Mga Batayang Estadistika
| LEI | 5493004V4FSXT1D04610 |
| CIK | 1608390 |
SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis.
These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to Affimed N.V.
SEC Filings (Chronological Order)
Halaman ini menyediakan daftar lengkap dan kronologis dari Pengajuan SEC, tidak termasuk pengajuan kepemilikan yang kami sediakan di tempat lain.
| July 21, 2025 |
Delisting Determination, The Nasdaq Stock Market, LLC, July 11, 2025, Affimed N.V. The Nasdaq Stock Market LLC (the Exchange) has determined to remove from listing the security of Affimed N.V. effective at the opening of the trading session on July 31, 2025. Based on review of information provided by the Company, Nasdaq Staff determined that the Company no longer qualified for listing on the Excha |
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| May 14, 2025 |
Affimed Announces Receipt of Nasdaq Delisting Notice Exhibit 99.1 PRESS RELEASE Affimed Announces Receipt of Nasdaq Delisting Notice Mannheim, Germany, May 14, 2025 – 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 received a written notice from the staff of the Nasdaq Listing Qualifications Department (the “Staff”) notifying the |
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| May 14, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of May 2025 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2 68165 Mannheim, Germany (Address of principal executive offices) Indicate by check mark whether the registrant fil |
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| May 13, 2025 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of May 2025 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2 68165 Mannheim, Germany (Address of principal executive offices) Indicate by check mark whether the registrant |
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| May 13, 2025 |
Affimed Announces Filing for the Opening of Insolvency Proceedings Exhibit 99.1 PRESS RELEASE Affimed Announces Filing for the Opening of Insolvency Proceedings Mannheim, Germany, May 13, 2025 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced its decision to file an application for opening of insolvency proceedings with the local court of Mannheim in Germ |
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| May 1, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 12b-25 NOTIFICATION OF LATE FILING SEC File Number: 001-36619 CUSIP Number: N01045207 (Check one): ☐ Form 10-K ☒ Form 20-F ☐ Form 11-K ☐ Form 10-Q ☐ Form 10-D ☐ Form N-SAR ☐ Form N-CSR For Period Ended: December 31, 2024 ☐ Transition Report on Form 10-K ☐ Transition Report on Form 20-F ☐ Transition Report on Form 11 |
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| April 21, 2025 |
Affimed Announces Receipt of NASDAQ Deficiency Notice Regarding Minimum Bid Price Requirement Exhibit 99.1 PRESS RELEASE Affimed Announces Receipt of NASDAQ Deficiency Notice Regarding Minimum Bid Price Requirement Mannheim, Germany, April 21, 2025 – 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 received a written notice (the “Notice”), dated April 15, 2025, from the |
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| April 21, 2025 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of April 2025 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2 68165 Mannheim, Germany (Address of principal executive offices) Indicate by check mark whether the registra |
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| December 17, 2024 |
EX-99.1 Exhibit 99.1 PRESS RELEASE Affimed Reports Positive Clinical Update on AFM24/Atezolizumab Combination Therapy in Non-Small Cell Lung Cancer (NSCLC) • In 33 heavily pretreated NSCLC EGFR wild-type (EGFRwt) patients the combination of AFM24 and atezolizumab shows an overall response rate (ORR) of 21% (6 confirmed responses, 1 response awaiting confirmatory scan) and a disease control rate (D |
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| December 17, 2024 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of December, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the regi |
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| November 14, 2024 |
AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Exhibit 99.2 AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited condensed consolidated interim financial statements for the three and |
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| November 14, 2024 |
Affimed Reports Third Quarter 2024 Financial Results & Business Update Exhibit 99.3 PRESS RELEASE Affimed Reports Third Quarter 2024 Financial Results & Business Update • AFM24 combination with atezolizumab: The non-small cell lung cancer (NSCLC) EGFR wild-type (EGFRwt) cohort completed enrollment: Objective response rate (ORR) and safety data to be presented on a Company conference call on December 17, 2024. • Acimtamig (AFM13) combination with AlloNK® (AB-101): Upd |
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| November 14, 2024 |
Exhibit 99.1 Affimed N.V. Unaudited consolidated interim statements of comprehensive loss (in € thousand) For the three months ended September 30 For the nine months ended September 30 Note 2024 2023 2024 2023 Revenue 3 155 1,962 464 7,862 Other income and expenses – net 9 (6 ) 242 1,121 Research and development expenses (10,136 ) (21,498 ) (37,254 ) (76,302 ) General and administrative expenses ( |
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| November 14, 2024 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of November, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the regi |
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| November 8, 2024 |
Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim, Germany November 8, 2024 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim, Germany November 8, 2024 VIA EDGAR Submission United States Securities and Exchange Commission Division of Corporate Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Affimed N.V. Registration Statement on Form F-3 Filed November 4, 2024 CIK No. 0001608390 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of |
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| November 8, 2024 |
Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-282978 PROSPECTUS SUPPLEMENT (To Prospectus dated November 8, 2024) $20,000,000 Common Shares We have previously entered into an Open Market Sale AgreementSM, or sale agreement, with Jefferies LLC, or Jefferies, dated November 10, 2021, relating to the sale of our common shares offered by this prospectus supplement. In accorda |
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| November 4, 2024 |
As filed with the Securities and Exchange Commission on November 4, 2024 Table of Contents As filed with the Securities and Exchange Commission on November 4, 2024 Registration No. |
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| November 4, 2024 |
Exhibit 107 Calculation of Filing Fee Table Form S-3 (Form Type) AFFIMED N.V. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered Proposed Maximum Offering Price Per Unit Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee |
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| November 4, 2024 |
Exhibit 4.1 ARTICLES OF ASSOCIATION of: Affimed N.V. with corporate seat in Amsterdam dated 1 July 2024 Chapter 1 Definitions. Article 1. In the articles of association the following terms shall have the meaning as defined below: annual accounts : the annual accounts referred to in section 2:361 CC; annual statement of accounts : the annual accounts and, if applicable, the management report as wel |
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| October 24, 2024 |
AFMD / Affimed N.V. / 683 Capital Management, LLC - 683 CAPITAL MANAGEMENT, LLC Passive Investment SC 13G 1 afmd102424.htm 683 CAPITAL MANAGEMENT, LLC UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 Affimed N.V. (Name of Issuer) Common Shares, nominal value 0.01 per share (Title of Class of Securities) N01045207 (CUSIP Number) October 14, 2024 (Date of Event which Requires Filing of this Statement) Check the appropri |
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| October 15, 2024 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of October, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the regis |
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| September 11, 2024 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of September, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the reg |
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| September 11, 2024 |
EX-99.1 Exhibit 99.1 Text advertisement convocation EGM 2024 “Shareholders of Affimed N.V. are invited to attend an extraordinary general meeting of the company which will be held on October 10, 2024 at 13:00 hrs. (CET) at the offices of De Brauw Blackstone Westbroek N.V., Burgerweeshuispad 201, 1076 GR Amsterdam, the Netherlands. The record date for the meeting is September 12, 2024. The agenda w |
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| September 11, 2024 |
EX-99.2 Exhibit 99.2 AGENDA AND EXPLANATORY NOTES EXTRAORDINARY GENERAL MEETING OF AFFIMED N.V. to be held on Thursday October 10, 2024, starting at 13:00 hrs. (CET), at the offices of De Brauw Blackstone Westbroek N.V., Burgerweeshuispad 201, 1076 GR Amsterdam, the Netherlands (the “EGM”) Agenda 1. Opening Non-Voting 2. Appointment of Mr. Shawn Leland as a managing director Voting item 3. Approva |
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| September 11, 2024 |
POWER OF ATTORNEY EXTRAORDINARY GENERAL MEETING AFFIMED N.V. October 10, 2024 (FOR LEGAL ENTITY) EX-99.3 Exhibit 99.3 POWER OF ATTORNEY EXTRAORDINARY GENERAL MEETING AFFIMED N.V. October 10, 2024 (FOR LEGAL ENTITY) [insert full name], a legal entity organized and existing under the laws of [insert country], with its seat in [insert name city], having its offices in [insert address] (the “Grantor”) herewith grants a power of attorney to (please check the box that is applicable): ☐ (possibility |
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| September 5, 2024 |
Exhibit 99.1 Affimed N.V. Unaudited consolidated interim statements of comprehensive loss (in € thousand) For the three months ended For the six months ended June 30 June 30 Note 2024 2023 2024 2023 Revenue 3 154 1,390 309 5,900 Other income – net 56 717 233 1,127 Research and development expenses (11,727) (25,273) (27,118) (54,804) General and administrative expenses (4,036) (6,276) (8,512) (13,1 |
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| September 5, 2024 |
AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Exhibit 99.2 AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited condensed consolidated interim financial statements for the three and |
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| September 5, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of September, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the registr |
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| September 5, 2024 |
Exhibit 99.3 PRESS RELEASE Affimed Reports Second Quarter 2024 Financial Results & Business Update ● AFM24 combination with atezolizumab: 24 patients treated in the EGFR mutant (EGFRmut) non-small cell lung cancer (NSCLC) cohort; in 17 response-evaluable patients: 1 complete response (CR), 3 partial responses (PRs) and 8 stable diseases (SDs) were reported. Objective response rate (ORR) is 23.5% ( |
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| September 3, 2024 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of September, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the reg |
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| September 3, 2024 |
