Her er min oppstilling på cash og cash burn.
Oppsumering:
Utviklingen i cash:
Og historisk burnrate:
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I mitt regnestykke holder pengene til PCIB til ut q4 2022, med da evnt emi i q3 2022. Dette med en snitt cashburn på 24.3 mill NOK hvert kvartal. Dette skal holde til guidet interimavlesning i q2 2022.
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Absolutt kjekt å se 
Samtidig er vel faktisk cash før emi H219 vs avg cash før emi i nano ca 100 mill mindre, så hvor mye man kan lese ut av dette er jo ikke så enkelt…
Nei, det sier jo ingenting om fremtiden, men en pekepinn kanskje. Feks overraskende hvor lenge pcib tør å vente før de henter penger.
PCIB er vel den som ikke trenger penger på lenge.
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Ser ut til at vi avslutter året meget sterkt!
Siste 3 mnd har vært som en drøm…måtte det fortsette i 2020!
Godt Nyttår godtfolk!
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Er det noen grunn til at du ikke har investert i Ultimovacs? Hadde vært interessant å høre om du har noen synspunkter.
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Dette er ekstremt positivt for alle biotek selskapene som er potensielle oppkjøpskandidater!
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Kjøper ikke argumentene hans, men enig i at vi er på ei mot en ytterligere svekkelse. De store pengene går mot de store valuta (minimere valuta risiko). Dette er og kommer ikke til å bli et NOK fenomen.
Men ja. Pris i NOK vil bli skyhøye ved eventuelt oppkjøp grunnet valutakursen 
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Her er litt mer å følge med på vedr amerikanske biotekaksjer:
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Fylte faktisk på med litt Ultimovacs i går. Ville ikke kjøpe før biotech-sektoren på Oslobørs viste mer positive tendenser. Har nå kjøpt en liten andel. Likte godt den nye studien de sksl kjøre i samarbeid mef Oslo Universitetssykehus. Den burde gi klare signaler på evt. effekt av vaksinen.
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Nja, det er vel et tveegget sverd sålenge de er prekommersielle. Utgifter i dollar og euro og emisjoner i norske kroner gjør at kronene flyr raskere ut
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Tenkte ikke over det.
Men feks Targovax, der står lønnskostnader for ca halvparten av kostnadene. Og mye av det er i kroner.
Kun ved en eventuelt emisjon det vil bli et valuta spørsmål… Dagens penger som selskaper har på bok ligger nok allerede i Dollar og Euro og strategisk fordelt for å minimere valuta risiko.
Dess lavere NOK blir dess mer interessant (billigere) blir selskapene for utenlandsk kapital. Sann sett kan man motargumenter denne valuta frykten med at aksjekursen KAN bli mye høyere en ellers ville ha blitt.
Enig. Så når BP ser på sammenlignbare priser for andre avtaler eller oppkjøp av selskaper, ser de selvsagt på prisen i USD eller EUR, ikke NOK.
Noe som for eksempel ville gitt en mye høyere aksjekurs i NOK for Algeta dersom det salget hadde skjedd i dag. Fordi USD har styrket seg markant mot NOK siden den gang.
Så i avtale- og oppkjøpssammenheng er det selvsagt meget positivt med en svak krone.
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Takk for 2019, og godt nytt år til alle Biotekere og alle andre her inne! 
Vi får håpe at 2020 blir like spennende som NANO var usexy i 2019. Eller like spenstig som PCIB sin aksjekurs på slutten nå.
Måtte oppgangen i 4. kvartal 2019 fortone seg som mild bris retrospekt 2020!
Til slutt et spesialønske - det ultimate - for 2020 , og det er at vår eminente @pdx omdøper forumet til BIOTekinvestor 
en gang i blant, enten når euforien på de ulike trådene tilsier det, eller dersom nok en ørkenvandring krever en felles biotekoppmuntring 
Det ville vært prikken over alle i-ene i mitt vokabular!
Yipikaye! Snakkes neste år!
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En svekket kronekurs er positivt for eksportselskapene som har inntekter i euro/dollar og utgifter i NOK. Effekten er positiv for Photocure, selv om de også har noe utgifter i dollar.
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Interessant å følge #biopick2020 på Twitter.
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På årets liste over FDA approvals er det 48 godkjente legemidler, hvorav 9 for onkologi. Dvs det er 49 godkjenninger, hvorav 10 for onkologi, men siste godkjennelser av AstraZenecas Lynparza for visse med pancreatic cancer er ikke oppdatert på denne linken. Forklaringen er nok at den ikke er oppdatert siden Lynparza-godkjennelsen kom 30. desember.
