https://preview.redd.it/ixlcambyn51e1.png?width=1547&format=png&auto=webp&s=00c24b1ee77e386fcb4e0c59f24ff2052452a75b

Mijn strategie is best bijzonder, maar levert tot nu toe (+/-) geld in het laatje op, combinatie van Covered Call en OTM Puts, op verschillende effecten met een lage VIX, maar wel optie-inkomstenpotentieel en ik kan natuurlijk ook gewoon JEPI kopen, maar dit is leuker jóh!

Zitten in defensie en elektrische Luchtvaart. Kan toch alleen maar een goede long time bet zijn?

Ik snap het nog niet helemaal

1. What are the applications of SunHydrogen’s technology?
While our immediate focus is fuel cell vehicles, we recognize and embrace the vast possibilities for green hydrogen application. Long term, we envision that our technology can be utilized in industrial, residential and commercial settings, as well as feedstock for various petrochemicals and products.

2. What is Gen 2 technology?

Our Gen 2 technology, also known as our nanoparticle technology, brings lower costs, improved efficiency and scalable potential. Powered by solar energy, billions of our microscopic nanoparticles split apart water at the molecular level, extracting hydrogen for use as a clean energy source and leaving behind only clean oxygen as a byproduct.

3. What is the company’s timeline for commercialization?
The timeline below outlines our progress toward the development and production phases of our technology. Projected targets are subject to change as we continue to engage new partners and identify the most efficient pathway to scale our technology.

https://preview.redd.it/quozm36ojo0e1.jpg?width=1567&format=pjpg&auto=webp&s=8ebd3db1b970ac5ac5a1f729c7bb6ab1814b94c2

Al t geld van mn opa’s en oma’s in Asts gedouwd. Ze willen 5G over de helen wereld providen, zodat je letterlijk overal internet hebt, ook in de middle of nowhere. Ze hebben nog geen revenue maar ze verwachten binnen enkele jaren een aantal miljard per jaar te verdienen wat met een PE van 20 en vrijwel geen goeie competitie (spacex tech is wack vergeleken met hun) hun stock makkelijk kan laten vertwintigvoudigen. Zou je er echt in verdiepen want deze shit gaat echt bijna gegarandeerd naar de maan over paar jaar (Asts subreddit goeie plek)

Join de Discord en praat gezellig mee over je gains en losses :) https://discord.gg/S8Y5QXJRXv

Een aandeel PostNL kost nu 1.053€, hoe slim is het om nu er wat van te kopen? Hoe groot is de kans dat het weer goed kan gaan met PostNL

Goedemiddag,

De korte termijn rente was afgelopen 2 jaar hoger dan de lange termijn rente (yield curve). Historisch gezien is een omgekeerde yield curve een van de betrouwbaarste voorspellers van een recessie (zie grafiek, het grijze gebied zijn periode's van recessies), waarbij bijna elke recessie sinds de jaren 1950 werd voorafgegaan door een dergelijke omkering. We hebben de afgelopen 2 jaar de langste yield curve-inversie ooit gezien. Sinds afgelopen maand (september) is de yield curve weer omgekeerd. Dus we kunnen een flinke recessie verwachten...

Vaak begon de recessie nadat de yield curve weer 'normaal' was binnen 12-18 maanden. Een recessie / downturn is niet te timen, ook de grootte van de recessie is niet te voorspellen. Wat zijn mogelijk optie's om toch te profiteren als je er vanuit gaat dat de markt de aankomende 12-18 maanden gaat dalen?
-Aandelen shorten, welke gaan het hardst in economisch mindere tijden, luxegoederen? (LVMH?)
-Inversed ETF zoals SOXS / TECS (3x leveraged)?
-Call opties verkopen (schrijven), uiteraard niet ongedekt dus een call met een hogere uitoefenprijs kopen, maar daardoor wel premie.
-Defensie aandelen / ETF's?
-Geld aan de 'zijlijn' houden?

• Verwachtingen
  • Nieuws UK approval, makkelijker/sneller dan EU (vanwege regels)
  • Liquidity is een groot probleem, ik verwacht een partnership. Daarom hoge SI
    • Ik verwacht een partner. Door vele trials is de cashburn veel te hoog
  • Sales Anktiva begon UNIEK 2 weken na FDA approval.
  • CEO is een sluwe vos, heeft miljarden verdient aan Bio.