Affimed Appoints Shawn M. Leland as Chief Executive Officer EX-99.1 Exhibit 99.1 PRESS RELEASE Affimed Appoints Shawn M. Leland as Chief Executive Officer Mannheim, Germany, September 3, 2024 – Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that Shawn M. Leland, PharmD, RPh has been appointed as Chief Executive Officer |
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| June 26, 2024 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of June, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the registra |
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| June 12, 2024 |
AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS EX-99.2 Exhibit 99.2 AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited condensed consolidated interim financial statements as of Marc |
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| June 12, 2024 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of June, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the registra |
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| June 12, 2024 |
EX-99.1 Exhibit 99.1 Affimed N.V. Unaudited consolidated statements of comprehensive loss (in € thousand) For the three months ended March 31 Note 2024 2023 Revenue 3 155 4,510 Other income – net 177 410 Research and development expenses (15,391 ) (29,531 ) General and administrative expenses (4,476 ) (6,850 ) Operating loss (19,535 ) (31,461 ) Finance income / (costs) – net 4 360 (519 ) Loss befo |
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| June 12, 2024 |
EX-99.3 Exhibit 99.3 PRESS RELEASE Affimed Reports First Quarter 2024 Financial Results & Business Update - Initial data from the LuminICE-203 study shows 85.7% overall response rate (ORR) (6 of 7 patients); 4 out of 7 patients with complete response (CR) - - AFM28 shows single agent efficacy with 2 CR/CRi and 3 stable disease (SD) in 6 patients treated at dose level of 300 mg weekly - • Acimtami |
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| June 6, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K/A (Amendment No. 1) Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of June, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whet |
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| June 6, 2024 |
Exhibit 99.4 AGENDA AND EXPLANATORY NOTES 2024 ANNUAL GENERAL MEETING OF AFFIMED N.V. to be held on Wednesday June 26, 2024, starting at 09:00 hrs. (CET), at the offices of De Brauw Blackstone Westbroek N.V., Burgerweeshuispad 201, 1076 GR Amsterdam, the Netherlands Agenda 1. Opening Non-Voting 2. Report by the Management Board for the financial year 2023 Non-Voting 3. Adoption of the Statutory An |
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| June 3, 2024 |
EX-99.1 Exhibit 99.1 PRESS RELEASE Affimed Provides Follow-up Data of AFM24 plus Atezolizumab Showing Durable Responses in Heavily Pretreated NSCLC EGFR Wild-type Patients and Positive Initial Data from the NSCLC EGFR Mutant Cohort • In 17 EGFR wild-type (EGFRwt) non-small cell lung cancer (NSCLC) patients who failed chemotherapy and PD-1/PD-L1, AFM24 plus atezolizumab achieved 4 objective respons |
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| June 3, 2024 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of June, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the registra |
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| May 28, 2024 |
Exhibit 99.4 AGENDA AND EXPLANATORY NOTES 2024 ANNUAL GENERAL MEETING OF AFFIMED N.V. to be held on Wednesday June 26, 2024, starting at 09:00 hrs. (CET), at the offices of De Brauw Blackstone Westbroek N.V., Burgerweeshuispad 201, 1076 GR Amsterdam, the Netherlands Agenda 1. Opening Non-Voting 2. Report by the Management Board for the financial year 2023 Non-Voting 3. Adoption of the Statutory An |
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| May 28, 2024 |
Form 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of May, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the regi |
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| May 28, 2024 |
Text advertisement convocation AGM 2024 Exhibit 99.3 Text advertisement convocation AGM 2024 “Shareholders of Affimed N.V. are invited to attend the annual general meeting which will be held on June 26, 2024 at at 09:00 hrs. (CET) at the offices of De Brauw Blackstone Westbroek N.V., Burgerweeshuispad 201, 1076 GR Amsterdam, the Netherlands. The record date for the meeting is May 29, 2024. The agenda with explanatory notes and the proce |
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| May 28, 2024 |
Affimed Announces Annual General Meeting of Shareholders Exhibit 99.1 PRESS RELEASE Affimed Announces Annual General Meeting of Shareholders Mannheim, Germany, May 28, 2024 – Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that its 2024 Annual General Meeting of Shareholders (the “Annual Meeting”) will be held on Ju |
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| May 28, 2024 |
POWER OF ATTORNEY AGM AFFIMED N.V. JUNE 26, 2024 (FOR LEGAL ENTITY) Exhibit 99.5 POWER OF ATTORNEY AGM AFFIMED N.V. JUNE 26, 2024 (FOR LEGAL ENTITY) [insert full name], a legal entity organized and existing under the laws of [insert country], with its seat in [insert name city], having its offices in [insert address] (the “Grantor”) herewith grants a power of attorney to (please check the box that is applicable): ☐ (possibility to include name of an authorized per |
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| May 28, 2024 |
Invitation Annual General Meeting of Shareholders Affimed N.V Exhibit 99.2 Invitation Annual General Meeting of Shareholders Affimed N.V Mannheim, Germany May 28, 2024 Dear Shareholder, On behalf of Affimed N.V. (the “Company”), I invite you to attend the Annual General Meeting of Shareholders to be held on Wednesday June 26, 2024 (the “AGM”). The meeting will be held at the offices of De Brauw Blackstone Westbroek N.V., Burgerweeshuispad 201, 1076 GR Amster |
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| May 23, 2024 |
EX-99.1 Exhibit 99.1 PRESS RELEASE Affimed Announces Positive Early Efficacy and Progression Free Survival Results of AFM24-102 Study in EGFR Wild-Type Non-Small Cell Lung Cancer at the Annual Meeting of the American Society of Clinical Oncology 2024 • In 15 response-evaluable patients with metastatic EGFR wild-type NSCLC, who were pretreated with platinum doublet chemotherapy and checkpoint inhib |
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| May 23, 2024 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of May, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the registran |
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| March 28, 2024 |
EXHIBIT 12.2 CERTIFICATION I, Andreas Harstrick, certify that: 1. I have reviewed this annual report on Form 20-F of Affimed N.V.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to th |
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| March 28, 2024 |
English Summary of a lease agreement dated September 28, 2021 (the EXHIBIT 4.1 English Summary of a lease agreement dated September 28, 2021 (the Lease) by and between the ASG AcquiCo XXVI B. V. (the Landlord) and Affimed GmbH (the Tenant), as amended by supplement to the Lease dated September 5, 2022. Leased Property: the Tenant leases from the Landlord premises (the Premises) of 4,706 square meters of office and laboratory spaces, 614 square meters of storage s |
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| March 28, 2024 |
EXHIBIT 13.1 CERTIFICATION The certification set forth below is being submitted in connection with Affimed N.V.’s Annual Report on Form 20-F for the fiscal year ended December 31, 2023 (the “Report”) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code. And |
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| March 28, 2024 |
ARTICLES OF ASSOCIATION Affimed N.V. with corporate seat in Amsterdam dated 8 March 2024 EXHIBIT 1.1 ARTICLES OF ASSOCIATION of: Affimed N.V. with corporate seat in Amsterdam dated 8 March 2024 Chapter 1 Definitions. Article 1. In the articles of association the following terms shall have the meaning as defined below: annual accounts : the annual accounts referred to in section 2:361 CC; annual statement of accounts : the annual accounts and, if applicable, the management report as we |
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| March 28, 2024 |
Affimed Reports 2023 Financial Results and Operational Progress Exhibit 99.1 PRESS RELEASE Affimed Reports 2023 Financial Results and Operational Progress • AFM24 combination with atezolizumab (AFM24-102): Follow-up of the Phase 1/2a combination study confirmed four responses in the non-small cell cancer (NSCLC) EGFR-wildtype cohort: one complete response (CR), three partial responses (PR), and seven stable disease patients in the 15 heavily pretreated patient |
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| March 28, 2024 |
EXHIBIT 13.2 CERTIFICATION The certification set forth below is being submitted in connection with Affimed N.V.’s Annual Report on Form 20-F for the fiscal year ended December 31, 2023 (the “Report”) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code. And |
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| March 28, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of March, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the registrant |
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| March 28, 2024 |
EXHIBIT 97.1 Version:01 Page 1 of 7 CLAWBACK POLICY Code: Effective Date: 21.06.2023 CLAWBACK POLICY AFFIMED N.V. Approved by the Supervisory Board on 21.06.2023 Version:01 Page 2 of 7 CLAWBACK POLICY Code: Effective Date: 21.06.2023 Table of contents 1 PURPOSE 3 2 ADMINISTRATION 3 3 COVERED EXECUTIVES 3 4 RECOUPMENT; ACCOUNTING RESTATEMENT 3 5 INCENTIVE-BASED COMPENSATION 4 6 OVERPAYMENT: AMOUNT |
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| March 28, 2024 |
EXHIBIT 2 Description of rights of each applicable class of securities registered under Section 12 of the Securities Exchange Act of 1934 As of December 31, 2023, Affimed N. |
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| March 28, 2024 |
EXHIBIT 12.1 CERTIFICATION I, Andreas Harstrick, certify that: 1. I have reviewed this annual report on Form 20-F of Affimed N.V.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to th |
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| March 28, 2024 |
Consent of Independent Registered Public Accounting Firm EXHIBIT 15.1 Consent of Independent Registered Public Accounting Firm We consent to the incorporation by reference in the registration statements on Form S-8 (No. 333-198812 and 333-270798) and Form F-3 (No. 333-260946) of our reports dated March 28, 2024, with respect to the consolidated financial statements of Affimed N.V. and the effectiveness of internal control over financial reporting. /s/ K |
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| March 28, 2024 |
EXHIBIT 4.7 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH “[*****]”. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO AFFIMED IF DISCLOSED. EXECUTION VERSION COLLABORATION AGREEMENT This COLLABORATION AGREEMENT (this “Agreement”), made as of November 1, 2022 (the “Effec |
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| March 28, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 20-F Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report Commission file number: 001-36619 AFFIMED N. |
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| March 11, 2024 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of March, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the registr |
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| March 6, 2024 |
Affimed Announces 1-for-10 Reverse Stock Split EX-99.1 Exhibit 99.1 PRESS RELEASE Affimed Announces 1-for-10 Reverse Stock Split Mannheim, Germany, March 6, 2024 – Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced that the Company, with prior approval of the Company’s supervisory board and management board, intends |
