (BGB324), en førsteklasses, selektiv AXL-hemmer, med docetaxel hos pasienter med tidligere behandlet avansert ikke-småcellet lungekreft." Lung Cancer 182 (2023) Forsøket ble ledet av David Gerber, MD, professor ved UT Southwestern Harold C. Simmons Comprehensive Cancer Center.
Abstraktet "Bemcentinib + Pembrolizumab viser lovende effekt i metastatisk NSCLC som huser mutasjoner assosiert med dårlig prognose: Undersøkende delanalyse fra BGBC008-studien (NCT03184571)" har blitt akseptert for posterpresentasjon på SITC 38th Annual Meeting, som skal holdes 3. november 5, 2023, i San Diego, CA (Abstract #598).
Det abstrakte "Endelige topplinjeresultatene fra BGBC008 fase 2, multisenterstudie av bemcentinib og pembrolizumab (bem+pembro) i 2. linje (2L) avansert ikke-plateepitel (NS) ikke-småcellet lungekreft (NSCLC) (NCT03184571) ” har blitt akseptert for plakatpresentasjon på ESMO-kongressen 2023, som skal holdes 20.–24. oktober 2023, i Madrid, Spania (Abstract #5343)
"Det akkumulerende beviset som støtter den potensielle rollen til bemcentinib i NSCLC stemmer overens med vårt strategiske fokus på denne sykdommen der en stor del av pasientene fortsatt har svært dårlige kliniske resultater fra eksisterende terapier," sa Martin Olin, administrerende direktør i BerGenBio. "Publikasjonen av data i en prestisjetung fagfellevurdert publikasjon og på ESMO og SITC gir oss muligheten til å dele våre data med et bredt publikum av onkologer og sentrale opinionsledere innen NSCLC og farmasøytisk industri."
Bullfight
22.08.2023 kl 15:07
6365
Bra omsetning, ser ut som de som akkumulerer forsøker å sperre ned for å laste opp mere (:
Redigert 22.08.2023 kl 15:07
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elnomi
22.08.2023 kl 15:20
6334
Oasen skrev Tro om DNB kommer med nytt kursmål snart..
Eller kanskje Arctic er neste ut mef en anbefaling og nytt kursmål?
Det vil ikke overraske om de følger Carnegie ut!
Det vil ikke overraske om de følger Carnegie ut!
Føre var
23.08.2023 kl 07:07
5362
Ransen
23.08.2023 kl 07:21
5294
Dette er fin lesning. DNB har altså bommet på alle punkt i sin analyse.Flaut.
marked1
23.08.2023 kl 07:22
5314
"Key results include:
· 26 patients with relapsed mesothelioma were enrolled inMiST3and all received at least onedose ofbemcentiniband pembrolizumab.
· The primary endpoint of disease control rate at 12 weeks (DCR12w) was met: 46.2% (90% CI:29.2, 63.4).
· Secondary endpoints included a disease control rate at 24 weeks (DCR24w) of 38.5% (95% CI:20.2, 59.4) and an overall response rate of (ORR) of 15.4% (95%CI: 4.4, 34.9).
· The combination ofbemcentiniband pembrolizumab was generally safe and well -tolerated.
In totality, the Company is very encouraged by the additional clinical data generated with bemcentinib and reported year-to-date 2023. Our current activities are focused on 1L NSCLC STK11m patients; however, we believe these additional datasets may expand the potential beyond STK11m NSCLC patients to other hard-to-treat mutations."
"For the second quarter we are pleased to report the outcomes of our cost -savings efforts and the successful closure of the Rights Issue. In combination this will fund our planned activities into the fourth quarter of 2024 and potentially into the second half of 2025 if all granted warrants at the Rights Issue are exercised."
Dette var meget imponerende og oppløftende resultater fra BGBIO. Med en cashbeholdning ut Q4 2024, evt H2 2025 kan dette bli en eventyrlig reise for aksjonærene. Dette kan bli meget bra, for å si det forsiktig.