=============================

• 31% Short
• 53 Million shares
• 34 Days to cover

==================================

ImmunityBio Presents Positive Long-Term Overall Survival Data in Non-Small Cell Lung Cancer Patients and Announces Registrational Intent Phase 3 Trials with ANKTIVA® and Checkpoint Immunotherapy at World Conference on Lung Cancer

• Phase 2 data presented at the World Conference on Lung Cancer showing a prolonged median overall survival of over 14 months in 2^(nd) and 3^(rd) line NSCLC cancer patients who progressed on checkpoint inhibitors such as KEYTRUDA (pembrolizumab) and OPDIVO (nivolumab)
• ANKTIVA plus KEYTRUDA or OPDIVO rescued T cell activity in these patients who progressed on the same checkpoint inhibitor with overall survival of 57% at 12 months
• Long-term survival was independent of PDL1 tumor status and independent of 2^(nd) or 3^(rd) line of therapy
• The data continues to validate the mechanism of action of ANKTIVA in activating NK, CD8 killer, and Memory T cells resulting in prolonged overall survival in patients with advanced cancers
• Data supports global launch of Phase 3 randomized control of ResQ trials of ANKTIVA plus KEYTRUDA or OPDIVO in 1^(st) and 2^(nd) line NSCLC (ResQ301 and ResQ302) versus standard of care

==========================================

8/9/2024

Bio Investments can be extremely risky. Once in a while we see a unique company pursuing unique science with massive potential.

• Immunity Bio's Anktiva a new blockbuster
  • ANKTIVA, developed by ImmunityBio, has received FDA approval for use in combination with BCG (Bacillus Calmette-Guérin) to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This drug leverages the immune system, particularly by stimulating natural killer (NK) cells and T cells, to fight cancer, offering a promising new treatment option for patients who previously faced invasive surgery
  • ANKTIVA is also being investigated for multiple other conditions, including various solid tumors, non-Hodgkin's lymphoma, non-small-cell lung cancer, and HIV
• Immunity Bio Finances at a glance
  • ImmunityBio is experiencing deficit and cash-flow challenges, according to the filing. As of June 30, the company had an accumulated deficit of $3.2 billion. It also had negative cash flows of $207.3 million during the six months ended June 30.
  • The company also said in the filing that it believes there is substantial doubt about its ability to continue without additional funding. However, it went on to note that its existing cash, cash equivalents and investments in marketable securities; sales of approved product; capital to be raised through equity offerings; and potential ability to borrow from affiliated entities will fund operations through at least 12 months.
• Understanding the CEO
  • Soon-Shiong's net worth is $6.2 billion as of 2024. He has been called the richest man in Los Angeles and one of the wealthiest doctors in the world.
  • Soon-Shiong purchased Fujisawa, which sold injectable generic drugs, in 1998. He used its revenues to develop Abraxane, which took an existing chemotherapy drug, Taxol, and wrapped it in protein that made it easier to deliver to tumors. He was able to quickly move it through the regulatory process and made his fortune with this medicine
    • https://en.wikipedia.org/wiki/Patrick_Soon-Shiong#References
• ImmunityBio Strategic partnership in India.
  • Collaboration will result in BCG manufacture at large scale for use in combination with ANKTIVA®, ImmunityBio’s recently approved treatment for non-muscle invasive bladder cancer (NMIBC)
  • Serum Institute of India (SII) will manufacture both standard BCG (“sBCG”) and next-generation recombinant BCG (“iBCG”), creating a long-term solution to chronic BCG supply shortage issues
• Next indication approval
  • ImmunityBio Announces Positive Overall Survival Results of Anktiva Combined With Checkpoint Inhibitors in Non-Small Cell Lung Cancer; Meeting Scheduled with FDA to Discuss Registration Path for ANKTIVA in Lung Cancer
    • QUILT 3.055 trial completed and shows median overall survival almost double that of standard of care chemotherapy in 2^(nd)– and 3^(rd)-line non-small cell lung cancer (NSCLC) patients whose cancer did not respond to checkpoint inhibitors with or without chemotherapy.
    • Positive results seen in both PD-L1 negative and PD-L1 positive participants with NSCLC
    • Data reaffirms the mechanism of action of ANKTIVA as an immune cell enhancer that activates natural killer (NK) cells and memory T cells to rescue checkpoint inhibitor (pembrolizumab, nivolumab, atezolizumab) failures across multiple tumor types
• Presentation TODAY (08/09/2024)
  • Results: The median OS (n=86) was 14.1 months (95% CI 11.7, 17.4) with 24 ongoing survival to date. In 3^(rd) line+ve (n=25) median OS was 14.8 months (95% CI 9.1, 26.7). OS for PDL1+ve (>1%) (N=53) was 13.8 months (95% CI 10.2, 17.4) versus PDL1-ve (N=33) blah blah blah......... https://cattendee.abstractsonline.com/meeting/20598/Session/142Conclusions: Anktiva plus CPI therapy in 2nd line or greater NSCLC demonstrated long-term median OS, independent of PDL1 status, and independent of prior lines of therapy in patients with acquired resistance to CPI. These findings support the novel mechanism of action of Anktiva to rescue CPI activity through the activation of NK and T cells, driving long-term memory, with median OS ongoing survival of 33% and 30% at 18 and 21 months respectively, exceeding the standard of care.

