Affimed Therapeutics B.V. - AFMD

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16.09.14 15:03
6

548 Postings, 2357 Tage NikGolAffimed Therapeutics B.V. - AFMD

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689 Postings ausgeblendet.

03.07.20 10:49
1

8147 Postings, 4512 Tage RichyBerlinChart

"..da es sich um eine massive Widerstandszone handelt.."
Echt? Kannst du das bitte mal bildlich darstellen. Ich kann da nichts massives entdecken. Danke
 

04.07.20 08:02

313 Postings, 1969 Tage Amadeus03Affimed Chart

 
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04.07.20 08:09

313 Postings, 1969 Tage Amadeus03und geht man zeitlich weiter zurueck......

04.07.20 08:12

313 Postings, 1969 Tage Amadeus03Affimed Chart

04.07.20 08:17
1

313 Postings, 1969 Tage Amadeus03Peinlich aber das war zu frueh

 
Angehängte Datei: affimed_n.pdf

04.07.20 19:51

8147 Postings, 4512 Tage RichyBerlinChart Affimed

Ja, waagerechte Widerstände sollte man nicht außer Acht lassen. Allerdings haben die nur eine relevante Aussage, wenn sie diverse Berührungen hatten und/oder die Kerzen an äußerst volumenstarken Tagen gebildet wurden.

Ich hätte da noch andere Vorschläge; Der Bereich 5,06/5,20 und der Bereich ~5,85?
 
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05.07.20 04:54

313 Postings, 1969 Tage Amadeus03Diverse Berührungen

Korrekt, aber eben genau das war der Fall und auch in 2015/2016.  

08.07.20 09:29
4

7472 Postings, 2844 Tage iTechDachsAktualisierung von Genentech Studie

einen Monat nach der ersten Veröffentlichung - weiterhin mit 5 Studienzentren in Australien, Norwegen und Dänemark, wobei eines in Dänemark Probanden aufnimmt. Damit dürften die 4 Wochen Wartezeit ohne Antibiotika vor der ersten Behandlung beim ersten Patienten bald erreicht sein, wobei die Liste der anderen Ausschlusskriterien sehr lang ist.

Meine EInschätzung - KEINE Handelsempfehlung.  

08.07.20 10:22

313 Postings, 1969 Tage Amadeus03Genentech Studie

Hallo IT Dachs - fällt denn ein Meilenstein an?  

08.07.20 10:47
2

7472 Postings, 2844 Tage iTechDachsDer wird wohl von allen erwartet und

wurde vom Affimed CEO auch mehrfach angedeutet (z.B. Juni Präsentation).
Typisch wäre die Behandlung des ersten Patienten in einer klinischen Studie als Auslöser.
 
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09.07.20 14:16
3

7472 Postings, 2844 Tage iTechDachsSchützenhilfe vom Land ?

In the fight against tumour cells, the company Affimed GmbH relies on the weapons of the innate immune system. Affimed has developed special innate cell engagers, which are antibodies that recognise tumour cells.
in einem interessanten englischsprachigem Artikel des Landes Baden-Württemberg ...  

09.07.20 17:12
2

7472 Postings, 2844 Tage iTechDachsUnd noch ein Artikel über den CEO

von der eigenen IR-Abteilung hinterher geschoben  - es sieht so aus, als ob man trotz der schon gezogenen ATM weiterhin die PR Werbetrommel laufen lassen will.

Virtual Hiring of the C-Suite

Our CEO, Adi Hoess, was featured in this month's @PharmExec leadership column. Read about how he's navigated virtual hiring during #COVID19. https://t.co/8P2G2Kyhdr

? Affimed (@affimed) July 9, 2020


Vielleicht ein Lockaufruf für weitere Bieter in einem drohenden Buyout durch Genentech?

Meine Spekulation - KEINE Handelsempfehlung.  