· 26 patients with relapsed mesothelioma were enrolled inMiST3and all received at least onedose ofbemcentiniband pembrolizumab.
· The primary endpoint of disease control rate at 12 weeks (DCR12w) was met: 46.2% (90% CI:29.2, 63.4).
· Secondary endpoints included a disease control rate at 24 weeks (DCR24w) of 38.5% (95% CI:20.2, 59.4) and an overall response rate of (ORR) of 15.4% (95%CI: 4.4, 34.9).
· The combination ofbemcentiniband pembrolizumab was generally safe and well -tolerated.
In totality, the Company is very encouraged by the additional clinical data generated with bemcentinib and reported year-to-date 2023. Our current activities are focused on 1L NSCLC STK11m patients; however, we believe these additional datasets may expand the potential beyond STK11m NSCLC patients to other hard-to-treat mutations."
"For the second quarter we are pleased to report the outcomes of our cost -savings efforts and the successful closure of the Rights Issue. In combination this will fund our planned activities into the fourth quarter of 2024 and potentially into the second half of 2025 if all granted warrants at the Rights Issue are exercised."
Dette var meget imponerende og oppløftende resultater fra BGBIO. Med en cashbeholdning ut Q4 2024, evt H2 2025 kan dette bli en eventyrlig reise for aksjonærene. Dette kan bli meget bra, for å si det forsiktig.
Redigert 23.08.2023 kl 08:26
Du må logge inn for å svare
X-43 scramjet
23.08.2023 kl 07:40
5228
På 12.5 øre en gavepakke, alt under 30 øre billig. Kan gå 10 gangeren hvis de lykkes her
Timespa
23.08.2023 kl 07:41
5224
Råsterk rapport. Brukes stadig sterkere ord for å beskrive resultstene og troen på Bemcentinib.
Bighornsteak
23.08.2023 kl 07:46
5194
Er veldig spent fremover, for det nevnes at etter fortrinns emisjonen de utførte tidligere så skal det finansiere de hvertfall til fjerde kvartal 2024. De snakker verdig varmt om forskningen deres der de forteller at de ser en svært oppmuntrede overlevelses fordeler hos pasientene sine. De sier også at de har identifisert en høyere responsrate en forventet noe som de sier peker mot langvarige immunresponsfordeler. Så vi har nokk en spennende tid fremfor oss, og begynner å ser at risikoen minker seg.
Oasen
23.08.2023 kl 07:57
5139
Endelig noen positive resultater og i tillegg redusert utgifter ,vi kan se nye kursmål fremover
X-43 scramjet
23.08.2023 kl 08:04
5093
Aldri før har jeg sett en så lavt priset Biotech aksje. Vi gjør et kupp med å handle på 12 øre. BergenBio kan ha stort potensiale
X-43 scramjet
23.08.2023 kl 08:13
5029
Billyjojimbob skrev Spennende hvor lang tid den bruker til 50 øre 👍
5-6 måneder?
BioBull
23.08.2023 kl 08:14
5020
Føre var skrev https://newsweb.oslobors.no/message/597617
"For the second quarter we are pleased to report the outcomes of our cost
-savings efforts and the successful closure of the Rights Issue. In combination
this will fund our planned activities into the fourth quarter of 2024 and
potentially into the second half of 2025 if all granted warrants at the Rights
Issue are exercised. Our highest priority is to progress the ongoing Phase 1b/2a
clinical trial in first-line STK11m NSCLC patients ("BGBC016") where we are
working towards enrolling the Phase 1b cohorts and initiate the Ph 2a part.