Jeg har laget en oversikt på de 10 onkologiske godkjennelsene, siden det er det som er relevant for de fleste biotek-investorene på OSE, ut fra linken pluss det jeg fant på nett om Lynparza-godkjennelsen.
12 April 2019
FDA approves first targeted therapy for metastatic bladder cancer
The efficacy of Balversa was studied in a clinical trial that included 87 patients with locally advanced or metastatic bladder cancer, with FGFR3 or FGFR2 genetic alterations, that had progressed following treatment with chemotherapy. The overall response rate in these patients was 32.2%, with 2.3% having a complete response and almost 30% having a partial response. The response lasted for an average of approximately five-and-a-half months. About a quarter of patients in the study were previously treated with anti PD-L1/PD-1 therapy, which is a standard treatment for patients with locally advanced or metastatic bladder cancer. Responses to Balversa were seen in patients who had previously not responded to anti PD-L1/PD-1 therapy.
Balversa received an Accelerated Approval, Balversa was also granted Breakthrough Therapy designation.
The FDA granted the approval of Balversa to Janssen Pharmaceutical.
24 May 2019
Piqray (alpelisib) FDA approves first PI3K inhibitor for breast cancer.
The efficacy of Piqray was studied in the SOLAR-1 trial, a randomized trial of 572 postmenopausal women and men with HR-positive, HER2-negative, advanced or metastatic breast cancer whose cancer had progressed while on or after receiving an aromatase inhibitor. Results from the trial showed the addition of Piqray to fulvestrant significantly prolonged progression- free survival (median of 11 months vs. 5.7 months) in patients whose tumors had a PIK3CA mutation.
Piqray is the first new drug application (NDA) for a new molecular entity approved under the Real-Time Oncology Review (RTOR) pilot program, which permits the FDA to begin analyzing key efficacy and safety datasets prior to the official submission of an application, allowing the review team to begin their review and communicate with the applicant earlier. Piqray also used the updated Assessment Aid (AAid), a multidisciplinary review template intended to focus the FDA’s written review on critical thinking and consistency and reduce time spent on administrative tasks. With these two pilot programs, today’s approval of Piqray comes approximately three months ahead of the Prescription Drug User Fee Act (PDUFA) VI deadline of August 18, 2019.
The FDA granted this application Priority Review designation. The FDA granted approval of Piqray to Novartis.
10 June 2019
FDA approves first chemoimmunotherapy regimen for patients with relapsed or refractory diffuse large B-cell lymphoma
Efficacy was based on complete response rate and duration of response (DOR), defined as the time the disease stays in remission. At the end of treatment, the complete response rate was 40% with Polivy plus BR compared to 18% with BR alone. Of the 25 patients who achieved a partial or complete response to Polivy plus BR, 16 (64%) had a DOR of at least six months and 12 (48%) had a DOR of at least 12 months.
Polivy in combination with BR was granted accelerated approval, The FDA granted this application Breakthrough Therapy and Priority Review designations. The FDA granted the approval of Polivy to Genentech.
30 July 2019
NUBEQA (Bayer) is indicated for the treatment of patients with non-metastatic castration resistant prostate cancer (nmCRPC)
NUBEQA is a drug for the treatment of prostate cancer that has not spread to other parts of the body (non-metastatic) and no longer responds to a medical or surgical treatment that lowers testosterone (castration-resistant).
In patients with medical or previous surgical treatment to lower testosterone, NUBEQA increased the patients’ survival during which time the cancer did not spread [metastasis-free survival (MFS)]. The MFS for patients taking NUBEQA was about 40 months compared to about 18 months for patients taking a placebo.
The FDA approved NUBEQA based on evidence from one clinical trial (NCT02200614) of 1509 patients with non-metastatic, castrate-resistant prostate cancer.
02 August 2019
FDA approves first therapy for rare joint tumor
Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.
The approval of Turalio was based on the results of a multi-center international clinical trial of 120 patients, 59 of whom received placebo. The primary efficacy endpoint was the overall response rate (ORR) analyzed after 25 weeks of treatment. The clinical trial demonstrated a statistically significant improvement in ORR in patients who received Turalio, with an ORR of 38%, compared to no responses in patients who received placebo. The complete response rate was 15% and the partial response rate was 23%. A total of 22 out of 23 responders who had been followed for a minimum of six months following the initial response maintained their response for six or more months, and a total of 13 out of 13 responders who had been followed for a minimum of 12 months following the initial response maintained their response for 12 or more months.