10.07.20 09:24
2

313 Postings, 1969 Tage Amadeus03Aktualisierung der Unternehmenspräsentation

https://www.affimed.com/wp-content/uploads/...sentation-July-2020.pdf

leider ohne Hinweis auf Genentech (still pending S.20)  

10.07.20 13:54

5832 Postings, 1159 Tage VassagoAFMD 4.60$ (neues 52WH)

vorbörslich bei 4.27$ (-7%)  

10.07.20 14:59

313 Postings, 1969 Tage Amadeus03Einladung zur HV am 04.08. und interessant

in der Einladung wird bemerkt, dass man die Vorzugsaktien, welche als Schutz vor einer Übernahme gedacht waren (Giftpille) in normale Stammaktien wandeln möchte.  

10.07.20 18:25

3977 Postings, 1764 Tage clint65das mit dem Aktienrückkaufprogramm

und der poison pill kann ich nicht nachvollziehen. Vielleicht kann mir jemand den Gedankengang mal erklären. Danke im Voraus! Es wird auch spekuliert, das die 10 Prozent an Genentech als Beteiligung gehen könnten vor einem buyout.

Aber wie passen dann das ATM im Zusammenhang mit den Blockkäufen in letzter Zeit zusammen?

 

10.07.20 18:36
3

7472 Postings, 2844 Tage iTechDachsDer Rückkauf der eigenen Aktien soll vor allem den

Investoren gegebenenfalls bessere Liquidität geben und die eigenen Verpflichtungen z.B. im Rahmen von Mitarbeiterboni mit Aktien zum Marktpreis bedienen.
Die Giftpille war / ist so ausgelegt, dass eine feindliche Übernahme am Markt bislang durch die Ausgabe von Vorzugsaktien ausgestoppt werden konnte. Diese Möglichkeit ist laut Tagesordnung nun nicht mehr erforderlich.
Gleichzeitig hat man in den Verträgen der Aufsichtsrats- und Managementmitglieder eine 'change  of control' Passage aufgenommen, die Ihnen grosszügige Kompensationen im Falle der Übernahme gewährt.
All diese Änderungen ab der Hauptversammelung Anfang August  scheinen tatsächlich auf  eine leichteren Eigentümerwechsel bei entsprechenden Angeboten hinzudeuten.

Meine Meinung - KEINE Handelsempfehlung.  

11.07.20 05:37

313 Postings, 1969 Tage Amadeus03Aufstockung

Nach diesen Nachrichten gestern habe ich nochmal aufgestockt und werde es tendenziell weiter tun. Ich denke eine Übernahme erscheint mit diesen ganzen angedachten Maßnahmen als recht wahrscheinlich- vorausgesetzt es kommen gute Studiendaten. Ich wundere mich, dass der Kurs gestern nicht mehr zugelegt hat und sogar ganz ordentlich im Minus geschlossen hat.  

12.07.20 09:16

313 Postings, 1969 Tage Amadeus03ATM

...ich muss gestehen ich bin ziemlich verwirrt. Das ATM sollte groesstenteils ueber die Buehne gegangen sein. Die Bloecke haben bislang immer noch keine neue Grossaktionaersmeldung generiert.  Jetzt die Veraenderungen in der Satzung.  Mir kommt das so vor, als stuende dahinter ein Plan.  

14.07.20 18:55
1

313 Postings, 1969 Tage Amadeus03short position per 30.06.

wurden massiv auf ca. 4,9 Mio Stück erhöht von rund 1,9 Mio Stück  

21.07.20 12:51
1

7472 Postings, 2844 Tage iTechDachsNK-Zellen mit AFM-13 Kombinationsstudie

scheint jetzt beim Forschungspatner MD Anderson trotz COVID-19 gestartet zu sein.
Noch ohne offizielle Meldung und keine Handelsempfehlung von mir.
 

23.07.20 12:30
1

7472 Postings, 2844 Tage iTechDachsDingeling ... aktuell in der Roche Q2 Präsentation

23.07.20 12:39
1

7472 Postings, 2844 Tage iTechDachs#712 falls die Folie nicht zu sehen ist

der neue Name für AFM26 lautet bei Roche RG6296 und die Folien 69 / 70 sowie insbesondere Folie 163 zeigen den Status (auf letzterer mit Nennung von Affimed) als 1. Patient in Q3.

Zur Info - KEINE Handelsempfehlung.  