During the second quarter, we obtained a wealth of additional clinical data
which further validate the efficacy and tolerability of our lead compound
bemcentinib. The data provide us with strong confidence in our focused strategy
to study the compound's potential to treat 1L NSCLC patients harboring STK11
mutations. Further, explorative biomarker data from our BGBC008 trial (2L NSCLC)
indicate that bemcentinib in combination with pembrolizumab provides encouraging
survival benefits in patients harboring other hard-to-treat mutations such as
KRAS and KEAP1. During 2023, we have seen increased awareness for the need for
improved treatments for this prevalent patient population with high unmet
needs.", said Martin Olin, Chief Executive Officer of BerGenBio.
Clinical Development
Bemcentinib
BerGenBio's lead compound, bemcentinib, is a potentially first-in-class, oral,
highly selective inhibitor of the receptor tyrosine kinase AXL, which is
expressed and activated in response to oxidative stress, inflammation, hypoxia
and drug treatment, resulting in several deleterious effects in cancer and
severe respiratory infections. Bemcentinib selectively inhibits AXL activation
to prevent the progression of serious diseases through the modulation of
resistance mechanisms and the adaptive immune system.
Bemcentinib is currently being developed in 1L STK11 mutated NSCLC and severe
respiratory infections. Its novel mechanisms of action and primary accumulation
in the lungs uniquely position it to address these severe lung diseases.
Oncology: NSCLC
1L STK11m NSCLC (BGBC016)
We continue to advance our focused strategy through the conduct of BGBC016, a
global, open-label Phase 1b/2a trial designed to determine the safety,
tolerability and efficacy of bemcentinib in combination with standard of care
treatments in untreated advanced/metastatic non-squamous NSCLC patients with
STK11 mutations and no actionable mutations. Sites in the US have been
activated and enrolment is ongoing while expansion into European sites is well
underway, with regulatory approval to proceed received from regulatory
authorities in the US and several European countries.
The Phase 1b portion of the study is evaluating the safety and feasibility of
three different doses of bemcentinib in combination with pembrolizumab and
doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients,
regardless of STK11 status. The Phase 2a expansion will assess the safety and
efficacy of up to two doses of bemcentinib in the same treatment combination in
1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations.
A significant subgroup comprising of up to 20 % (> 30,000 patients in US and
EU5) of 1L non-squamous NSCLC patients harbor STK11 mutations, which are
associated with immunosuppression and poor prognosis with standard 1L NSCLC
treatment. Data suggests that STK11m NSCLC patients almost universally express
AXL in tumors and/or on immune cells, resulting in the development of drug
resistance, immune evasion, and metastases.
The data from the BGBC008 (2L+ NSCLC, bemcentinib in combination with
pembrolizumab) and BGBIL005 (2L+ NSCLC, bemcentinib in combination with
docetaxel) trials provide clinical evidence of the anti-tumor effects of
bemcentinib and its ability to modulate the tumor microenvironment to enhance
the effects of immunotherapy and chemotherapy. We believe that the reversal of
the effects of AXL with bemcentinib holds the promise of providing substantial
survival benefits to NSCLC patients and specifically in patients harboring
STK11m and potentially other hard-to treat mutations such as KRAS and KEAP1.
2L+ NSCLC Trial (BGBC008)
Additional biomarker analyses of the BGBC008 data in the second quarter yielded
promising data which further support the potential for bemcentinib in our on
-going 1L STK11m NSCLC trial and may represent an opportunity to further expand
the patient population that may benefit from the addition of bemcentinib to
their treatment regimens. The Ph2 BGBC008 trial enrolled 90 evaluable 2L+ NSCLC
patients who had received at least one prior line of therapy:chemotherapy,
immunotherapy or the combination.
· An updated analysis of AXL biomarker status indicates that the presence of
AXL expression on either tumor cells and/or immune cells is predictive of
improved survival in patients treated with bemcentinib + pembrolizumab. The vast
majority (88%) of patients met the criteria for AXL presence (AXL positive
patients) and obtained clinically meaningful benefits:
· Median overall survival was highly statistically significant at p=0.001 in
AXL positive vs. AXL negative patients (14.1 mos. vs 6.5 mos).
· Median progression free survival was 6.0 mos. in AXL positive patients vs.
