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Aandeel Affimed NV OTC:AFMD.Q, NL0010872420

  • 3,240 9 aug 2022 22:00
  • -0,040 (-1,22%) Dagrange 3,120 - 3,270
  • 568.080 Gem. (3M) 1,1M

Forum Affimed geopend

3.773 Posts
Pagina: «« 1 ... 154 155 156 157 158 ... 189 »» | Laatste | Omlaag ↓
  1. forum rang 7 Tom3 31 december 2021 18:53
    We strompelen in stijl het oude jaar uit.

    Het management van het LSP Fund voert de volgende oorzaken aan:

    While the capital markets performed very well in 2021, healthcare and biotech in particular have dramatically underperformed. Much has already been written to try to explain this dichotomy. Why is the market negative for biotech when it is innovation in healthcare which is ‘saving’ us from the pandemic? We can point to the good performance of the sector in 2020 in the wake of the first wave of the pandemic – were valuation too high at the start of 2021? Is it the on-going pandemic and a flight from risk? Biotech companies are certainly considered to be at the high end of any risk assessment. Has there been a lack of M&A transactions? It is true that this year lacked the kind of M&A transactions which get investors excited about the sector. The excitement about healthcare in 2020 led to several US fund seeing very large inflows – this appears to have led to a bubble at the start of 2021 as these
    fund had to rapidly deploy large amounts of capital (ARK Invest being an example). But even taking this spike and re-set seen in February/March of this year out of the equation, the sector has underperformed. There are several sector specific factors which came into play. With a new administration in the White House, the question of drug pricing was back in focus. This always causes uncertainly until the new strategy is defined. A second major impact of the new administration is the lack of leadership at FDA. The agency is under pressure due to increased work relating to the pandemic, there have been an unprecedented number of clinical trials relating to vaccine and anti-viral drug development which needed attention. Not to mention the Emergency Use Authorisations which were necessary. This has resulted, or so it seems, in a larger then usually number of delays to drug authorisations and above average number of trials being put on clinical hold. Any factors suggesting increased risk to drug development are negative for biotech investor sentiment. So, what does all this mean? In essence – it is not clear why biotech has underperformed so dramatically in 2021. Most likely it is a combination of all the factors mentioned about – the perfect storm so to speak. There have been many positive, impactful events in our portfolio companies this year, which have not resulted in positive share price performance. However, we believe that the underlying value of these companies has increased and will be reflected eventually. There are several catalysts to come in the portfolio this year. If these are positive, they will increase the underlying value and we are
    hopeful that this will also be reflected in the share price. If that does not happen, then the large number of pharma and larger biotech companies which strong balance sheets will no doubt take notice.
  2. forum rang 7 Tom3 2 januari 2022 20:47
    quote:

    Ontop1 schreef op 2 januari 2022 14:09:

    Zoals hierboven was het wel een dramajaar
    Het is dat ik Kadmon en Trillium in mijn porto had .
    Moge 2022 beter zijn voor de Biotech sector
    Nog verder de beste wensen voor 2022.

    Ook de beste wensen!

    Voor veel particuliere investeerders in Affimed is 2021 inderdaad op een rampjaar uitgelopen omdat, traditiegetrouw, de meesten zullen zijn ingestapt toen het aandeel naar $12 schoot. Die zie je dus niet zo snel terug. Ik vermoed verder dat instituten (als een Pictet) hier dankbaar gebruik van hebben gemaakt. De enige domper voor de onderneming was in mijn ogen dan ook het terugtrekken van Genentech uit het BCMA programma dat jammer genoeg de spectaculaire resultaten van AFM13+ cbNK cellen overschaduwde. Was dat terecht? Ik denk van niet: in de race naar een medicijn tegen de ziekte van Kahler is inmiddels een ware lawine van kandidaten (ook bij Roche zelf) ontstaan die inderdaad veelbelovend zijn. Maar CD30 en EFGR? Daar heeft Affimed in mijn beleving toch een verdraaid goede concurrentiepositie. Het zelfde kan voor CD123 gezegd worden. Ik ben dus hoopvol gestemd voor het nieuwe jaar.
  3. forum rang 6 Hulskof 5 januari 2022 12:34
    HEIDELBERG, Germany, Jan. 05, 2022 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that its Chief Executive Officer Dr. Adi Hoess will present at the 40th Annual J.P. Morgan Healthcare Conference on Thursday, January 13, 2022 at 10:30 a.m. Eastern Standard Time / 16:30 Central European Time.