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| March 6, 2024 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of March, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the registr |
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| February 14, 2024 |
AFMD / Affimed N.V. / Ridgeback Capital Investments L.P. - SC 13G/A Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G (Amendment No. |
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| February 13, 2024 |
AFMD / Affimed N.V. / 683 Capital Management, LLC - 683 CAPITAL MANAGEMENT, LLC Passive Investment SC 13G/A 1 afmda221424.htm 683 CAPITAL MANAGEMENT, LLC UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 2)* Affimed N.V. (Name of Issuer) Common Shares, nominal value 0.01 per share (Title of Class of Securities) N01045108 (CUSIP Number) December 31, 2023 (Date of Event which Requires Filing of this Statem |
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| January 8, 2024 |
EX-99.1 Exhibit 99.1 PRESS RELEASE Affimed Provides Clinical Response Update on AFM24-102 Trial in EGFR-wildtype Non-Small Cell Lung Cancer • Data update from AFM24-102 Phase 1/2a combination study includes 15 heavily pre-treated patients from the EGFR-wildtype (wt) non-small cell lung cancer (NSCLC) expansion cohort • Follow-up shows three of the initially reported responses have now been confirm |
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| January 8, 2024 |
Affimed Announces Leadership Change and Organizational Restructuring Exhibit 99.2 PRESS RELEASE Affimed Announces Leadership Change and Organizational Restructuring • Dr. Adi Hoess to step down as CEO and Management Board Member • Dr. Andreas Harstrick appointed Interim CEO • Strategic restructuring reducing headcount by up to 50%, extending cash runway into H2 2025 • Go forward organization will focus on advancing clinical programs • Company confirms guidance on d |
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| January 8, 2024 |
Affimed Announces Sale of Wholly-Owned Subsidiary AbCheck Exhibit 99.1 PRESS RELEASE Affimed Announces Sale of Wholly-Owned Subsidiary AbCheck Mannheim, Germany, January 3, 2024 – Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that it has reached a definitive agreement to sell its wholly-owned subsidiary, AbCheck s.r |
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| January 8, 2024 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of January, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the regis |
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| January 8, 2024 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of January, 2024 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the regis |
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| December 11, 2023 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of December, 2023 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim, Germany (Address of principal executive offices) Indicate by check mark whether the reg |
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| December 11, 2023 |
Exhibit 99.1 PRESS RELEASE Affimed Announces Positive Data for AFM24 in Combination with the PD-L1 Checkpoint Inhibitor Atezolizumab in Heavily Pre-treated EGFR-Wildtype Non-Small Cell Lung Cancer Patients • Data update from AFM24-102 Phase 1/2a combination study includes 15 heavily pre-treated patients from the EGFR-wildtype non-small cell lung cancer (NSCLC) expansion cohort • Responses observed |
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| December 11, 2023 |
EX-99.2 Exhibit 99.2 PRESS RELEASE Affimed Announces Updated Phase 1/2 Data from Acimtamig in Combination with Allogeneic NK in Hodgkin Lymphoma Patients Who Failed Prior Chemotherapy and Are Double-Refractory to Brentuximab Vedotin (BV) and Checkpoint Inhibitors (CPIs) • In 32 patients with relapsed/refractory (r/r) Hodgkin lymphoma (HL) treated at the recommended phase 2 dose level (RP2D), the o |
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| November 30, 2023 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of November, 2023 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the regi |
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| November 14, 2023 |
EX-99.1 Exhibit 99.1 Affimed N.V. Unaudited consolidated interim statements of comprehensive loss (in € thousand) For the three months ended September 30 For the nine months ended September 30 Note 2023 2022 2023 2022 Revenue 3 1,962 14,888 7,862 30,195 Other income – net (6 ) 118 1,121 642 Research and development expenses (21,498 ) (26,126 ) (76,302 ) (65,333 ) General and administrative expense |
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| November 14, 2023 |
AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS EX-99.2 Exhibit 99.2 AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited condensed consolidated interim financial statements for the th |
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| November 14, 2023 |
Affimed Reports Third Quarter 2023 Financial Results and Highlights Operational Progress EX-99.3 Exhibit 99.3 PRESS RELEASE Affimed Reports Third Quarter 2023 Financial Results and Highlights Operational Progress • Acimtamig (also known as AFM13) combination with AlloNK® (also known as AB-101): Initiated LuminICE-203. Company on track to report initial data in H1 2024. • Acimtamig: Received fast-track designation for the combination of acimtamig and AlloNK®. • LuminICE-203: received e |
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| November 14, 2023 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of November, 2023 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Indicate by check mark whether the regi |
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| October 4, 2023 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of October, 2023 Commission File Number: 001-36619 Affimed N.V. Gottlieb-Daimler-Straße 2, 68165 Mannheim Germany (Address of principal executive offices) Im Neuenheimer Feld 582, 69120 Heidelber |
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| October 4, 2023 |
Affimed Announces Listing Transfer to NASDAQ Capital Markets EX-99.1 Exhibit 99.1 PRESS RELEASE Affimed Announces Listing Transfer to NASDAQ Capital Markets Mannheim, Germany, October 4, 2023 – Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that it has received approval from the Listing Qualifications Department of the |
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| August 10, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of August, 2023 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registran |
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| August 10, 2023 |
Affimed Reports Second Quarter 2023 Financial Results and Highlights Operational Progress Exhibit 99.3 PRESS RELEASE Affimed Reports Second Quarter 2023 Financial Results and Highlights Operational Progress ● AFM13 combination with AB-101 NK cells (LuminICE-203): On track to report initial efficacy and safety data in the first half 2024; Type C meeting request submitted to FDA to clarify requirements for accelerated approval. ● AFM24 monotherapy: Clinical activity in 7 out of 15 heavil |
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| August 10, 2023 |
AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Exhibit 99.2 AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited condensed consolidated interim financial statements for the three and |
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| August 10, 2023 |
Exhibit 99.1 Affimed N.V. Unaudited consolidated interim statements of comprehensive loss (in € thousand) For the three months ended For the six months ended June 30 June 30 Note 2023 2022 2023 2022 Revenue 3 1,390 7,301 5,900 15,307 Other income – net 717 240 1,127 524 Research and development expenses (25,273) (20,829) (54,804) (39,208) General and administrative expenses (6,276) (8,374) (13,126 |
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| June 22, 2023 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of June, 2023 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registr |
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| June 22, 2023 |
Affimed Announces Addition of Dr. Constanze Ulmer-Eilfort to its Supervisory Board EX-99.1 Exhibit 99.1 PRESS RELEASE Affimed Announces Addition of Dr. Constanze Ulmer-Eilfort to its Supervisory Board Heidelberg, Germany, June 22, 2023 – Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the appointment of Dr. Constanze Ulmer-Eilfort to its Sup |
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| June 5, 2023 |
EX-99.1 Exhibit 99.1 PRESS RELEASE Affimed Presents AFM24 Monotherapy Data in Non-Small Cell Lung Cancer at the Annual Meeting of the American Society of Clinical Oncology and Provides Strategic Update on AFM24 Development Plan • Data update from AFM24-101 phase 1/2 monotherapy study includes 15 patients from the EGFR mutant non-small cell lung cancer (NSCLC) cohort • AFM24 showed clinical activit |
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| June 5, 2023 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of June, 2023 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registr |
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| May 23, 2023 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of May, 2023 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registra |
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| May 23, 2023 |
For the three months ended March 31 EX-99.1 Exhibit 99.1 Affimed N.V. Unaudited consolidated statements of comprehensive loss (in € thousand) For the three months ended March 31 Note 2023 2022 Revenue 3 4,510 8,006 Other income – net 410 284 Research and development expenses (29,531 ) (18,379 ) General and administrative expenses (6,850 ) (7,045 ) Operating loss (31,461 ) (17,134 ) Finance income / (costs) – net 4 (519 ) 471 Loss be |
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| May 23, 2023 |
Affimed Reports First Quarter 2023 Financial Results and Highlights Operational Progress EX-99.3 Exhibit 99.3 PRESS RELEASE Affimed Reports First Quarter 2023 Financial Results and Highlights Operational Progress • AFM13 combination with AB-101 NK cells: Received IND clearance from the FDA for a phase 2 clinical trial investigating the combination therapy in relapsed/refractory (r/r) classical Hodgkin Lymphoma (cHL) and peripheral T Cell Lymphoma (PTCL). Affimed expects to initiate cl |
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| May 23, 2023 |
AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS EX-99.2 Exhibit 99.2 AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited condensed consolidated interim financial statements for the th |
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| May 23, 2023 |
EX-99.4 Exhibit 99.4 PRESS RELEASE Affimed Announces IND Clearance for a Phase 2 Clinical Trial Investigating AFM13 and AB-101 Combination Therapy • Phase 2 combination study of AFM13 with AB-101 in relapsed or refractory (r/r) classical Hodgkin Lymphoma (cHL) will be an open-label, multi-center, multi-cohort study with a safety run-in followed by dose optimization and expansion phase • Primary en |
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| May 22, 2023 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of May, 2023 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registra |
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| May 22, 2023 |
POWER OF ATTORNEY AGM AFFIMED N.V. JUNE 21, 2023 (FOR LEGAL ENTITY) EX-99.5 Exhibit 99.5 POWER OF ATTORNEY AGM AFFIMED N.V. JUNE 21, 2023 (FOR LEGAL ENTITY) [insert full name], a legal entity organized and existing under the laws of [insert country], with its seat in [insert name city], having its offices in [insert address] (the “Grantor”) herewith grants a power of attorney to (please check the box that is applicable): ☐ (possibility to include name of an author |