5.8 AXL negative patients
· Analysis of available data for patients treated in a subsequent therapies
(3L+) following treatment with bemcentinib + pembrolizumab in 2L identified a
higher than expected response rate, potentially pointing to long-lasting immune
response benefits.
· Data from the BGBC008 study also indicate that patients with PD-L1 negative
(TPS score <1) benefit from the combination treatment of bemcentinib and
pembrolizumab.
· Currently the PD-L1 negative patient population is not widely treated with
immune checkpoint inhibitors potentially providing an opportunity to expand the
patient population eligible for treatment.
· The combination ofbemcentinib and pembrolizumab appeared to benefit patients
with mutations associated with pooroutcome with available therapies, including
STK11, KRAS, KEAP-1 andSMARCA4 mutations. These mutational patient populations
may represent an incremental opportunity for bemcentinib and will be further
assessed in our on-going BGBC016 study in 1L patients.
Oncology: Relapsed/Refractory AML/MDS
In the second quarter, topline results of the Phase 1b/2a BGBC003 multicenter
open-label studyofbemcentinibas a single agent and in combination with low-dose
cytarabine (LDAC) ordecitabine in patients with acute myeloid leukemia or as a
single agent in patients withmyelodysplastic syndrome.
· Two cohorts of patients in BGBC003 were treated withbemcentinibas a single
agent(monotherapy). In Cohort B1, in patients with Relapsed/Refractory (R/R)
AML, (n=11),bemcentinib provided an ORR of 18.2% and a mOS of 18 months.In
Cohort B4, in patientswith relapsed/high risk MDS,bemcentinibmonotherapy
provided an ORR of 18.8% with a mOSof 9.2months.
· Furthermore,bemcentinibin combination with the chemotherapy LDAC appeared to
provide substantial mOSbenefit to patients with R/R AML (n=27) achieving an ORR
of 18.5% and a mOS of 8months.
Oncology: Mesothelioma
In the second quarter, topline results of the investigator led BGBIL011/MiST3
mesothelioma trial were presentedon June 5, 2023, in an oral presentation at the
2023 American Society of ClinicalOncology (ASCO) meeting in an abstract
titled:Bemcentiniband pembrolizumab in patients withrelapsed mesothelioma:
MiST3, a phaseIIatrial with cellular and molecular correlates of efficacy.
Key results include:
· 26 patients with relapsed mesothelioma were enrolled inMiST3and all received
at least onedose ofbemcentiniband pembrolizumab.
· The primary endpoint of disease control rate at 12 weeks (DCR12w) was met:
46.2% (90% CI:29.2, 63.4).
· Secondary endpoints included a disease control rate at 24 weeks (DCR24w) of
38.5% (95% CI:20.2, 59.4) and an overall response rate of (ORR) of 15.4% (95%
CI: 4.4, 34.9).
· The combination ofbemcentiniband pembrolizumab was generally safe and well
-tolerated.
In totality, the Company is very encouraged by the additional clinical data
generated with bemcentinib and reported year-to-date 2023. Our current
activities are focused on 1L NSCLC STK11m patients; however, we believe these
additional datasets may expand the potential beyond STK11m NSCLC patients to
other hard-to-treat mutations.
Severe Respiratory Infections (SRIs)
The Company believes thatbemcentinibblocks viral entry and replication,
stimulates the innateimmune system, and promotes lung tissue repair positioning
it well for the treatment of severerespiratory infections.
On April 25, 2023, the Company decided to pause the Phase2b trial
evaluatingbemcentinibin hospitalized COVID-19 patients until a potential
accelerationin hospitalizations warrant further evaluation ofbemcentinibin this
population.
Bemcentinibis currently being evaluated in preclinical studies for SRIs causing
Acute RespiratoryDistress Syndrome (ARDS) and initial results are expected
during 2023.