    A live webcast of the presentation may be accessed on Affimed’s website at www.affimed.com/investors/webcasts-an... or at jpmorgan.metameetings.net/events/heal... and will be available for 30 days following the event. For more information or to schedule a one-on-one meeting with Affimed management, please contact Alex Fudukidis via email at a.fudukidis@affimed.com or phone at +1 (917) 436-8102.
  4. forum rang 7 Tom3 5 januari 2022 22:22
    quote:

    harvester schreef op 5 januari 2022 08:43:

    [...]

    Het volume is lager dan.normaal dus het zegt niet veel.
    Het is nu even een nieuwsloze periode en het biosentiment is ook even negatief.
    Opvallend was dat in de laatste minuten het volume fors omhoog ging zonder dat de koers (nog) verder door het putje ging. Als biotechbelegger is het de kunst je te blijven focussen op de gang van zaken in de kliniek. De rest zal wel een keer overwaaien. Wel prettig natuurlijk dat je niets moet verkopen. In de VS zou dat zo maar anders kunnen zijn. Er zijn waarschijnlijk zat hedge funds die niet vies zijn van leverage.
  5. forum rang 6 Hulskof 6 januari 2022 12:33
    Affimed Announces Completion of Enrollment in REDIRECT, the Registration-Directed Study of AFM13 in PTCL, and Provides Business Update

    Enrollment of REDIRECT study (AFM13-202) is completed; topline clinical readout expected in 2H 2022
    FDA approves protocol amendment to allow for (i) enrollment of up to 40 patients at the highest dose level, and (ii) treatment of patients with more than two cycles in the investigator sponsored trial of cord blood-derived natural killer (cbNK) cells pre-complexed with AFM13 (AFM13-104)
    Broad development strategy launched for AFM24 – enrollment initiated in three studies addressing major EGFR-expressing solid tumor indications including non-small cell lung and colorectal cancer
    For AFM28 a first in human study initiation is planned for second half of 2022
    Cash position provides funding into 2H 2023

    HEIDELBERG, Germany, Jan. 06, 2022 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it has completed enrollment in the REDIRECT study and provided a business update.

    REDIRECT, also known as AFM13-202 (NCT04101331), is a registration-directed phase 2 open-label, multicenter, global study investigating the efficacy and safety of AFM13 monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL). Affimed expects to report topline data from the REDIRECT study in the second half of 2022.

    “Completing the enrollment in the registration directed trial of AFM13, our lead innate cell engager, is an important milestone for us and reflects our ability to progress and advance our clinical pipeline. The high response rates reported in December 2021 from our combination study with natural killer cells in Hodgkin Lymphoma represent a marked expansion of the business opportunity of AFM13. We are looking forward to solidifying the opportunity for AFM13 when we report additional data this year,” said Dr. Adi Hoess, Chief Executive Officer of Affimed. “Data generated from multiple AFM13 trials provide us with confidence in the development strategy for AFM24 and AFM28, for which we expect to provide additional updates during 2022.”

    The REDIRECT trial protocol, in addition to the registration relevant cohorts A and B in PTCL, includes an arm to investigate AFM13 therapy in patients with Transformed Mycosis Fungoides (TMF), which is exploratory and not relevant to the potential consideration for accelerated approval. As previously announced, recruitment of TMF patients was paused due to the COVID-19 pandemic. At this time, Affimed has decided not to pursue the investigation of AFM13 therapy in patients with TMF due to the continuing impact of the COVID-19 pandemic and the completion of enrollment of the registration-directed portion of the trial.
  6. forum rang 6 Hulskof 6 januari 2022 12:33
    Update on Other Programs

    AFM13 (CD30/CD16A ICE®)
    The United States Food and Drug Administration (FDA) has approved a proposed amendment to the AFM13-104 trial protocol to increase the patient population treated at the recommended phase 2 dose (RP2D) to 40 CD30-positive lymphoma patients, including both Hodgkin Lymphoma (HL) patients and non-Hodgkin Lymphoma (NHL) patients, and allow for the treatment of patients with more than the two cycles of therapy, at the investigator’s discretion. With the approval of the protocol amendment, The University of Texas MD Anderson Cancer Center (MDACC) has initiated enrollment of patients into the phase 2 portion of the trial, triggering an undisclosed milestone payment to MDACC which Affimed expects to make during the first quarter of 2022.