04.08.20 13:10

7472 Postings, 2844 Tage iTechDachsQ2 2020 Daten und Konferenz am 11-ten August

 Heidelberg, Germany, August 4, 2020 ? Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their...
 

11.08.20 13:14
1

313 Postings, 1969 Tage Amadeus03Q2


 
Affimed Reports Second Quarter 2020 Financial Results and Operational Progress



Continued progress in the AFM13 pTCL REDIRECT monotherapy study
AFM24 is recruiting patients in cohort 2 of a Phase 1/2a clinical trial
Genentech?s RO7297089 is actively recruiting patients into a first-in-human Phase I trial resulting in the achievement of a milestone payment under the terms of the collaboration
Data on AFM24 and RO7297089 (formerly AFM26) were presented at the virtual AACR II conference in June
Angus Smith joins the company as Chief Financial Officer
Dr. Annalisa Jenkins and Harry Welten added to the Supervisory Board
?92.6 million of cash, cash equivalents and current financial assets as of June 30, 2020, providing anticipated cash runway into the first half of 2022
Conference call and webcast scheduled for August 11, 2020 at 8:30 am EDT (14:30 CET)


Heidelberg, Germany, August 11, 2020 ? Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results for the second quarter 2020 and provided an update on clinical and corporate progress.

?Affimed?s first half performance demonstrates the strength of the new management team and our ability to stay focused on executing our business strategy despite the continuing challenge of the COVID-19 environment. Always with the patient in mind, we are committed to advancing our pipeline as well as continuing to deepen our research to unlock the full potential of the innate immune system to fight cancer,? said Dr. Adi Hoess, CEO of Affimed. ?We have multiple Innate Cell Engager (ICE®) programs in clinical development, both partnered and wholly-owned, which are the basis for providing a cadence of a continuous data output in 2020 and 2021.?



Development Program Updates
AFM13 (CD30/CD16A)
Affimed has now successfully activated 54 clinical study sites in 10 countries in the on-going Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with CD30-positive peripheral T-cell lymphoma (pTCL).  The study follows a two-stage Simon design with a preplanned interim analysis after 40 patients. At the current recruitment rate the company expects the readout of the interim analysis to happen in mid-2021.
The investigator-sponsored Phase 1 study with the University of Texas, MD Anderson Cancer Center (MDACC), which investigates the combination of AFM13 with allogeneic NK cells in CD30+ Lymphomas, has completed the required validation work in order to administer a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells. MDACC has recently posted this study as enrolling on its website and it is expected to recruit patients as soon as the COVID-19 conditions in Texas permit.



AFM24 (EGFR/CD16A)

AFM24-101, a first-in-human Phase 1/2a clinical trial of AFM24, the EGFR/CD16A targeted innate cell engager for relapsed/ refractory patients with advanced EGFR-expressing solid tumors continues to recruit according to plan in cohort 2.
AFM24-101 is an open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study to evaluate AFM24 as monotherapy in adult patients with advanced solid malignancies known to be EGFR-positive.
No dose limiting toxicity was observed in dose cohort 1.
A preclinical poster presentation was shown at the virtual AACR II conference in June on AFM24, demonstrating that it is differentiated from all other EGFR targeting entities: (i) it appears safe - no skin toxicity or other dose limiting toxicities (DLTs) in cynomolgus monkeys, (ii) it addresses a broad patient population ? AFM24 targets EGFR independent of its mutational status, and (iii) in contrast to monoclonal antibodies, AFM24 strongly activates NK cells and macrophages.  


Genentech Collaboration Update

The Genentech-partnered, novel BCMA-targeted innate cell engager for the treatment of multiple myeloma has now entered a first-in-human Phase I, open-label, multicenter, global dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of RO7297089. The milestone was achieved in the third quarter and triggers a payment in an undisclosed amount to Affimed, which is expected to be recognized in the Company?s third quarter 2020 financial statements.
At the June virtual AACR II conference, a preclinical poster presentation on RO7297089 showed potent cell killing in tumor cell lines employing NK cells as effector cells with minimal increase in cytokines.  A 4-week safety study in cynomolgus monkeys showed a favorable safety profile with no cytokine release or adverse findings at the 15 and 50 mg/kg tested dose levels. Furthermore, time- and dose-dependent reductions in serum IgG levels and plasma cell markers were observed suggesting selective killing of BCMA positive cells by engaging CD16a positive immune cells.