OCUGEN Update, CEO statement. Vandaag waarschijnlijk non-compliance. Eerder dit jaar van 0,3 naar 1,8. Ik denk dat dit de 0,8 nog wel gaat aantikken, maar over een paar maandjes zeer zeker boven de 1,5$, indien een grote naam als partner - dan 2$-4$

https://x.com/NattaCop/status/1847085174322090151/video/1

=========================

• Ocugen heeft een zeer goede "gene therapy' met het doel blindheid tegen te gaan en/of zelfs te genezen
• Ocugen heeft een verleden, een vaccin-mishap, waardoor er vele bagholders boven de 2$ zweven
• Ocugen is weer bezig met marketing (see Yahoo PR's), we hebben meerdere malen gezien dat als ze hier mee bezig zijn dat het aandeel stijgt.
• Recentelijk zien we best wel wat funds instappen. Ook sinds juni aan Russell3000 verbonden
  • https://fintel.io/so/us/ocgn
• CEO is redelijk retail-friendly
• Voor het oog-gedeelte verwacht ik een partner groot van naam
  • Partnerships worden in hun documentatie beschreven, en ook op investor conferences besproken. CEO heeft aangegeven in Q1 2025 een partner voor Retinitis te willen hebben aangetrokken.
• Cash runway tot Q3 2025
• OS, zal voor velen ietwat aan de hoge kant zijn 275,000,000.
• Aandeel heeft meerdere malen de 2$ aangetikt.
• Pipeline
  • Ogen (zoals hieronder beschreven)
  • Knieën (NEOCART), halt vanwege gebrek aan funding (ik twijfel of dat nog wel komt). Essentieel is dit het repareren van 'cartilage' op een manier die hersteltijd versnelt. Deze methode heeft al een volledige PH3 ondergaan, maar miste endpoints. Het mooie is dat de CEO dus precies weet wat te doen om dit erdoor te drukken. Het nadeel, is dat de techniek wat betreft uitvoering geen voorstanders heeft onder chirurgen.
  • Vaccin - verwacht een update gezien NIAID (Fauci en consorten) hiermee bezig zijn. Ocugen heeft een vaccin om in te ademen voor ogen, NIAID zal de volledige trials betalen, Ocugen zal de rechten behouden. Als dit voeten krijgt, dan heeft Ocugen echt een superdeal in handen.

News

•  Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that Health Canada provided a “No Objection Letter” to initiate the OCU400 Phase 3 liMeliGhT (pronounced “limelight”) clinical trial in Canada. OCU400 is a modifier gene therapy product candidate being developed for retinitis pigmentosa (RP).
  • Ocugen previously announced that OCU400 has received orphan drug and RMAT designations from the FDA. OCU400 remains on track for the 2026 BLA and MAA approval targets.
    • These designations are indicators that increase the % of likelihood of approval
    • WATCH THIS VIDEO!!
    • https://ocugen.com/patients/#foobox-1/0/Patient_03-v7-B.mp4
• As you can see, my confidence in OCGN ha been unwaivering. Did notsell at 2$ (which means 400% up).
  • https://www.reddit.com/r/pennystocks/comments/1arc099/ocgn_see_progress_walk_on_to_dollarland/
• Excpected
  • NEOCART Funding - facility is ready for use. But it does take very long.
    • NEOCART has undergone a FULL phase 3. Got rejected by FDA, nearly missed endpoints. The beauty is, OCGN knows the road-map to approval. They did not build a facility to fail again.
  • NIAID Vaccin Update. IND application BY NIAID. Zero cost to OCGN, while keeping all the rights.
    • Recent studies in hamsters (Niet bij de Albert Heijn Hamsteren)
    • next-generation vaccines that target the virus’s points of entry — the nose and mouth — may be able to do what traditional shots cannot: contain the spread of respiratory infections and prevent transmission. Using a nasal COVID-19 vaccine based on Washington University technology, approved for use in India and licensed to Ocugen for further development in the U.S., the researchers showed that vaccinated hamsters that developed infections did not pass the virus on to others, breaking the cycle of transmission. In contrast, an approved COVID-19 vaccine that is injected failed to prevent the spread of the virus.
    • https://medicine.wustl.edu/news/nasal-covid-19-vaccine-halts-transmission/

https://ir.ocugen.com/static-files/33b3d0d8-6fa5-43ed-bd82-412e19d3b6c6

Die van 924 had ik natuurlijk gehaald voordat de cijfers van ASML bekend waren

Join de discord en laat je eigen plays zien (of lach de mijne uit)

https://discord.gg/BjaEpxCpN8

Na eerst al de apneugate van Philips hebben verwerkt en weer een dreun van ASML.