Corporate Activities
Rights Offering
On June 13, 2023, the Company completed a rights issue raising gross proceeds
ofNOK 250m.The proceeds from this offering including any additional proceeds
from the exercise of warrants will be dedicated to the conduct of BGBC016 in 1L
STK11mNSCLC patients, preclinical studies in severe respiratory infections and
forgeneral corporatepurposes.
Focused organizational structure aligned with strategy
The Company has taken measures to further reduce its operational costs
includinga significant reduction in workforce and total compensation to the
executive management andthe board of directors. This includes a transition of
the CSO to a part-time consultancy position. These prudent actions will reduce
total operating expenses by at least30% compared to historic operational
expenses when fully implemented.
-savings efforts and the successful closure of the Rights Issue. In combination
this will fund our planned activities into the fourth quarter of 2024 and
potentially into the second half of 2025 if all granted warrants at the Rights
Issue are exercised. Our highest priority is to progress the ongoing Phase 1b/2a
clinical trial in first-line STK11m NSCLC patients ("BGBC016") where we are
working towards enrolling the Phase 1b cohorts and initiate the Ph 2a part.
During the second quarter, we obtained a wealth of additional clinical data
which further validate the efficacy and tolerability of our lead compound
bemcentinib. The data provide us with strong confidence in our focused strategy
to study the compound's potential to treat 1L NSCLC patients harboring STK11
mutations. Further, explorative biomarker data from our BGBC008 trial (2L NSCLC)
indicate that bemcentinib in combination with pembrolizumab provides encouraging
survival benefits in patients harboring other hard-to-treat mutations such as
KRAS and KEAP1. During 2023, we have seen increased awareness for the need for
improved treatments for this prevalent patient population with high unmet
needs.", said Martin Olin, Chief Executive Officer of BerGenBio.
Clinical Development
Bemcentinib
BerGenBio's lead compound, bemcentinib, is a potentially first-in-class, oral,
highly selective inhibitor of the receptor tyrosine kinase AXL, which is
expressed and activated in response to oxidative stress, inflammation, hypoxia
and drug treatment, resulting in several deleterious effects in cancer and
severe respiratory infections. Bemcentinib selectively inhibits AXL activation
to prevent the progression of serious diseases through the modulation of
resistance mechanisms and the adaptive immune system.
Bemcentinib is currently being developed in 1L STK11 mutated NSCLC and severe
respiratory infections. Its novel mechanisms of action and primary accumulation
in the lungs uniquely position it to address these severe lung diseases.
Oncology: NSCLC
1L STK11m NSCLC (BGBC016)
We continue to advance our focused strategy through the conduct of BGBC016, a
global, open-label Phase 1b/2a trial designed to determine the safety,
tolerability and efficacy of bemcentinib in combination with standard of care
treatments in untreated advanced/metastatic non-squamous NSCLC patients with
STK11 mutations and no actionable mutations. Sites in the US have been
activated and enrolment is ongoing while expansion into European sites is well
underway, with regulatory approval to proceed received from regulatory
authorities in the US and several European countries.
The Phase 1b portion of the study is evaluating the safety and feasibility of
three different doses of bemcentinib in combination with pembrolizumab and
doublet chemotherapy in 1L advanced/metastatic non-squamous NSCLC patients,
regardless of STK11 status. The Phase 2a expansion will assess the safety and
efficacy of up to two doses of bemcentinib in the same treatment combination in
1L advanced/metastatic non-squamous NSCLC patients with STK11 mutations.
A significant subgroup comprising of up to 20 % (> 30,000 patients in US and
EU5) of 1L non-squamous NSCLC patients harbor STK11 mutations, which are
associated with immunosuppression and poor prognosis with standard 1L NSCLC
treatment. Data suggests that STK11m NSCLC patients almost universally express
AXL in tumors and/or on immune cells, resulting in the development of drug
resistance, immune evasion, and metastases.