    AFM13-104 is an investigator sponsored trial (IST) at MDACC investigating the treatment of CD30-positive lymphoma patients with cbNK cells, pre-complexed with AFM13. In December 2021, Affimed reported updated data from the trial, including a 100% objective response rate after a single cycle of treatment for the 13 patients treated at the RP2D of 1x108 cbNK cells precomplexed with AFM13 followed by 3 weekly infusions of AFM13. All three patients treated at the RP2D with at least 6 months of follow-up remained in complete response as of the cutoff date.

    AFM24 (EGFR/CD16A ICE®)
    During the fourth quarter of 2021, Affimed announced that it had identified the RP2D for AFM24 monotherapy of 480 mg weekly in patients with EGFR-expressing solid tumors. With the achievement of this milestone, Affimed has now embarked on a broad development strategy for AFM24, which includes the initiation of three studies investigating various EGFR-expressing solid tumor indications.

    Affimed has initiated enrollment in the expansion phase of the monotherapy AFM24 trial at the RP2D. The trial includes patients with renal cell carcinoma (clear cell), non-small cell lung cancer (EGFR-mutant) and colorectal cancer.

    Affimed also initiated enrollment in two separate phase 1/2a combination studies. The first is investigating the combination of AFM24 with SNK01 (ex vivo expanded and activated autologous NK cell therapy from NKGen Biotech) to treat patients with non-small cell lung cancer (NSCLC, EGFR-wildtype), squamous cell carcinoma of the head and neck, and colorectal cancer. The second study will investigate the combination of AFM24 with Roche’s atezolizumab, an anti-PD-L1 checkpoint inhibitor to treat patients with non-small cell lung cancer (EGFR-wildtype), gastric and gastroesophageal junction adenocarcinoma and pancreatic/hepatocellular/biliary tract cancer.

    Affimed expects to report data updates from the AFM24 trials during 2022.

    AFM28 (CD123/CD16A ICE®)
    AFM28 is currently being prepared for clinical evaluation with an IND filing planned for the first half of 2022 and a first in human study is planned to start in second half of 2022. Initial preclinical data for AFM28 was presented at the 63rd American Society of Hematology Annual Meeting (ASH) in December 2021, demonstrating antibody-dependent cell-mediated cytotoxicity (ADCC) even at low CD123 expression which was more pronounced compared to conventional anti-CD123 antibodies. In addition, AFM28 showed a 100-fold more potent NK cell activation in an ex vivo analysis, compared to Fc-enhanced IgG1 antibodies. Further, AFM28 was well tolerated and showed pharmacodynamic activity in cynomolgus monkeys.

    Preliminary Cash Balance and Cash Runway Guidance
    As of December 31, 2021, Affimed’s preliminary unaudited cash and cash equivalents were approximately €197 million. The cash balance includes €7.4 million of net proceeds received from the second tranche of Affimed’s loan agreement with Silicon Valley Bank, which was drawn in December 2021. Based on its current operating plan and assumptions, Affimed anticipates that its cash and cash equivalents will support operations into the second half of 2023.
  7. forum rang 6 Hulskof 6 januari 2022 12:40
    Per 31 dec 197 miljoen in kas, waaronder 7,4 uit inkomsten.
    Per 31 sep was er 198,7 miljoen in kas. Uitgaven kwamen toen op ruim 25 miljoen per kwartaal.
    Dan lijkt het er toch op dat er een kleine heimelijke emissie heeft plaatsgevonden de voorbije weken, waar o.a. Tom al van uitging. Anders zou de kas nu dichter bij de 150 miljoen moeten zitten...

  8. forum rang 6 Hulskof 6 januari 2022 13:29
    quote:

    Tom3 schreef op 6 januari 2022 12:54:

    All three patients treated at the RP2D with at least 6 months of follow-up remained in complete response as of the cutoff date.

    Dit lijkt me ook goed nieuws.
    Dat lijkt me een verwijzing naar wat ze in dec naar buiten brachten.
    Geen nieuwe update mbt de cr's, volgens mij.

  9. forum rang 6 Hulskof 6 januari 2022 13:36
    quote:

    Tom3 schreef op 6 januari 2022 13:14:

    De emissieactiviteiten in Q4 besloegen nog niet de helft van wat er mogelijk was ($100 miljoen) :

    www.davispolk.com/experience/affimed-...
    Dichter bij een kwart zelfs...

    198 + 7 - 25 = 180.
    197 - 180 = 17.

    Ervan uitgaande dat de q4 uitgaven wederom 25 miljoen betroffen.
3.773 Posts
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