Wellicht maar overstappen naar enkel Amerikaanse fondsen.. heb toch het gevoel dat die minder forse bewegingen maken dan Europese

• Veren in eigen reet
  • https://www.reddit.com/r/BeurspleinBets/comments/1fl71qg/bbai_een_klein_ai_bedrijfje_super_airritant/
    • Dit bedrijf getipt. In mijn optiek een Squeeze kandidaat alsmede een solide long hold.
    • Check CEO interview https://finance.yahoo.com/video/bigbear-ai-stock-surges-165m-214005084.html
    • CEO is leuk, maar een sleutelfiguur in dit bedrijf is McAleen, voormalig Acting Secretary of Homeland Security en een leven lang border and customs control ervaring. Dude heeft een netwerlk

========================================

FIBROGEN 52 week low, no-brainer om X euro te verdubbelen. Kwestie van tijd. Kijkende naat de acties van het bedrijf, en kijkende naar het effect in de toekomst, is het niet moeilijk om te voorspellen hoe de boeken er over een paar maanden uitzien.

• Quick overview of facts
  • 75% reduction in USA workforce
  • Chief Medical Doctor departure
  • Chief Financial Officer departure
    • Saving millions in expenses
  • Cancel HQ
    • The above may indicate a sale of the company, the cost cutting is excessive. Saving approximately 20 million p/a
  • Lawsuit dismissed
    • oddly there was no PR
  • 150 million in cash (runway thru 2026)
    • Cash covers Covers debt
  • Increased revenue guidance
  • Expected China Indication approval with 10 Million milestone payment.

Thesis: Cleaned up balance sheet will lead to1,5$ by Q1 2025. Or, the excessive cost cutting and departure of CMO/CFO may hint at Fibrogen selling the company.

Veel hangt af van de 'indicatie approval' voor Rodux. Krijgen ze dit niet, dan gaat het een lastig verhaal worden. MAAR, kijkende naar de groei van Rodux en huidige groeiende marketshare, denk ik dat het met deze approval wel goed gaat komen. Dit kan volgende week zijn, of aan het eind van het jaar.

Gisteren zonder enige kennis eigenlijk gegokt dat de cijfers van Theon gisteren om 18:00 erg goed zouden gaan (en dat zijn ze ook) dus laat ik mijn nieuwe verrekijker pakken om te kijken hoe ver het omhoog zal gaan.

Gisteren ook per ongeluk een ASML call twv 3000 euro op margin gehaald maar had helaas papieren handen en heb die met 150 euro winst weggedaan

Wil je mij ook uitlachen toen ik de call per ongeluk had gehaald, join de Discord!

https://discord.gg/BjaEpxCpN8

Wat verwachten jullie? De koers begon dit jaar vanaf januari te pieken tot juli, waarbij de 1000 euro werd aangetikt. Daarna gedipt naar 600-800 en niet hersteld. Nu dus -25% tov de zomer.

Ik zit er sinds de dip long in.. maar ben benieuwd hoe deze sub ernaar kijkt?

Off the BAT (pun intended). JA! Sellas is een onder de radar stock, heeft een lange weg afgelegd, maar phase 3 REGAL komt aan een einde, met indicaties die volgen. SLS kent nogal veel vertraging, veelal omdat mensen niet sterven. Geweldig nieuws natuurlijk. Ik pump niet graag, maar ik denk dat 5 a 10 Dollar per share niet overdreven is als GPS fase 3 positief uitvalt. Faalt REGAL, dan kijken we naar 009 - vraag jezelf af - hoeveel experimentele drugs hebben zoveel designations wereldwijd?

Onderstaande een uitgebreide analyse, sources en natuurlijk ook een stukje bear-case. Ik vind het belangrijk om ook de downside te zien. In dit geval is het een CEO met een arrogante kop en het business acumen van een Gibbon....