The data from the BGBC008 (2L+ NSCLC, bemcentinib in combination with
pembrolizumab) and BGBIL005 (2L+ NSCLC, bemcentinib in combination with
docetaxel) trials provide clinical evidence of the anti-tumor effects of
bemcentinib and its ability to modulate the tumor microenvironment to enhance
the effects of immunotherapy and chemotherapy. We believe that the reversal of
the effects of AXL with bemcentinib holds the promise of providing substantial
survival benefits to NSCLC patients and specifically in patients harboring
STK11m and potentially other hard-to treat mutations such as KRAS and KEAP1.
2L+ NSCLC Trial (BGBC008)
Additional biomarker analyses of the BGBC008 data in the second quarter yielded
promising data which further support the potential for bemcentinib in our on
-going 1L STK11m NSCLC trial and may represent an opportunity to further expand
the patient population that may benefit from the addition of bemcentinib to
their treatment regimens. The Ph2 BGBC008 trial enrolled 90 evaluable 2L+ NSCLC
patients who had received at least one prior line of therapy:chemotherapy,
immunotherapy or the combination.
· An updated analysis of AXL biomarker status indicates that the presence of
AXL expression on either tumor cells and/or immune cells is predictive of
improved survival in patients treated with bemcentinib + pembrolizumab. The vast
majority (88%) of patients met the criteria for AXL presence (AXL positive
patients) and obtained clinically meaningful benefits:
· Median overall survival was highly statistically significant at p=0.001 in
AXL positive vs. AXL negative patients (14.1 mos. vs 6.5 mos).
· Median progression free survival was 6.0 mos. in AXL positive patients vs.
5.8 AXL negative patients
· Analysis of available data for patients treated in a subsequent therapies
(3L+) following treatment with bemcentinib + pembrolizumab in 2L identified a
higher than expected response rate, potentially pointing to long-lasting immune
response benefits.
· Data from the BGBC008 study also indicate that patients with PD-L1 negative
(TPS score <1) benefit from the combination treatment of bemcentinib and
pembrolizumab.
· Currently the PD-L1 negative patient population is not widely treated with
immune checkpoint inhibitors potentially providing an opportunity to expand the
patient population eligible for treatment.
· The combination ofbemcentinib and pembrolizumab appeared to benefit patients
with mutations associated with pooroutcome with available therapies, including
STK11, KRAS, KEAP-1 andSMARCA4 mutations. These mutational patient populations
may represent an incremental opportunity for bemcentinib and will be further
assessed in our on-going BGBC016 study in 1L patients.
Oncology: Relapsed/Refractory AML/MDS
In the second quarter, topline results of the Phase 1b/2a BGBC003 multicenter
open-label studyofbemcentinibas a single agent and in combination with low-dose
cytarabine (LDAC) ordecitabine in patients with acute myeloid leukemia or as a
single agent in patients withmyelodysplastic syndrome.
· Two cohorts of patients in BGBC003 were treated withbemcentinibas a single
agent(monotherapy). In Cohort B1, in patients with Relapsed/Refractory (R/R)
AML, (n=11),bemcentinib provided an ORR of 18.2% and a mOS of 18 months.In
Cohort B4, in patientswith relapsed/high risk MDS,bemcentinibmonotherapy
provided an ORR of 18.8% with a mOSof 9.2months.
· Furthermore,bemcentinibin combination with the chemotherapy LDAC appeared to
provide substantial mOSbenefit to patients with R/R AML (n=27) achieving an ORR
of 18.5% and a mOS of 8months.
Oncology: Mesothelioma
In the second quarter, topline results of the investigator led BGBIL011/MiST3
mesothelioma trial were presentedon June 5, 2023, in an oral presentation at the
2023 American Society of ClinicalOncology (ASCO) meeting in an abstract
titled:Bemcentiniband pembrolizumab in patients withrelapsed mesothelioma:
MiST3, a phaseIIatrial with cellular and molecular correlates of efficacy.
Key results include:
· 26 patients with relapsed mesothelioma were enrolled inMiST3and all received
at least onedose ofbemcentiniband pembrolizumab.