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| May 22, 2023 |
Text advertisement convocation AGM 2023 EX-99.3 Exhibit 99.3 Text advertisement convocation AGM 2023 “Shareholders of Affimed N.V. are invited to attend the annual general meeting which will be held on June 21, 2023 at 14:00 hrs. CET at the NH Collection Amsterdam Barbizon Palace, Prins Hendrikkade 59-72, 1012 AD Amsterdam, the Netherlands. The record date for the meeting is May 24, 2023. The agenda with explanatory notes and the proced |
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| May 22, 2023 |
Invitation Annual General Meeting of Shareholders Affimed N.V EX-99.2 Exhibit 99.2 Invitation Annual General Meeting of Shareholders Affimed N.V Heidelberg, May 22, 2023 Dear Shareholder, On behalf of Affimed N.V. (the “Company”), I invite you to attend the Annual General Meeting of Shareholders to be held on Wednesday June 21, 2023 (the “AGM”). The meeting will be held at the NH Collection Amsterdam Barbizon Palace, Prins Hendrikkade 59-72, 1012 AD Amsterda |
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| May 22, 2023 |
Affimed Announces Annual General Meeting of Shareholders EX-99.1 Exhibit 99.1 PRESS RELEASE Affimed Announces Annual General Meeting of Shareholders Heidelberg, Germany, May 22, 2023 – Affimed N.V. (Nasdaq: AFMD) (“Affimed”, or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that its 2023 Annual General Meeting of Shareholders (the “Annual Meeting”) will be |
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| May 22, 2023 |
EX-99.4 Exhibit 99.4 ANNUAL GENERAL MEETING OF SHAREHOLDERS AFFIMED N.V. to be held on Wednesday, 21 June 2023 at 14:00 hrs. (CET) at the NH Collection Amsterdam Barbizon Palace, Prins Hendrikkade 59-72, 1012 AD Amsterdam, the Netherlands Agenda 1. Opening Non-Voting 2. Report by the Management Board for the financial year 2022 Non-Voting 3. Adoption of the Statutory Annual Accounts for the financ |
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| April 6, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of April, 2023 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registrant |
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| April 6, 2023 |
Affimed Announces Receipt of NASDAQ Deficiency Notice Regarding Minimum Bid Price Requirement EX-99.1 Exhibit 99.1 PRESS RELEASE Affimed Announces Receipt of NASDAQ Deficiency Notice Regarding Minimum Bid Price Requirement Heidelberg, Germany, April 6, 2023 – 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 received a written notice (the “Notice”), dated April 4, 2023, f |
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| March 23, 2023 |
424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-260946 PROSPECTUS SUPPLEMENT (To Prospectus dated April 6, 2022) $100,000,000 Common Shares We have previously entered into an Open Market Sale AgreementSM, or sale agreement, with Jefferies LLC, or Jefferies, dated November 10, 2021, relating to the sale of our common shares offered by this prospectus supplement. In acc |
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| March 23, 2023 |
EXHIBIT 13.2 CERTIFICATION The certification set forth below is being submitted in connection with Affimed N.V.’s Annual Report on Form 20-F for the fiscal year ended December 31, 2022 (the “Report”) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code. Ang |
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| March 23, 2023 |
Affimed Reports 2022 Financial Results and Operational Progress EX-99.1 Exhibit 99.1 PRESS RELEASE Affimed Reports 2022 Financial Results and Operational Progress • AFM13 combination with AB-101 NK cells: On track for IND filing in H1 2023 and initiation of clinical study in 2023 • AFM13 monotherapy REDIRECT data: Oral presentation at the AACR annual meeting • AFM24: Data from the three ongoing studies expected to be presented at scientific conferences in Q2 o |
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| March 23, 2023 |
Certification of Principal Executive Officer pursuant to 17 CFR 240.13a-14(a). EXHIBIT 12.1 CERTIFICATION I, Adi Hoess, certify that: 1. I have reviewed this annual report on Form 20-F of Affimed N.V.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period |
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| March 23, 2023 |
EXHIBIT 4.9 COLLABORATION AGREEMENT This COLLABORATION AGREEMENT (this “Agreement”), made as of November 1, 2022 (the “Effective Date”), is by and between AFFIMED GMBH, a German corporation (“Affimed”), having a primary place of business at Im Neuenheimer Feld 582, 69120 Heidelberg, Germany, and ARTIVA BIOTHERAPEUTICS, INC., a Delaware corporation (“Artiva”), having a primary place of business at |
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| March 23, 2023 |
Certification of Principal Executive Officer pursuant to 17 CFR 240.13a-14(b) and 18 U.S.C. 1350. EXHIBIT 13.1 CERTIFICATION The certification set forth below is being submitted in connection with Affimed N.V.’s Annual Report on Form 20-F for the fiscal year ended December 31, 2022 (the “Report”) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code. Adi |
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| March 23, 2023 |
Certification of Principal Financial and Accounting Officer pursuant to 17 CFR 240.13a-14(a). EXHIBIT 12.2 CERTIFICATION I, Angus W. Smith, certify that: 1. I have reviewed this annual report on Form 20-F of Affimed N.V.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the p |
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| March 23, 2023 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of March, 2023 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the regist |
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| March 23, 2023 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022. |
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| March 23, 2023 |
Power of Attorney (included on the signature page hereto) S-8 As filed with the Securities and Exchange Commission on March 23, 2023 Registration No. |
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| March 23, 2023 |
EX-FILING FEES 4 d478346dexfilingfees.htm EX-FILING FEES EXHIBIT 107 Calculation Of Filing Fee Tables Form S-8 (Form Type) Affimed N.V. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1) Proposed Maximum Offering Price Per Share Maximum Aggregate Offering Price Fee Rate Amount of R |
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| March 23, 2023 |
Exhibit 2 Description of rights of each applicable class of securities registered under Section 12 of the Securities Exchange Act of 1934 As of December 31, 2022, Affimed N. |
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| March 23, 2023 |
Consent of KPMG AG Wirtschaftsprüfungsgesellschaft Exhibit 15.1 Consent of Independent Registered Public Accounting Firm We consent to the incorporation by reference in the registration statements on Form S-8 (No. 333-198812) and Form F-3 (No. 333-260946 and No. 333-251648) of our reports dated March 23, 2023, with respect to the consolidated statements of Affimed N.V. and the effectiveness of internal control over financial reporting. Mannheim, G |
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| February 14, 2023 |
EX-99.1 2 pt7213gab.htm JOINT FILING AGREEMENT Exhibit 99.1 JOINT FILING AGREEMENT The undersigned hereby agree that the foregoing statement on Schedule 13G is filed on behalf of each of the undersigned in accordance with the provisions of Rule 13d-1(k) under the Securities Exchange Act of 1934, as amended, and that all subsequent amendments to this statement on Schedule 13G may be filed on behalf |
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| February 14, 2023 |
SC 13G/A 1 pt7213gaa.htm SCHEDULE 13G/A, AMENDMENT #2 240.13d-102 Schedule 13G - Information to be included in statements filed pursuant to 240.13d-1(b), (c), and (d) and amendments thereto filed pursuant to 240.13d-2. Securities and Exchange Commission, Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No. 2)* (Name of Issuer) Affimed N.V. (Title of Class of |
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| February 14, 2023 |
AFMD / Affimed N.V. / Ridgeback Capital Investments L.P. - SCHEDULE 13G/A Passive Investment SC 13G/A 1 tm234702d2sc13ga.htm SCHEDULE 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G (Amendment No. 2) UNDER THE SECURITIES EXCHANGE ACT OF 19341 Affimed N.V. (Name of Issuer) Common Shares (Title of Class of Securities) N01045108 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to design |
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| February 14, 2023 |
AFMD / Affimed N.V. / Ridgeback Capital Investments L.P. - SCHEDULE 13G/A Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G (Amendment No. |
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| February 14, 2023 |
SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G (RULE 13d - 102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO 13d-1(b), (c) AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO 13d-2(b) (Amendment No. 1)* Affimed N.V. (Name of Issuer) Common Shares, nominal value €0.01 per share (Title of Class of Securities) N01045108 (CUSIP Number) December 31, 2022 (Date of Even |
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| January 9, 2023 |
Affimed Reports on Corporate Progress and Provides Regulatory Update for AFM13 Exhibit 99.1 PRESS RELEASE Affimed Reports on Corporate Progress and Provides Regulatory Update for AFM13 • AFM13 combination with Artiva’s AB-101 NK cells: Received written feedback to pre-investigational new drug (IND) meeting request which supports plan for IND filing in H1 2023 and initiation of clinical study during 2023 • AFM24: Data updates from the three AFM24 ongoing studies are expected |
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| January 9, 2023 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of January, 2023 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the regi |
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| December 12, 2022 |
EX-99.1 Exhibit 99.1 PRESS RELEASE Affimed Provides Updated Clinical Data from Phase 1/2 Study of AFM13 Precomplexed with Cord Blood-Derived NK Cells at the ASH 2022 Annual Meeting • AFM13 in combination with NK cells shows very high overall and complete response rates in 41 heavily pre-treated CD30-positive Hodgkin lymphoma (HL) and Non-Hodgkin lymphoma (NHL) patients • Patients had a median of s |
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| December 12, 2022 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of December, 2022 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the reg |
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| December 12, 2022 |
EX-99.2 3 d366116dex992.htm EX-99.2 Exhibit 99.2 Affimed Reports Topline Data from AFM13 Monotherapy Phase 2 REDIRECT Study in Patients with Relapsed or Refractory Peripheral T Cell Lymphoma • Data from REDIRECT establish that AFM13 monotherapy is effective in the treatment of relapsed/refractory peripheral T cell lymphoma (r/r PTCL) patients with a differentiated safety profile • AFM13 demonstrat |
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| November 15, 2022 |
EX-99.1 2 d412180dex991.htm EX-99.1 Exhibit 99.1 Affimed N.V. Unaudited consolidated interim statements of comprehensive income / (loss) (in € thousand) For the three months ended September For the nine months ended September Note 2022 2021 2022 2021 Revenue 3 14,888 8,662 30,195 30,028 Other income – net 118 231 642 710 Research and development expenses (26,126 ) (20,621 ) (65,333 ) (53,826 ) Gen |
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| November 15, 2022 |