=================================================

• Updated website is an indication management is marketing GPS, why would the company go through all this trouble for a drug that has been a decade in development and is in phase 3?
  • Proposed mechanism of action
  • https://sellaslifesciences.com/science/gps-proposed-mechanism-of-action-animation/
• Updated Clinical Trial (to be honest, I do not know what this means, but it coincides)
  • Last Update Submitted that met QC Criteria
  • https://clinicaltrials.gov/study/NCT01265433?intr=Galinpepimut-S&rank=5#publications
• Write up
  • https://valueinvestorsclub.com/idea/SELLAS_LIFE_SCIENCES_GROUP_I/9286565496
  • This is mostly opinion by a notorious pumper BUT there is ONE truth in here which I concluded myself back in January, the KOL said too much!
    • Key Trial Doctors Baldly State 'The Drug Works' in Public: In January 2024 update call, one of the key trial doctors commented that (i) he has personally enrolled over 10% of the patients into the Regal trial and (ii) he strongly believes that the trial will meet its primary endpoint; this is slightly paraphrased of course, as he's working under an NDA, but the transcript of this call is still available online, and his wording is unambiguous. It’s difficult to be more clear than he was in stating that GPS is effective, and he has a better-informed perspective than Sellas management themselves.

===========================================

• Galinpepimut-S, or GPS, the late Phase 3 asset which reads out imminently, is a cancer-immunotherapy or 'cancer vaccine', which prevents or delays the cancer from returning once remission has been achieved (referred to as a 'maintenance therapy' which maintains the remission state;
• SLS009 (formerly GFH009), in Phase 2 currently, is a selective CDK9 Inhibitor, which treats the active-disease state by clearing the overproduced white cells in a reasonably precise way, avoiding the toxicities which have been an issue with previous attempts at CDK9 Inhibition.
  • SLS 009
  • FDA ODD for the treatment of AML
  • FDA ODD for the treatment of PTCL -
  • FDA Fast Track Designation for the treatment of PTCL
  • FDA Fast Track Designation for the treatment of AML
  • EMA ODD for SLS009 for the Treatment of Acute Myeloid Leukemia
  • FDA RPDD Granted to SLS009 for the Treatment of Pediatric Acute Lymphoblastic Leukemia
  • FDA RPDD Granted to SLS009 for the Treatment of Pediatric Acute Myeloid Leukemia
  •  Orphan Drug Designation (ODD) for SLS009

========================================

• Pipeline Highlights Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeuti
  • Phase 3 REGAL study in AML: The IDMC conducted a prespecified risk-benefit assessment of unblinded data from the study in June and has recommended that the trial continue without modifications. Based on a detailed analysis of all unblinded data, the IDMC projects that the interim analysis (60 events) will occur by the fourth quarter of 2024.
• SLS009: highly selective and specific CDK9 inhibitor
  • Completed Enrollment in Phase 2a Trial of SLS009 in AML: 30 patients relapsed after or refractory to venetoclax-based regiments were enrolled ahead of schedule in 5 centers across the US. Except for one, all patients in this Phase 2a trial had adverse risk AML (97%) and were treated with continued venetoclax–azacytidine combination therapy after having failed it or similar venetoclax-based combinations, often more than once. The expected overall survival in those patients is approximately 2.5 months.
  • Announced Positive Initial Phase 2 Data of SLS009 in AML: The preliminary data showed the overall response rate (ORR) of 33% and 50% in 60 mg QW and 30 mg BIW cohorts, respectively. The ORR in patients with ASXL1 mutation in the 30 mg BIW reached a remarkable 100% to date. In the safety dose of 45 mg QW, the median overall survival (mOS) was 5.4 months vs 2.5 months with standard of care. The mOS in 60 mg QW and 30 mg BIW has not been reached yet. SLS009 was well-tolerated across all doses.
  • Additional Phase 2 Cohorts in Venetoclax Combinations in AML Opened for Enrollment: Development of SLS009 continued with the opening of two new cohorts - AML with myelodysplasia-related changes (AML MRC) with ASXL1 mutations and AML with myelodysplasia related changes other than ASXL1 mutations. These new cohorts are also open for enrollment of certain pediatric patients.
  • National Institute of Health PIVOT program in Pediatric Tumors: The program in multiple pediatric cancer indications continues in collaboration with the National Cancer Institute (NCI). Initial safety and efficacy data are expected to be reported throughout 2H 2024.
  • Recently Granted Regulatory Designations for SLS009: The FDA granted Rare Pediatric Disease Designation (RPDD) to SLS009 for the treatment of pediatric ALL in June 2024 and the FDA granted RPDD to SLS009 for the treatment of pediatric AML in July 2024. Also, the EMA granted Orphan Drug Designation for SLS009 in AML and in PTCL in June 2024 and July 2024, respectively. The FDA previously granted SLS009 Orphan Drug Designations in AML and PTCL and Fast Track designations for AML and PTCL.