The FDA granted this application Breakthrough Therapy designation and Priority Review designation. The FDA granted the approval of Turalio to Daiichi Sankyo.
15 August 2019
FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor
The ability of Rozlytrek to shrink tumors was evaluated in four clinical trials studying 54 adults with NTRK fusion-positive tumors. The proportion of patients with substantial tumor shrinkage (overall response rate) was 57%, with 7.4% of patients having complete disappearance of the tumor. Among the 31 patients with tumor shrinkage, 61% had tumor shrinkage persist for nine months or longer. The most common cancer locations were the lung, salivary gland, breast, thyroid and colon/rectum.
Rozlytrek was also approved today for the treatment of adults with non-small cell lung cancer whose tumors are ROS1-positive (mutation of the ROS1 gene) and has spread to other parts of the body (metastatic). Clinical studies evaluated 51 adults with ROS1-positive lung cancer. The overall response rate was 78%, with 5.9% of patients having complete disappearance of their cancer. Among the 40 patients with tumor shrinkage, 55% had tumor shrinkage persist for 12 months or longer.
Rozlytrek was granted accelerated approval. This approval commits the sponsor to provide additional data to the FDA. Rozlytrek also received Priority Review and Breakthrough Therapy designation. The approval of Rozlytrek was granted to Genentech, Inc.
14 November 2019
FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage
A single-arm clinical trial of Brukinsa included 86 patients with mantle cell lymphoma who had received at least one prior treatment. The trial measured how many patients experienced complete or partial shrinkage of their tumors after treatment (overall response rate). In the trial, 84% of patients had tumor shrinkage with a median duration of response (time between the initial response to therapy and subsequent disease progression or relapse) of 19.5 months. This trial was supported by an additional single-arm trial that included 32 patients, in which 84% of patients had tumor shrinkage with a median duration of response of 18.5 months.
Brukinsa was granted Accelerated Approval and Breakthrough Therapy Designation. The FDA granted approval of Brukinsa to BeiGene USA Inc.
18 Desember 2019
FDA approves new type of therapy to treat advanced urothelial cancer
Padcev was approved based on the results of a clinical trial that enrolled 125 patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy. The overall response rate, reflecting the percentage of patients who had a certain amount of tumor shrinkage, was 44%, with 12% having a complete response and 32% having a partial response. The median duration of response was 7.6 months.
Padcev was granted Accelerated Approval, Priority Review and Breakthrough Therapy designation. The FDA granted the approval of Padcev to Astellas Pharma US Inc.
20 December 2019
FDA approves new treatment option for patients with HER2-positive breast cancer who have progressed on available therapies
Enhertu’s approval was based on the results of a clinical trial enrolling 184 female patients with HER2-positive, unresectable and/or metastatic breast cancer who had received two or more prior anti-HER2 therapies in the metastatic setting. These patients were heavily pretreated in the metastatic setting, receiving between two and 17 therapies prior to receiving Enhertu. The overall response rate was 60.3%, which reflects the percentage of patients that had a certain amount of tumor shrinkage with a median duration of response of 14.8 months.
Enhertu was granted Accelerated Approval and Breakthrough Therapy Designation. Enerthu was also granted Fast Track. The FDA granted the approval of Enhertu to Daiichi Sankyo.
30 December 2019
FDA approved Lynparza (olaparib) as a maintenance treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) metastatic pancreatic adenocarcinoma (pancreatic cancer) whose disease has not progressed on at least 16 weeks of a 1st-line platinum-based chemotherapy regimen.
AstraZeneca and Merck are closing out 2019 on a high note with another approval for its PARP inhibitor Lynparza.
Approval for Lynparza in this indication was based on strong results from the Phase III POLO trial that showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as first-line maintenance therapy. In the trial, Lynparza nearly doubled the time patients with gBRCAm metastatic pancreatic cancer lived without disease progression or death to a median of 7.4 months versus 3.8 months on placebo. Trial data also showed that Lynparza reduced the risk of disease progression or death by 47%. Overall survival, which was a secondary endpoint, at interim analysis was 18.9 months for Lynparza versus 18.1 months for placebo. That did not reach statistical significance, the companies said. The safety and tolerability profile of Lynparza in the POLO trial was in line with that observed in prior clinical trials.
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Kommentar til 30/12.
Stabil OS. Uten sykdomsprogresjon forlenget med 3,6mnd. FDA maa väre bra desperate for aa gi AA med disse tallene.
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