EX-99.3 Exhibit 99.3 PRESS RELEASE Affimed Reports Third Quarter 2022 Financial Results and Highlights Recent Clinical and Corporate Progress • AFM13: Secured access to commercially viable natural killer (NK) cell product to accelerate clinical development of AFM13 and address the high unmet need of CD30-positive lymphoma patients through a collaboration with Artiva Biotherapeutics; an Investigati |
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| November 15, 2022 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of November, 2022 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the reg |
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| November 15, 2022 |
AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS EX-99.2 Exhibit 99.2 AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited condensed consolidated interim financial statements for the th |
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| November 3, 2022 |
EX-99.1 Exhibit 99.1 Affimed and Artiva Biotherapeutics Announce Partnership to Advance Combination Therapy of Innate Cell Engager (ICE®) AFM13 and Off-the-Shelf Allogeneic NK Cell Therapy AB-101 • Companies to combine their clinical programs (AFM13, AB-101) to address high unmet need of CD30-positive lymphoma patients • Affimed’s AFM13 in combination with cord blood-derived NK cells demonstrated |
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| November 3, 2022 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of November, 2022 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the reg |
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| August 11, 2022 |
Exhibit 99.1 ? AFFIMED N.V. Unaudited consolidated interim statements of comprehensive income / (loss) (in ? thousand) ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? For the three months ? For the six months ? ? ? ? ended June 30 ? ended June 30 ? Note 2022 2021 2022 2021 Revenue ? 3 ? 7,301 ? 9,707 ? 15,307 ? 21,366 ? ? ? ? ? ? ? ? ? ? ? Other income ? net ? 240 332 524 479 Research and development expenses ? ( |
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| August 11, 2022 |
Affimed Reports Second Quarter 2022 Financial Results and Highlights Recent Operational Progress Exhibit 99.3 PRESS RELEASE Affimed Reports Second Quarter 2022 Financial Results and Highlights Recent Operational Progress ? AFM13 monotherapy: On track to report topline data of the registration-directed REDIRECT trial in the fourth quarter of 2022 ? AFM13 combination with natural killer (NK) cells: On track to report updated data at a scientific conference in the fourth quarter of 2022 ? AFM24: |
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| August 11, 2022 |
? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K ? Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 ? For the month of August, 2022 ? Commission File Number: 001-36619 ? Affimed N.V. ? Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) ? Indicate by check mark wheth |
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| August 11, 2022 |
AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Exhibit 99.2 AFFIMED N.V. MANAGEMENT?S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This management?s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited condensed consolidated interim financial statements for the three and |
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| June 23, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of June, 2022 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registrant |
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| June 1, 2022 |
Affimed Reports First Quarter 2022 Financial Results and Highlights Recent Operational Progress Exhibit 99.3 PRESS RELEASE Affimed Reports First Quarter 2022 Financial Results and Highlights Recent Operational Progress ? AFM13 monotherapy: Completed enrollment in the REDIRECT study for patients with relapsed or refractory PTCL; on track to report topline data in the fourth quarter of 2022 ? AFM13 combination with NK cells: Reported data at AACR 2022 showing a 100% objective response rate (OR |
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| June 1, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of June, 2022 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registrant |
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| June 1, 2022 |
AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Exhibit 99.2 AFFIMED N.V. MANAGEMENT?S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This management?s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited condensed consolidated interim financial statements for the three-mont |
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| June 1, 2022 |
Exhibit 99.1 Affimed N.V. Unaudited consolidated statements of comprehensive income / (loss) (in ? thousand) For the three months ended March 31 Note 2022 2021 Revenue 3 8,006 11,659 Other income ? net 284 147 Research and development expenses (18,379 ) (11,405 ) General and administrative expenses (7,045 ) (4,486 ) Operating income / (loss) (17,134 ) (4,085 ) Finance income / (costs) ? net 4 471 |
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| May 24, 2022 |
Invitation Annual General Meeting of Shareholders Affimed N.V Exhibit 99.2 Invitation Annual General Meeting of Shareholders Affimed N.V Heidelberg, May 24, 2022 Dear Shareholder, On behalf of Affimed N.V. (the ?Company?), I invite you to attend the Annual General Meeting of Shareholders to be held on Wednesday June 22, 2022 (the ?AGM?). The meeting will be held at the Radisson Blu Hotel, Amsterdam City Center, Rusland 17, 1012 CK Amsterdam, the Netherlands. |
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| May 24, 2022 |
Text advertisement convocation AGM 2022 Exhibit 99.3 Text advertisement convocation AGM 2022 ?Shareholders of Affimed N.V. are invited to attend the annual general meeting which will be held on June 22, 2022 at 9:00 hrs. CET at the Radisson Blu Hotel, Amsterdam City Center, Rusland 17, 1012 CK Amsterdam, the Netherlands. The record date for the meeting is May 25, 2022. The agenda with explanatory notes and the procedure for attending th |
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| May 24, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of May, 2022 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registrant f |
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| May 24, 2022 |
Affimed Announces Annual General Meeting of Shareholders Exhibit 99.1 PRESS RELEASE Affimed Announces Annual General Meeting of Shareholders Heidelberg, Germany, May 24, 2022 ? Affimed N.V. (Nasdaq: AFMD) (?Affimed?, or the ?Company?), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that its 2022 Annual General Meeting of Shareholders (the ?Annual Meeting?) will be held on |
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| May 24, 2022 |
POWER OF ATTORNEY AGM AFFIMED N.V. JUNE 22, 2022 (FOR LEGAL ENTITY) Exhibit 99.5 POWER OF ATTORNEY AGM AFFIMED N.V. JUNE 22, 2022 (FOR LEGAL ENTITY) [insert full name], a legal entity organized and existing under the laws of [insert country], with its seat in [insert name city], having its offices in [insert address] (the ?Grantor?) herewith grants a power of attorney to (please check the box that is applicable): ? (possibility to include name of an authorized per |
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| May 24, 2022 |
Exhibit 99.4 ANNUAL GENERAL MEETING OF SHAREHOLDERS AFFIMED N.V. to be held on Wednesday, 22 June 2022 at 9:00 hrs. (CET) at the Radisson Blu Hotel, Amsterdam City Center, Rusland 17, 1012 CK Amsterdam, the Netherlands Agenda 1. Opening Non-Voting 2. Report by the Management Board for the financial year 2021 Non-Voting 3. Adoption of the Statutory Annual Accounts for the financial year 2021 Voting |
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| April 21, 2022 |
AFMD / Affimed N.V. / Gilde Healthcare Holding B.V. - SC 13G Passive Investment SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Affimed N.V. (Name of Issuer) Common Shares (Title of Class of Securities) N01045108 (CUSIP number) April 18, 2022 (Date of Event which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to which this Schedule is filed: ? Rule 1 |
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| April 21, 2022 |
JOINT FILING AGREEMENT PURSUANT TO RULE 13d-1(k)(1) Exhibit 1 JOINT FILING AGREEMENT PURSUANT TO RULE 13d-1(k)(1) The undersigned acknowledge and agree that the foregoing statement on Schedule 13G is filed on behalf of each of the undersigned and that all subsequent amendments to this statement on Schedule 13G shall be filed on behalf of each of the undersigned without the necessity of filing additional joint filing statements. |
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| April 18, 2022 |
EX-1.1 Exhibit 1.1 Affimed N.V. 22,500,000 Common Shares (Par Value €0.01 Per Share) UNDERWRITING AGREEMENT April 12, 2022 Jefferies LLC SVB Securities LLC Truist Securities, Inc. Wells Fargo Securities, LLC As Representatives of the several Underwriters c/o Jefferies LLC 520 Madison Avenue New York, New York 10022 c/o SVB Securities LLC 1301 Avenue of the Americas, 12th Floor New York, New York 1 |
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| April 18, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of April, 2022 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registrant |
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| April 14, 2022 |
22,500,000 Shares Common Shares 424B5 1 d303652d424b5.htm 424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-260946 PROSPECTUS SUPPLEMENT (To Prospectus dated April 6, 2022) 22,500,000 Shares Common Shares We are offering 22,500,000 common shares. Our common shares trade on The Nasdaq Global Market, or Nasdaq, under the trading symbol “AFMD.” On April 11, 2022, the last sale price of our common shares |
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| April 12, 2022 |
SUBJECT TO COMPLETION, DATED APRIL 12, 2022 Table of Contents The information in this preliminary prospectus is not complete and may be changed. |
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| April 11, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of April, 2022 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registrant |
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| April 11, 2022 |
Exhibit 99.2 PRESS RELEASE Affimed Presents Updated Clinical Data from Phase 1/2 Study of AFM13 Precomplexed with Cord Blood-Derived NK Cells at AACR Annual Meeting ? 100% objective response rate and improvement in the rate of complete responses (CR) from 38% to 62% after a second cycle in 13 patients treated at the recommended phase 2 dose (RP2D) ? Patients enrolled were multi-refractory with a m |
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| April 11, 2022 |
Exhibit 99.1 PRESS RELEASE Affimed Presents Findings from the Dose-escalation Phase of the First-in-human Study of AFM24 in Patients with EGFR-positive Solid Tumors ? The recommended phase 2 dose was determined at 480 mg ? AFM24 has demonstrated a well-managed safety profile ? Pharmacodynamic activity was observed at doses of 160 mg and higher ? The maximum tolerated dose was not reached and the d |
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| March 31, 2022 |
Table of Contents ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 20-F (Mark One) ? ? REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 ? OR ? ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ? For the fiscal year ended December 31, 2021. |
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| March 31, 2022 |
Exhibit 2 Description of rights of each applicable class of securities registered under Section 12 of the Securities Exchange Act of 1934 As of December 31, 2021, Affimed N. |
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| March 31, 2022 |