=============================================

• Positives

  • TWO candidates that simply are worth billions
  • Sellas is unable to commercialize, the team in not set up, there are no facilities to produce, no sales in place, there must be a partner or buy-out at the end of the road. This is clear as daylight.
  • Two existing funds bought in at 1,20 and 1,35. These funds are likely controlling the stock. The stock has not moved down with the market, and it does not move down either

• Negatives

  • Clear manipulation of the stock. Maxim Group, Anson. There is a lot to dislike about the players in this stock. Watching the tape the mid and big buys all show OTC. This is a clear cut sign of manipulation.
  • CEO with a god-complex that has fumbled the ball many many times. Of course running a bio is extremely complex.
    • Going through Sec filings, inside ownership is too low, expenses for operating too high, too lavish.
  • The 3D China f-up. There is arbitration going on for over a year now, no updates. Yet, Sellas touts milestone payments that have never been received and may not be received.. This massive failure has caused double dilution.
  • Shenanigan by CEO and funds will lead to law suits if GPS or 009 fails. It is so on the nose, the average retailer can see it.

176% in de plus

Gewoon geluk gehad denk ik

• 50 Million Short
• 30% Of float
• 27 days to cover
  • Redenen
    • Liquidity problemen
    • Schuld
    • Hoogst waarschijnlijk een short = long scenario, waarbij WS van twee walletjes vreet.
• Short seller dreiging
  • Eigenaar heeft 80% van de aandelen in handen
  • Eigenaar is een Dr en zakenman die precies weet wat hij doet.
    • Essentieel zijn de schulden geen probleem als Anktiva in de breedte effectief is. Binnen een jaar of twee meerdere approvals binnen weet te harken (de OPDIVO Wiki geeft goed inzicht hoe een blockbuster medicijn/therapie indicatie approvals binnen kan harken
  • UK approval werkt anders dan Europese goedkeuring. In de UK is FDA approval genoeg om binnen enkele maanden de markt op te kunnen.

Mijn verwachting is dat er een serie PR's aan gaan komen die dit aandeel terug naar 10$ gaan stuwen. Het aandeel is immens populair onder retail, die al een gelijkwaardige route hebben ondergaan. En natuurlijk een legertje bag-holder (zoal ik) die een lager gemiddelde willen hebben. Mijn gemiddelde is 4.3 Euro.

================================================

ImmunityBio Presents Positive Long-Term Overall Survival Data in Non-Small Cell Lung Cancer Patients and Announces Registrational Intent Phase 3 Trials with ANKTIVA® and Checkpoint Immunotherapy at World Conference on Lung Cancer

• Phase 2 data presented at the World Conference on Lung Cancer showing a prolonged median overall survival of over 14 months in 2^(nd) and 3^(rd) line NSCLC cancer patients who progressed on checkpoint inhibitors such as KEYTRUDA (pembrolizumab) and OPDIVO (nivolumab)
• ANKTIVA plus KEYTRUDA or OPDIVO rescued T cell activity in these patients who progressed on the same checkpoint inhibitor with overall survival of 57% at 12 months
• Long-term survival was independent of PDL1 tumor status and independent of 2^(nd) or 3^(rd) line of therapy
• The data continues to validate the mechanism of action of ANKTIVA in activating NK, CD8 killer, and Memory T cells resulting in prolonged overall survival in patients with advanced cancers
• Data supports global launch of Phase 3 randomized control of ResQ trials of ANKTIVA plus KEYTRUDA or OPDIVO in 1^(st) and 2^(nd) line NSCLC (ResQ301 and ResQ302) versus standard of care

=======================================================================

8/9/2024

Bio Investments can be extremely risky. Once in a while we see a unique company pursuing unique science with massive potential.