· The primary endpoint of disease control rate at 12 weeks (DCR12w) was met:
46.2% (90% CI:29.2, 63.4).
· Secondary endpoints included a disease control rate at 24 weeks (DCR24w) of
38.5% (95% CI:20.2, 59.4) and an overall response rate of (ORR) of 15.4% (95%
CI: 4.4, 34.9).
· The combination ofbemcentiniband pembrolizumab was generally safe and well
-tolerated.
In totality, the Company is very encouraged by the additional clinical data
generated with bemcentinib and reported year-to-date 2023. Our current
activities are focused on 1L NSCLC STK11m patients; however, we believe these
additional datasets may expand the potential beyond STK11m NSCLC patients to
other hard-to-treat mutations.
Severe Respiratory Infections (SRIs)
The Company believes thatbemcentinibblocks viral entry and replication,
stimulates the innateimmune system, and promotes lung tissue repair positioning
it well for the treatment of severerespiratory infections.
On April 25, 2023, the Company decided to pause the Phase2b trial
evaluatingbemcentinibin hospitalized COVID-19 patients until a potential
accelerationin hospitalizations warrant further evaluation ofbemcentinibin this
population.
Bemcentinibis currently being evaluated in preclinical studies for SRIs causing
Acute RespiratoryDistress Syndrome (ARDS) and initial results are expected
during 2023.
Corporate Activities
Rights Offering
On June 13, 2023, the Company completed a rights issue raising gross proceeds
ofNOK 250m.The proceeds from this offering including any additional proceeds
from the exercise of warrants will be dedicated to the conduct of BGBC016 in 1L
STK11mNSCLC patients, preclinical studies in severe respiratory infections and
forgeneral corporatepurposes.
Focused organizational structure aligned with strategy
The Company has taken measures to further reduce its operational costs
includinga significant reduction in workforce and total compensation to the
executive management andthe board of directors. This includes a transition of
the CSO to a part-time consultancy position. These prudent actions will reduce
total operating expenses by at least30% compared to historic operational
expenses when fully implemented.
elnomi
23.08.2023 kl 08:16
5005
Dette var meget solid og viser jo at Carniegie sin analyser med kursmål 25 øre gir et solid fundament.
Dataene er meget oppløftene, kursen er priset som en opsjon på noe suksess med 12,5 øre. Nok penger minst ut 2024 eller ut første halvår 2025. Potensiell oppkjøpskandidat m.m. Alt dette gjør at kursen har potensial til å løfte seg betydelig fremover til 20-30 øre. Vil ikke overraske meg om kursen går godt opp videre i dag og i ukene fremover.
Det blir spennende å høre hva selskapet selv foreteller i dag kl. 10.45
Dataene er meget oppløftene, kursen er priset som en opsjon på noe suksess med 12,5 øre. Nok penger minst ut 2024 eller ut første halvår 2025. Potensiell oppkjøpskandidat m.m. Alt dette gjør at kursen har potensial til å løfte seg betydelig fremover til 20-30 øre. Vil ikke overraske meg om kursen går godt opp videre i dag og i ukene fremover.
Det blir spennende å høre hva selskapet selv foreteller i dag kl. 10.45
Føre var
23.08.2023 kl 08:21
4983
Jeg likte denne setningen godt:
«Our current
activities are focused on 1L NSCLC STK11m patients; however, we believe these
additional datasets may expand the potential beyond STK11m NSCLC patients to
other hard-to-treat mutations.»
«Our current
activities are focused on 1L NSCLC STK11m patients; however, we believe these
additional datasets may expand the potential beyond STK11m NSCLC patients to
other hard-to-treat mutations.»
ctrlaltdel
23.08.2023 kl 08:45
4823
Og hva er så bra med: we believe these additional datasets may expand .
Det er ikke mulig å skrive det mer utydelig:De TROR at datasettene KANSKJE øker potensialet!!!