Certification of Principal Financial and Accounting Officer pursuant to 17 CFR 240.13a-14(a). EXHIBIT 12.2 CERTIFICATION I, Angus W. Smith, certify that: 1. I have reviewed this annual report on Form 20-F of Affimed N.V.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the p |
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| March 31, 2022 |
Affimed Reports 2021 Financial Results and Highlights Recent Operational Progress Exhibit 99.1 PRESS RELEASE Affimed Reports 2021 Financial Results and Highlights Recent Operational Progress ? Completed enrollment for AFM13-202 monotherapy study, REDIRECT, and on track to report topline data in the second half of 2022 ? Presented interim data in December 2021 of the combination study of AFM13 with NK cells (AFM13-104), showing 100% ORR after one treatment cycle at the highest N |
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| March 31, 2022 |
EXHIBIT 13.2 CERTIFICATION The certification set forth below is being submitted in connection with Affimed N.V.’s Annual Report on Form 20-F for the fiscal year ended December 31, 2021 (the “Report”) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code. Ang |
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| March 31, 2022 |
Certification of Principal Executive Officer pursuant to 17 CFR 240.13a-14(b) and 18 U.S.C. 1350. EXHIBIT 13.1 CERTIFICATION The certification set forth below is being submitted in connection with Affimed N.V.’s Annual Report on Form 20-F for the fiscal year ended December 31, 2021 (the “Report”) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Section 1350 of Chapter 63 of Title 18 of the United States Code. Adi |
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| March 31, 2022 |
As filed with the Securities and Exchange Commission on March 31, 2022 POS AM 1 d305899dposam.htm POS AM Table of Contents As filed with the Securities and Exchange Commission on March 31, 2022 Registration No. 333-260946 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 POST-EFFECTIVE AMENDMENT NO. 2 TO FORM F-3 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Affimed N.V. (Exact Name of Registrant as Specified in Its Charter) Not Applic |
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| March 31, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of March, 2022 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registrant |
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| March 31, 2022 |
Certification of Principal Executive Officer pursuant to 17 CFR 240.13a-14(a). EXHIBIT 12.1 CERTIFICATION I, Adi Hoess, certify that: 1. I have reviewed this annual report on Form 20-F of Affimed N.V.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period |
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| March 31, 2022 |
Exhibit 107 Calculation of Filing Fee Tables Form F-3 (Form Type) Affimed N.V. (Exact Name of Registrant as Specified in its Charter) Table 1: Newly Registered and Carry Forward Securities Security Type Security Class Title Fee Calculation or Carry Forward Rule Amount Registered(2) Proposed Maximum Offering Price Per Unit(3) Maximum Aggregate Offering Price Fee Rate Amount of Registration Fee Carr |
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| March 31, 2022 |
As filed with the Securities and Exchange Commission on March 31, 2022 Table of Contents As filed with the Securities and Exchange Commission on March 31, 2022 Registration No. |
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| March 31, 2022 |
Consent of KPMG AG Wirtschaftsprüfungsgesellschaft EX-15.1 7 afmd-20211231xex15d1.htm EXHIBIT 15.1 Exhibit 15.1 Consent of Independent Registered Public Accounting Firm We consent to the incorporation by reference in the registration statements on Form S-8 (No. 333-198812) and Form F-3 (No. 333-260946 and No. 333-251648) of our reports dated March 31, 2022, with respect to the consolidated statements of Affimed N.V. and the effectiveness of intern |
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| February 14, 2022 |
240.13d-102 Schedule 13G - Information to be included in statements filed pursuant to 240.13d-1(b), (c), and (d) and amendments thereto filed pursuant to 240.13d-2. Securities and Exchange Commission, Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* (Name of Issuer) Affimed N.V. (Title of Class of Securities) Common Shares, nominal value ?0.01 per sh |
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| February 14, 2022 |
AFMD / Affimed N.V. / Ridgeback Capital Investments L.P. - SC 13G/A Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G (Amendment No. |
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| February 7, 2022 |
AFMD / Affimed N.V. / 683 Capital Management, LLC - FEBRUARY 7,2022 Passive Investment SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 SCHEDULE 13G (RULE 13d - 102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO 13d-1(b), (c) AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO 13d-2(b) (Amendment No. )* Affimed N.V. (Name of Issuer) Common Shares, nominal value ?0.01 per share (Title of Class of Securities) N01045108 (CUSIP Number) January 28, 2022 (Date of Event |
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| January 6, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of January, 2022 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registra |
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| January 6, 2022 |
Exhibit 99.1 PRESS RELEASE 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 pati |
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| December 9, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of December, 2021 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registr |
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| December 9, 2021 |
Exhibit 99.1 PRESS RELEASE Affimed to Host Virtual Investor Call Today to Discuss Treatment of CD30-positive Lymphoma Patients with Cord Blood-derived Natural Killer Cells Pre-complexed with Innate Cell Engager AFM13 - For the 13 patients treated at the recommended phase 2 dose (RP2D) the response rate after one cycle of treatment remains at 100% with a 38.5% complete response (CR) rate; one addit |
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| November 22, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of November, 2021 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registr |
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| November 22, 2021 |
Exhibit 99.1 PRESS RELEASE Affimed Announces 100% Objective Response Rate at Highest Dose in Phase 1-2 Study of Cord Blood-derived Natural Killer Cells Pre-complexed with Innate Cell Engager AFM13 for CD30-positive Lymphomas ? 100% objective response rate with a 42% complete response rate in 12 patients, according to investigator assessment, after the 1st of 2 planned cycles at the recommended pha |
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| November 10, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of November, 2021 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registr |
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| November 10, 2021 |
Affimed Reports Third Quarter 2021 Financial Results and Highlights Operational Progress EX-99.3 4 d232713dex993.htm EX-99.3 Exhibit 99.3 PRESS RELEASE Affimed Reports Third Quarter 2021 Financial Results and Highlights Operational Progress • AFM13 monotherapy: Enrollment is on track and expected to be completed in the first half of 2022. • AFM13 combination with NK cells: Updated data to be presented at company-sponsored event in mid-December 2021. • AFM24 monotherapy: Identified rec |
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| November 10, 2021 |
EX-99.1 2 d232713dex991.htm EX-99.1 Exhibit 99.1 Affimed N.V. Unaudited interim consolidated statements of comprehensive income / (loss) (in € thousand) For the three months ended September 30, For the nine months ended September 30, Note 2021 2020 2021 2020 Revenue 3 8,662 10,545 30,028 18,614 Other income/(expenses) - net 231 102 710 130 Research and development expenses (20,621 ) (10,101 ) (53, |
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| November 10, 2021 |
AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Exhibit 99.2 AFFIMED N.V. MANAGEMENT?S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This management?s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited interim condensed consolidated financial statements for the three and |
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| November 10, 2021 |
Sale Agreement, dated as of November 10, 2021, among Affimed N.V. and Jefferies LLC Exhibit 1.2 OPEN MARKET SALE AGREEMENTSM November 10, 2021 JEFFERIES LLC 520 Madison Avenue New York, New York 10022 Ladies and Gentlemen: Affimed N.V., a company incorporated under the laws of the Netherlands (the ?Company?), proposes, subject to the terms and conditions stated herein, to issue and sell from time to time through Jefferies LLC, as sales agent and/or principal (the ?Agent?), shares |
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| November 10, 2021 |
Table of Contents As filed with the Securities and Exchange Commission on November 10, 2021 Registration No. |
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| September 8, 2021 |
AFFIMED N.V. UNAUDITED CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS Exhibits 99.1 AFFIMED N.V. UNAUDITED CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS Unaudited interim consolidated statements of comprehensive income / (loss) (in € thousand) For the three months For the six months ended June 30 ended June 30 Note 2021 2020 2021 2020 Revenue 3 9,707 2,934 21,366 8,069 Other income – net 332 85 479 28 Research and development expenses (21,800) (11,697) (33,205 |
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| September 8, 2021 |
Affimed Reports Second Quarter 2021 Financial Results and Highlights Operational Progress Exhibit 99.3 ? ? PRESS RELEASE Affimed Reports Second Quarter 2021 Financial Results and Highlights Operational Progress ? AFM13 monotherapy: Enrollment is on track and expected to be completed in the first half of 2022. ? AFM13 combination with NK cells: All three dose escalation cohorts are fully enrolled with no dose limiting toxicities observed; additional patients are being enrolled at the hi |
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| September 8, 2021 |
? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ? FORM 6-K ? Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 ? For the month of September, 2021 ? Commission File Number: 001-36619 ? ? Affimed N.V. ? Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) ? Indicate by check mar |
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| September 8, 2021 |
AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS EX-99.2 3 afmd-20210630xex99d2.htm EXHIBIT-99.2 Exhibit 99.2 AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited interim condensed cons |
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| July 1, 2021 |
EX-99.1 Exhibit 99.1 Affimed N.V. Unaudited consolidated statements of comprehensive income / (loss) (in € thousand) For the three months ended March 31 Note 2021 2020 Revenue 3 11,659 5,135 Other income – net 147 (57 ) Research and development expenses (11,405 ) (11,449 ) General and administrative expenses (4,486 ) (3,525 ) Operating income / (loss) (4,085 ) (9,896 ) Finance income / (costs) – n |
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| July 1, 2021 |
AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Exhibit 99.2 AFFIMED N.V. MANAGEMENT?S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This management?s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited interim condensed consolidated financial statements for the three mont |
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| July 1, 2021 |