• Immunity Bio's Anktiva a new blockbuster
  • ANKTIVA, developed by ImmunityBio, has received FDA approval for use in combination with BCG (Bacillus Calmette-Guérin) to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This drug leverages the immune system, particularly by stimulating natural killer (NK) cells and T cells, to fight cancer, offering a promising new treatment option for patients who previously faced invasive surgery
  • ANKTIVA is also being investigated for multiple other conditions, including various solid tumors, non-Hodgkin's lymphoma, non-small-cell lung cancer, and HIV
• Immunity Bio Finances at a glance
  • ImmunityBio is experiencing deficit and cash-flow challenges, according to the filing. As of June 30, the company had an accumulated deficit of $3.2 billion. It also had negative cash flows of $207.3 million during the six months ended June 30.
  • The company also said in the filing that it believes there is substantial doubt about its ability to continue without additional funding. However, it went on to note that its existing cash, cash equivalents and investments in marketable securities; sales of approved product; capital to be raised through equity offerings; and potential ability to borrow from affiliated entities will fund operations through at least 12 months.
• Understanding the CEO
  • Soon-Shiong's net worth is $6.2 billion as of 2024. He has been called the richest man in Los Angeles and one of the wealthiest doctors in the world.
  • Soon-Shiong purchased Fujisawa, which sold injectable generic drugs, in 1998. He used its revenues to develop Abraxane, which took an existing chemotherapy drug, Taxol, and wrapped it in protein that made it easier to deliver to tumors. He was able to quickly move it through the regulatory process and made his fortune with this medicine
    • https://en.wikipedia.org/wiki/Patrick_Soon-Shiong#References
• ImmunityBio Strategic partnership in India.
  • Collaboration will result in BCG manufacture at large scale for use in combination with ANKTIVA®, ImmunityBio’s recently approved treatment for non-muscle invasive bladder cancer (NMIBC)
  • Serum Institute of India (SII) will manufacture both standard BCG (“sBCG”) and next-generation recombinant BCG (“iBCG”), creating a long-term solution to chronic BCG supply shortage issues
• Next indication approval
  • ImmunityBio Announces Positive Overall Survival Results of Anktiva Combined With Checkpoint Inhibitors in Non-Small Cell Lung Cancer; Meeting Scheduled with FDA to Discuss Registration Path for ANKTIVA in Lung Cancer
    • QUILT 3.055 trial completed and shows median overall survival almost double that of standard of care chemotherapy in 2^(nd)– and 3^(rd)-line non-small cell lung cancer (NSCLC) patients whose cancer did not respond to checkpoint inhibitors with or without chemotherapy.
    • Positive results seen in both PD-L1 negative and PD-L1 positive participants with NSCLC
    • Data reaffirms the mechanism of action of ANKTIVA as an immune cell enhancer that activates natural killer (NK) cells and memory T cells to rescue checkpoint inhibitor (pembrolizumab, nivolumab, atezolizumab) failures across multiple tumor types
• Presentation TODAY (08/09/2024)
  • Results: The median OS (n=86) was 14.1 months (95% CI 11.7, 17.4) with 24 ongoing survival to date. In 3^(rd) line+ve (n=25) median OS was 14.8 months (95% CI 9.1, 26.7). OS for PDL1+ve (>1%) (N=53) was 13.8 months (95% CI 10.2, 17.4) versus PDL1-ve (N=33) blah blah blah......... https://cattendee.abstractsonline.com/meeting/20598/Session/142Conclusions: Anktiva plus CPI therapy in 2nd line or greater NSCLC demonstrated long-term median OS, independent of PDL1 status, and independent of prior lines of therapy in patients with acquired resistance to CPI. These findings support the novel mechanism of action of Anktiva to rescue CPI activity through the activation of NK and T cells, driving long-term memory, with median OS ongoing survival of 33% and 30% at 18 and 21 months respectively, exceeding the standard of care.
• Conclusion (or my opinion)
  • IBRX has in Dr. Soon a business man that knows how to invest and get returns. It is likely IBRX will have all rights to USA/North America - but will partner with Big Pharma (J&J, Astra or so) for EMEA region. Looking at his previous businesses, I assume he will do the same once again. Sell/partner at the right moment. Estimated sales is 900 million p/a by 2028. That is for 1 indication only.
  • A partnership will likely alter the balance sheet of IBRX, see an upfront payment and milestone payments too.
    • Part of my thesis is UK approval. While Europe approvals take time, UK approval is easier. due to the International Reliance Procedure [7]. If the MHRA decides to take this road for approving Anktiva, then (at least theoretically) a UK approval could be a fact within 2024............ And guess where the plane of the Dr. has been this August Yes, Heathrow.

Heeft iemand hier een tasty trade account? Zo ja, hoe lang duurde voordat je account werd verwerkt door tasty trade?

Heb 2 weken geleden een account aangemaakt en alle documenten geupload, maar heb tot heden geen bevestiging gekregen. Op mijn account staat "Processing..." met onderaan tekst dat het binnen 3 dagen zal verwerkt worden. Vandaar de vraag is het normaal dat het zo lang duurt.