Preclinical Pipeline Update

Progress continues on AFM28 and AFM32 towards late stage preclinical development.


Management Appointments

Angus Smith joined the company as Chief Financial Officer on July 13. Mr. Smith brings broad biopharmaceutical experience to the company including financial strategy and planning, capital markets, business development and operations. Mr. Smith?s appointment completes the planned additions to the management team which now includes Dr. Andreas Harstrick, Chief Medical Officer and Dr. Arndt Schottelius, Chief Scientific Officer.


Additions to the Supervisory Board

Dr. Annalisa Jenkins and Harry Welten were appointed to the Supervisory Board during the recent Annual General Meeting of Shareholders. Dr. Jenkins brings a wealth of expertise in advancing clinical programs through development and regulatory approval. Mr. Welten is an accomplished financial executive who is well suited to help drive value-creating strategies for the company. These additions to the Supervisory Board are expected to further strengthen the company?s industry know-how, experience and diversity.


Second Quarter 2020 Financial Highlights

(Figures for the second quarter ended June 30, 2020 and 2019 are unaudited.)

As of June 30, 2020, cash, cash equivalents and current financial assets totaled ?92.6 million compared to ?104.1 million on December 31, 2019. During the quarter, the company received net proceeds of approximately ?20.8 million under its at-the-market (?ATM?) program.

Based on its current operating plan and assumptions, Affimed anticipates that its cash, cash equivalents and current financial assets will support operations into the first half of 2022.

Net cash used in operating activities for the quarter ended June 30, 2020 was ?15.0 million compared to ?5.6 million in the second quarter of 2019. The second quarter 2019 net cash used in operating activities included a milestone payment to the company from the Genentech collaboration.

Total revenue for the second quarter of 2020 was ?2.9 million compared with ?4.0 million in the second quarter of 2019. Revenue in 2020 and 2019 predominantly relate to the Genentech collaboration (2020: ?2.7 million, 2019: ?3.7 million). Revenue from the Genentech collaboration in the second quarter 2020 was comprised of revenue recognized for collaborative research services performed during the quarter.

R&D expenses for the second quarter of 2020 were ?11.7 million compared to ?11.5 million in the second quarter of 2019. Expenses in 2020 relate predominantly to our AFM13 and AFM24 clinical programs as well as to our early stage development and discovery activities.

G&A expenses for the second quarter of 2020 were ?2.6 million compared to ?2.3 million in the second quarter of 2019. The increase is primarily related to higher Sarbanes-Oxley compliance costs, as well as an increase in legal, consulting and audit costs.

Net loss for the second quarter of 2020 was ?12.2 million or ?0.16 per common share. For the second quarter of 2019, the company?s net loss was ?10.3 million or ?0.17 per common share.

Weighted number of common shares outstanding for the quarter ended June 30, 2020 were 79.2 million.

Affimed encourages shareholders to also review its 6-K filing for the quarter ended June 30, 2020, as filed with the United States Securities and Exchange Commission.




Note on International Financial Reporting Standards (IFRS)

Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.




Conference Call and Webcast Information

Affimed will host a conference call and webcast today, Tuesday, August 11, 2020 at 8:30 a.m. EDT to discuss second quarter 2020 financial results and recent corporate developments. The conference call will be available via phone and webcast.

To access the call, please dial +1 (646) 741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference passcode 8855368 approximately 15 minutes prior to the call.

A live audio webcast of the conference call will be available in the ?Webcasts? section on the ?Investors? page of the Affimed website at https://www.affimed.com/investors/webcasts_cp/. A replay of the webcast will be accessible at the same link for 30 days following the call.



About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer. Affimed?s fit-for-purpose ROCK® platform allows innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and into a Phase 1/2a dose escalation/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. For more information, please visit www.affimed.com.



Forward-Looking  

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