Affimed Reports First Quarter 2021 Financial Results and Highlights Operational Progress Exhibit 99.3 PRESS RELEASE Affimed Reports First Quarter 2021 Financial Results and Highlights Operational Progress ? AFM13 monotherapy: Reported positive outcome from the preplanned interim analysis for the registration-directed trial in PTCL; enrollment expected to be completed in the first half of 2022. ? AFM13 combination with NK cells: Announced 100% objective response rate in the first four |
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| July 1, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of July, 2021 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registrant |
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| June 16, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of June, 2021 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registrant |
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| May 20, 2021 |
Newspaper advertisement convocation AGM 2021 Exhibit 99.3 Newspaper advertisement convocation AGM 2021 ?Shareholders of Affimed N.V. are invited to attend the annual general meeting which will be held on June 15, 2021 at 17:30 hrs. CET. In view of the current COVID-19 measures, the meeting will be held entirely virtual. The record date for the meeting is May 18, 2021. The agenda with explanatory notes and the procedure for following the meet |
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| May 20, 2021 |
Affimed Announces Virtual Annual General Meeting of Shareholders Exhibit 99.1 PRESS RELEASE Affimed Announces Virtual Annual General Meeting of Shareholders Heidelberg, Germany, May 20, 2021 ? 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 its 2021 Annual General Meeting of Shareholders (the ?Annual Meeting?) will be held on June 15, 2021 at 17:30 |
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| May 20, 2021 |
Exhibit 99.4 ANNUAL GENERAL MEETING OF SHAREHOLDERS AFFIMED N.V. to be held on Tuesday, 15 June 2021 at 17:30 hrs. (CET) Agenda 1.??Opening Non-Voting 2.??Report by the Management Board for the financial year 2020 Non-Voting 3.??Adoption of the Statutory Annual Accounts for the financial year 2020 Voting item 4.??Discharge of the managing directors for their management during the financial year 20 |
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| May 20, 2021 |
Invitation Annual General Meeting of Shareholders Affimed N.V Exhibit 99.2 Invitation Annual General Meeting of Shareholders Affimed N.V Heidelberg, May 20, 2021 Dear Shareholder, On behalf of Affimed N.V. (the ?Company?), I invite you to attend the Annual General Meeting of Shareholders to be held virtually on Tuesday June 15, 2021 at 17:30 hrs. CET (the ?AGM?). The business to be conducted at this AGM is set out in the AGM agenda (the ?Agenda??), together |
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| May 20, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of May, 2021 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registrant f |
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| May 20, 2021 |
POWER OF ATTORNEY AGM AFFIMED N.V. JUNE 15, 2021 (FOR LEGAL ENTITY) Exhibit 99.5 POWER OF ATTORNEY AGM AFFIMED N.V. JUNE 15, 2021 (FOR LEGAL ENTITY) [insert full name], a legal entity organized and existing under the laws of [insert country], with its seat in [insert name city], having its offices in [insert address] (the ?Grantor?) herewith grants a power of attorney to (please check the box that is applicable): ? (possibility to include name of an authorized per |
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| April 21, 2021 |
Certification of Principal Executive Officer pursuant to 17 CFR 240.13a-14(b) and 18 U.S.C. 1350. EXHIBIT 13.1 CERTIFICATION The certification set forth below is being submitted in connection with Affimed N.V.?s Annual Report on Form 20-F for the fiscal year ended December 31, 2020 (the ?Report?) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the ?Exchange Act?) and Section 1350 of Chapter 63 of Title 18 of the United States Code. Adi |
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| April 21, 2021 |
Certification of Principal Financial and Accounting Officer pursuant to 17 CFR 240.13a-14(a). EXHIBIT 12.2 CERTIFICATION I, Angus W. Smith, certify that: 1. I have reviewed this annual report on Form 20-F of Affimed N.V.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the p |
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| April 21, 2021 |
Schedule 13D UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13D Under the Securities Exchange Act of 1934 (Amendment No. 3)* Affimed N.V. (Name of Issuer) Common Stock, €.01 par value (Title of Class of Securities) N01045108 (CUSIP Number) Louis S. Citron, Esq. New Enterprise Associates 1954 Greenspring Drive, Suite 600, Timonium, MD 21093 (410) 842-4000 (Name, Ad |
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| April 21, 2021 |
Consent of KPMG AG Wirtschaftsprüfungsgesellschaft Exhibit 15.1 Consent of Independent Registered Public Accounting Firm The Supervisory Board of Affimed N.V.: We consent to the incorporation by reference in the registration statements on Form S-8 (No. 333-198812) and Form F-3 (No. 333-251648 and No. 333-227933) of Affimed N.V. of our reports dated April 15, 2021, with respect to the consolidated statements of financial position of Affimed N.V. as |
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| April 21, 2021 |
Certification of Principal Executive Officer pursuant to 17 CFR 240.13a-14 (a). EXHIBIT 12.1 CERTIFICATION I, Adi Hoess, certify that: 1. I have reviewed this annual report on Form 20-F of Affimed N.V.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period |
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| April 21, 2021 |
EXHIBIT 13.2 CERTIFICATION The certification set forth below is being submitted in connection with Affimed N.V.?s Annual Report on Form 20-F for the fiscal year ended December 31, 2020 (the ?Report?) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the ?Exchange Act?) and Section 1350 of Chapter 63 of Title 18 of the United States Code. Ang |
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| April 21, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 20-F/A Amendment No. 1 (Mark One) ? REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020. OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF |
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| April 15, 2021 |
Use these links to rapidly review the document TABLE OF CONTENTS Index to consolidated financial statements Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| April 15, 2021 |
Certification of Principal Executive Officer pursuant to 17 CFR 240.13a-14(b) and 18 U.S.C. 1350. EXHIBIT 13.1 CERTIFICATION The certification set forth below is being submitted in connection with Affimed N.V.?s Annual Report on Form 20-F for the fiscal year ended December 31, 2020 (the ? Report ?) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the ? Exchange Act ?) and Section 1350 of Chapter 63 of Title 18 of the United States Code. |
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| April 15, 2021 |
Certification of Principal Financial and Accounting Officer pursuant to 17 CFR 240.13a-14(a). EXHIBIT 12.2 CERTIFICATION I, Angus W. Smith, certify that: 1. I have reviewed this annual report on Form 20-F of Affimed N.V.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the p |
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| April 15, 2021 |
Affimed Reports 2020 Financial Results and Highlights Recent Operational Progress EX-99.1 Exhibit 99.1 PRESS RELEASE Affimed Reports 2020 Financial Results and Highlights Recent Operational Progress • AFM13 monotherapy: Reported positive data from the preplanned interim analysis for the registration-directed trial in PTCL • AFM13 combination with NK cells: Announced 100% objective response rate in four response evaluable patients, including 2 complete responses • AFM24 monother |
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| April 15, 2021 |
Exhibit 2 Description of rights of each applicable class of securities registered under Section 12 of the Securities Exchange Act of 1934 As of December 31, 2020, Affimed N. |
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| April 15, 2021 |
Current Report of Foreign Issuer - 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of April, 2021 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registrant |
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| April 15, 2021 |
Exhibit 1.1 UNOFFICIAL TRANSLATION ARTICLES OF ASSOCIATION OF AFFIMED N.V. (as per 4 August 2020) ARTICLES OF ASSOCIATION: Chapter 1 Definitions. Article 1. In the articles of association the following terms shall have the meaning as defined below: annual accounts : the annual accounts referred to in section 2:361 CC; annual statement of accounts : the annual accounts and, if applicable, the manag |
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| April 15, 2021 |
Certification of Principal Executive Officer pursuant to 17 CFR 240.13a-14(a). EXHIBIT 12.1 CERTIFICATION I, Adi Hoess, certify that: 1. I have reviewed this annual report on Form 20-F of Affimed N.V.; 2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period |
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| April 15, 2021 |
EXHIBIT 13.2 CERTIFICATION The certification set forth below is being submitted in connection with Affimed N.V.?s Annual Report on Form 20-F for the fiscal year ended December 31, 2020 (the ? Report ?) for the purpose of complying with Rule 13a-14(b) or Rule 15d-14(b) of the Securities Exchange Act of 1934 (the ? Exchange Act ?) and Section 1350 of Chapter 63 of Title 18 of the United States Code. |
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| April 15, 2021 |
Loan Agreement, dated January 8, 2021, between Affimed GmbH, Affimed N.V. and Silicon Valley Bank. Exhibit 4.10 Execution Copy Loan Agreement - Affimed Group (1) Affimed GmbH (as Borrower) (2) Affimed N.V. (as Guarantor) (3) Silicon Valley Bank (as Bank) Dated 8 January 2021 OSBORNE CLARKE RECHTSANW?LTE STEUERBERATER PARTNERSCHAFT MBB osborneclarke.com Table of Content Clause Page 1. Accounting and other Terms 3 2. Loan and Terms of Payment 3 3. Conditions of Loans 7 4. Security Documents 9 5. |
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| April 15, 2021 |
Consent of KPMG AG Wirtschaftsprüfungsgesellschaft Exhibit 15.1 Consent of Independent Registered Public Accounting Firm The Supervisory Board of Affimed N.V.: We consent to the incorporation by reference in the registration statements on Form S-8 (No. 333-198812) and on Form F-3 (No. 333-251648) of Affimed N.V. of our reports dated April 15, 2021, with respect to the consolidated statements of financial position of Affimed N.V. as of December 31, |
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| April 14, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 SCHEDULE 13G (Amendment No. |
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| April 14, 2021 |
Affimed N.V. AACR Review of Interim Data from Phase 1 Study of cbNK Pre-complexed with AFM13 April 14, 2021 Exhibit 99.1 This presentation and the accompanying oral commentary contain ?forward-looking? statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation and the accompanying oral commentary, including s |
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| April 14, 2021 |
Exhibit 99.1 JOINT FILING AGREEMENT The undersigned hereby agree that statements on Schedules 13G and/or 13D and Forms 3, 4 and 5 with respect to the securities of Affimed N.V. and any amendments thereto signed by each of the undersigned shall be filed on behalf of each of the undersigned pursuant to and in accordance with the provisions of Rule 13d-1(k) promulgated under the Securities Exchange A |
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| April 14, 2021 |