Gisteren AKTS, mooie 15% run eind van de dag. Vandaag

• Big Bear Ai , notities (uut mien kop)
  • De chart zal weergeven 1,20 - 1,50 is home-base
  • Management is super irritant, doen geen Earning Calls. Schrijven liever briefjes.
  • Slepen mooie contracten binnen, zoals
    • Heathrow Airport
    • Federal Aviation Administration, sub-contractor, niet erg speciaal maar
    • VERWACHTING, defense (army, navy) contracten en meer vliegvelden
  • Financiën
    • Niet zo heel erg rooskleurig, maat ach... start-ups.
    • Inside ownership en institutional ownership 50% en 8%, 250m OS, float 120m
    • Short interest, Fintel data, 60%+ - behoorlijk extreem. Maar, 11 dagen to cover, zou bij een waardevolle PR voor een perfect storm kunnen zorgen. MAAR, aan de andere kant zouden we kunnen stellen dat (door schulden en verliezen) Wallstreet niet veel vertrouwen in BBAI heeft?
  • Palantir
    • As part of the integrated product offering, Palantir’s Foundry platform will be integrated with BigBear.ai’s Observe, Orient and Dominate products, creating powerful machine learning extensions for the Palantir ecosystem that will provide global data collection, generate actionable insights and deliver anticipatory intelligence at enterprise scale to address high-growth federal and commercial verticals including space, retail, logistics and energy.
    • https://bigbear.ai/newsroom/bigbear-ai-and-palantir-announce-strategic-partnership-combining-ai-powered-products-with-next-generation-operating-platform/

https://finance.yahoo.com/quote/BBAI/

Een favoriete Bio is Sellas Life Science.

1. 009 en GPS zijn twee serieuze kandidaten om het door Phase 3 te halen
   • https://sellaslifesciences.com/pipeline/
   • Op de website even naar de KOL webcast luisteren van Jan en Mei
2. Sellas heeft 3 grote investeerders die onlangs tussen 1,20 en 1,35 behoorlijk hebben ingelegd. Dilution gedaan voor 2024 (denk ik)
3. Data verwacht mbt beide kandidaten tussen nu en eind 2024
4. 43$ valuation, dikke onzin natuurlijk, maar als data voor beiden positief is zie ik dit aandeel wel groeien naar 5$+
   • https://finance.yahoo.com/news/sellas-life-sciences-group-inc-190923404.html
5. Waar ik vaak op let bij Bio zijn de designations (zie hieronder). Elke designation vergroot de kans op approval met een X aantal %. Dat zit met 009 wel goed!
6. Natuurlijk zijn er nadelen
   • Op de tape zien we ongekende OTC rerouting. Ik denk dat dit aandeel laag gehouden wordt door de betrokken fondsen. Het aandeel beweegt niet met de markt, heeft het nooit gedaan.
   • Cash runway kon langer zijn
   • SLS is in arbitration met 3D Medicine China, die hebben een conflict (ik denk dat 3D simpelweg niet kan betalen). Het kan zomaar zijn dat de Chinezen ineens hun 30 miljoen ophoesten, of dat ze gewoon verdwijnen. Hoe dan ook... in het verleden drama zat.

Waar het uiteindelijk om draait zijn deze twee kandidaten:

• GPS in Acute Myeloid Leukemia (AML):
  • Median overall survival (OS) of 21 months in GPS-treated patients compared to 5.4 months in a historical control group.
    • A significant portion of GPS-treated patients remained in remission longer than expected.
    • In particular, patients with certain biomarkers (like HLA-A2) seemed to respond better to GPS, potentially indicating predictive biomarkers for response.
• SLS 009 - never mind the technical results - just look at what agencies are awarding
  • FDA ODD for the treatment of AML
  • FDA ODD for the treatment of PTCL -
  • FDA Fast Track Designation for the treatment of PTCL
  • FDA Fast Track Designation for the treatment of AML
  • EMA ODD for SLS009 for the Treatment of Acute Myeloid Leukemia
  • FDA RPDD Granted to SLS009 for the Treatment of Pediatric Acute Lymphoblastic Leukemia
  • FDA RPDD Granted to SLS009 for the Treatment of Pediatric Acute Myeloid Leukemia
  •  Orphan Drug Designation (ODD) for SLS009
    • The more designations, the higher the chance of approval and the more interesting to Big Pharma for partnerships.
  • Results May 2024
    • The Company Filed IP Protection Related to the ASXL1 Mutation, a Highly Prevalent Gene Mutation in Myeloid Malignancies and Solid Tumors With Significant Market Potential –
    • 100% Overall Response Rate in Patients with ASXL1 Mutation in the SLS009 30mg BIW Cohort to Date, All Patients Alive: Further Support for Potential Accelerated Approval Pathway in Defined Patient Population
    • SLS009 Exhibits Strong Anti-Leukemic Activity in 62% of Patients with a Favorable Safety Profile Across All Dose Levels and 67% in the 30 mg BIW Cohort –
    • Study Enrollment Ongoing at 30mg BIW Dose of SLS009 with Expansion Cohort of ASXL1 Mutation Patients; Updates Expected in Q3 2024 –