Det er ikke mulig å skrive det mer utydelig:De TROR at datasettene KANSKJE øker potensialet!!!
elnomi
23.08.2023 kl 08:53
4760
Det ser ut som noen har lagt ut åpent en post på 5 millioner aksjer på 13 øre ved åpning for å "holde kursen nede". Skal bli spennende å se hvor raskt den posten blir slukt opp av kjøpere. Tror det blir en ny meget godt dag i BGBIO. Risk/reward har ikke vært bedre på 12,5 øre.
StockWizard
23.08.2023 kl 08:56
4746
X-43 scramjet skrev 5-6 måneder?
Ingen tvil om kursutvikling mot sept. for å motivere TR holdere å signere tegne sine rettigheter på 10-13 øre!
Broker74
23.08.2023 kl 09:08
4660
åpningen er et spill for galleriet, sikker på at dette blir siste dagen for mulighet å handle under 0,13
marked1
23.08.2023 kl 09:13
4678
Absolutt. Noen med noen millioner aksjer for mye la press på aksjen fra start. Tenker at aksjen skal solid i pluss utover dagen, og fortsette oppturen fra i går.
elnomi
23.08.2023 kl 09:14
4679
Her er det et fint lite spill for galleriet, men etter presentasjonen kl. 10.45 er det ikke sikkert om en klarer å holde kursen ned under 0,13.
Mitt tips er at kursen slutter godt i pluss mellom 0,13-0,14. Dagens Q3 info var meget positiv og indikerer at denne høsten kan bli en meget lukrativ reise for alle med aksjer og tekningsrettigheter. Selv kjøpte jeg aksjer i dag på lave 0,11 tallet (har fra tidligere lastet opp i tekningsrettighetene)
Mitt tips er at kursen slutter godt i pluss mellom 0,13-0,14. Dagens Q3 info var meget positiv og indikerer at denne høsten kan bli en meget lukrativ reise for alle med aksjer og tekningsrettigheter. Selv kjøpte jeg aksjer i dag på lave 0,11 tallet (har fra tidligere lastet opp i tekningsrettighetene)
Broker74
23.08.2023 kl 09:18
4647
blir spennende å høre fra selskapet senere i dag. Er det 6mnd historikken vi nå kan se til for å se kursutviklingen fremover :-)
elnomi
23.08.2023 kl 09:26
4701
Ligger over 6 millioner aksjer åpent på 13 øre (det er nok for å hindre brå kursoppgang og at noen kan kjøpe med skulte ordre i det stille under 13 øre , ellers ville det nok lagt med skjule ordre?). Blir spennende å se om/når "sperren" på 13 øre ryker i dag?
ctrlaltdel
23.08.2023 kl 09:33
4667
I dag er 43 millioner aksjer omsatt på 1/2 timen. I går ble 220 millioner aksjer omsatt. Hvem er det som hamstrer ?
marked1
23.08.2023 kl 09:47
4570
BGBIO ble handlet over 30 - 40 kroner (!) for kun et par tre år siden. I tillegg til nye aksjonærer kan det også være endel gamle aksjonærer som ser at skuta er i ferd med å snu og som nå kjøper og får lavere snitt.
Redigert 23.08.2023 kl 09:49
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MaxMekker
23.08.2023 kl 10:01
4513
Er det godt eller dårlig tegn at det ikke er solgt noen TR i dag ?
omans
23.08.2023 kl 10:09
4460
De kan også mislykkes. Har vært nok av biotek som har oppnådd presentasjoner fra studier, men ikke fått noe siccess videre.
Redigert 23.08.2023 kl 10:09
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Broker74
23.08.2023 kl 10:17
4441
et vet alle som handler i tech og bio aksjer, det prises på forventninger og måles underveis av fremgangen på utviklingen. Denne prises nå ekstremt lavt nå, vel får vente til vi har hørt hva selskapet selv sier, men tror mere på Carnegie sitt kursmål innfries meget snart.