Exhibit 10.1 EXECUTION VERSION CONFIDENTIAL CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH ?[*****]?. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT (I) IS NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. Patent and Technology License Agreement This Patent and Technology License Agreement (?Agree |
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| April 14, 2021 |
Current Report of Foreign Issuer - 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of April, 2021 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registrant |
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| April 9, 2021 |
Current Report of Foreign Issuer - 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of April, 2021 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registrant |
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| April 9, 2021 |
Exhibit 99.1 PRESS RELEASE Affimed Announces Presentation at AACR Highlighting Initial Data from Phase 1 Study of Cord Blood-derived Natural Killer Cells Pre-complexed with Innate Cell Engager AFM13 ? All four patients experienced significant disease reduction, with two complete responses and two partial responses as assessed by the investigator, with an objective response rate of 100% ? There wer |
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| March 10, 2021 |
EX-99.1 2 d149931dex991.htm EX-99.1 Exhibit 99.1 PRESS RELEASE Affimed Announces Continuation of REDIRECT, a Registration-directed Study of AFM13 in PTCL, after Positive Preplanned Interim Futility Analysis • Study will continue and combine cohorts of CD30 high and CD30 low expressing PTCL based on assessment from Independent Review Committee • Objective responses observed in heavily pretreated pa |
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| March 10, 2021 |
Current Report of Foreign Issuer - 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of March, 2021 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registrant |
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| February 12, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 2)* Affimed N.V. (Name of Issuer) Common Shares (Title of Class of Securities) N01045108 (CUSIP Number) December 31, 2020 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to which this Schedule |
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| February 8, 2021 |
240.13d-102 Schedule 13G - Information to be included in statements filed pursuant to 240.13d-1(b), (c), and (d) and amendments thereto filed pursuant to 240.13d-2. Securities and Exchange Commission, Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No.)* (Name of Issuer) Affimed N.V. (Title of Class of Securities) Common Shares, nominal value €0.01 per shar |
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| February 8, 2021 |
Exhibit 99.1 JOINT FILING AGREEMENT The undersigned hereby agree that the foregoing statement on Schedule 13G is filed on behalf of each of the undersigned in accordance with the provisions of Rule 13d-1(k) under the Securities Exchange Act of 1934, as amended, and that all subsequent amendments to this statement on Schedule 13G may be filed on behalf of each of the undersigned without the necessi |
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| January 19, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (AMENDMENT NO. 1) AFFIMED N.V. (Name of Issuer) COMMON SHARES, NOMINAL VALUE €0.01 PER SHARE (Title of Class of Securities) N01045108 (CUSIP Number) DECEMBER 31, 2020 (Date of event which requires filing of this statement) Check the appropriate box to designate the rule pu |
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| January 15, 2021 |
EX-1.1 Exhibit 1.1 Affimed N.V. 16,666,667 Common Shares (Par Value €0.01 Per Share) UNDERWRITING AGREEMENT January 12, 2021 Jefferies LLC SVB Leerink LLC Credit Suisse Securities (USA) LLC As Representatives of the several Underwriters c/o Jefferies LLC 520 Madison Avenue New York, New York 10022 c/o SVB Leerink LLC 1301 Avenue of the Americas, 12th Floor New York, New York 10019 c/o Credit Suiss |
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| January 15, 2021 |
Current Report of Foreign Issuer - 6-K 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of January, 2021 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the regi |
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| January 14, 2021 |
16,666,667 Shares Common Shares 424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-251648 PROSPECTUS SUPPLEMENT (To Prospectus dated December 30, 2020) 16,666,667 Shares Common Shares We are offering 16,666,667 common shares. Our common shares trade on The Nasdaq Global Market, or Nasdaq, under the trading symbol “AFMD.” On January 11, 2021, the last sale price of our common shares as reported on Nasda |
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| January 13, 2021 |
SUBJECT TO COMPLETION, DATED JANUARY 12, 2021 424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-251648 The information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed with the Securities and Exchange Commission is effective. SUBJECT TO COMPLETION, DATED JANUARY 12, 2021 PRELIMINARY PROSPECTUS SUPPLEMENT (To Prospectus dated December 30, |
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| December 30, 2020 |
Affimed N.V. Technologiepark, Im Neuenheimer Feld 582 69120 Heidelberg, Germany December 30, 2020 Affimed N.V. Technologiepark, Im Neuenheimer Feld 582 69120 Heidelberg, Germany December 30, 2020 Via EDGAR Submission Securities and Exchange Commission 100 F Street, N.E. Washington, D.C. 20549 Re: Affimed N.V. Registration Statement on Form F-3 Filed December 23, 2020 CIK No. 0001608390 Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended (the ?Sec |
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| December 23, 2020 |
Form F-3 Table of Contents As filed with the Securities and Exchange Commission on December 23, 2020 Registration No. |
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| December 23, 2020 |
Articles of Association of Affimed N.V. EX-4.1 Exhibit 4.1 DE BRAUW BLACKSTONE WESTBROEK UNOFFICIAL TRANSLATION DEED OF AMENDMENT OF THE ARTICLES OF ASSOCIATION AFFIMED N.V. On the fourth day of August two thousand and twenty appears before me, Reinier Hans Kleipool, civil law notary in Amsterdam: Gerrit Aaltinus Slatman, candidate civil law notary, working at the offices of De Brauw Blackstone Westbroek N.V., with seat in Amsterdam, at |
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| November 10, 2020 |
Current Report of Foreign Issuer - 6-K 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of November, 2020 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the reg |
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| November 10, 2020 |
EX-99.1 Exhibit 99.1 Execution Version OPEN MARKET SALE AGREEMENTSM November 10, 2020 JEFFERIES LLC 520 Madison Avenue New York, New York 10022 Ladies and Gentlemen: Affimed N.V., a company incorporated under the laws of the Netherlands (the “Company”), proposes, subject to the terms and conditions stated herein, to issue and sell from time to time through Jefferies LLC, as sales agent and/or prin |
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| November 10, 2020 |
424B5 1 d687326d424b5.htm 424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-227933 PROSPECTUS SUPPLEMENT (To Prospectus dated November 7, 2018) $75,000,000 Common Shares We have entered into a Sales Agreement, or sales agreement, with Jefferies LLC or Jefferies, dated November 10, 2020, relating to the sale of our common shares offered by this prospectus supplement. In |
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| November 10, 2020 |
6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of November, 2020 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the reg |
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| November 10, 2020 |
Affimed Reports Third Quarter 2020 Financial Results and Highlights Recent Operational Progress EX-99.3 Exhibit 99.3 PRESS RELEASE Affimed Reports Third Quarter 2020 Financial Results and Highlights Recent Operational Progress • Established license and strategic collaboration with Roivant Sciences - $60 million in upfront consideration and up to $2 billion in future milestones • Recognized milestone payment from Genentech for initiation of Phase 1 of RO7297089 • Ended quarter with €97.3 mill |
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| November 10, 2020 |
EX-99.1 Exhibit 99.1 Affimed N.V. Unaudited consolidated statements of comprehensive income/(loss) (in € thousands) For the three months ended September 30 For the nine months ended September 30 Note 2020 2019 2020 2019 Revenue 3 10,545 2,103 18,614 17,464 Other income – net 102 49 130 332 Research and development expenses (10,101 ) (11,721 ) (33,247 ) (31,253 ) General and administrative expenses |
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| November 10, 2020 |
AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS EX-99.2 Exhibit 99.2 AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited interim condensed consolidated financial statements for the th |
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| November 9, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of November, 2020 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registr |
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| November 9, 2020 |
Exhibit 99.1 PRESS RELEASE Affimed and Roivant Sciences Announce Licensing and Strategic Collaboration Agreement to Develop and Commercialize Novel Innate Cell Engagers (ICE?) for Multiple Cancer Targets ? Affimed to grant license to AFM32 with options for additional ICE? molecules directed against targets not included in Affimed?s current pipeline ? Affimed to receive $60 million in upfront consi |
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| November 9, 2020 |
Exhibit 10.1 CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT HAVE BEEN OMITTED AND REPLACED WITH ?[*****]?. SUCH IDENTIFIED INFORMATION HAS BEEN EXCLUDED FROM THIS EXHIBIT BECAUSE IT IS (I) NOT MATERIAL AND (II) WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF DISCLOSED. EXECUTION VERSION CONFIDENTIAL RESEARCH COLLABORATION AND LICENSE AGREEMENT BETWEEN AFFIMED GMBH AND PHARMAVANT 6 GMBH AS OF |
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| August 11, 2020 |
AFFIMED N.V. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS Exhibit 99.1 AFFIMED N.V. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS Affimed N.V. Unaudited consolidated statements of comprehensive income / (loss) (in € thousand) For the three months ended June 30 For the six months ended June 30 Note 2020 2019 2020 2019 Revenue 3 2,934 4,008 8,069 15,361 Other income - net 85 197 28 283 Research and development expenses (11,697) (11,545) (23,146) (19,532) Gen |
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| August 11, 2020 |
AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Exhibit 99.2 AFFIMED N.V. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited interim condensed consolidated financial statements for the three and |
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| August 11, 2020 |
Affimed Reports Second Quarter 2020 Financial Results and Operational Progress Exhibit 99.3 PRESS RELEASE 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 |
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| August 11, 2020 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of August, 2020 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the registran |
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| August 5, 2020 |
Current Report of Foreign Issuer - 6-K 6-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of August, 2020 Commission File Number: 001-36619 Affimed N.V. Im Neuenheimer Feld 582, 69120 Heidelberg, Germany (Address of principal executive offices) Indicate by check mark whether the regis |
