AFMD Affimed NV

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 registrant files or will file annual reports under cover of Form 20-F or Form 40-F

☒  Form 20-F            ☐  Form 40-F

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐

Affimed N.V.

On January 3, 2024, Affimed N.V. (the “Company” or “Affimed”) issued a press release titled “Affimed Announces Sale of Wholly-Owned Subsidiary AbCheck” announcing that the Company has reached a definitive agreement to sell its wholly-owned subsidiary, AbCheck s.r.o., to Ampersand Biomedicines (“Ampersand”).

Under the terms of the agreement, Ampersand will acquire AbCheck for a purchase price of $6 million, consisting of $5 million in cash to be paid in two tranches, and $1 million in Ampersand common stock, subject to certain adjustments and a holdback. Affimed is also entitled to receive milestone payments from a pre-existing AbCheck partnership.

On January 8, 2024, Affimed N.V. (the “Company” or “Affimed”) issued a press release titled “Affimed Announces Leadership Change and Organizational Restructuring” announcing that Dr. Adi Hoess, Chief Executive Officer (“CEO”) and member of the Management Board, will step down effective January 15, 2024.

The Company has initiated a comprehensive search process to identify a successor CEO. In the interim, Dr. Andreas Harstrick, Chief Medical Officer (“CMO”) of the Company, will assume the role of interim CEO until a new CEO is appointed. Andreas has nearly 25 years of extensive experience in cancer drug development, including strategic leadership of three global phase 3 programs of new biological entities that culminated in global regulatory approvals, and multiple pivotal phase 3 studies. Given the clinical focus of the company, Andreas is well positioned to lead the company through the transition to a new CEO while continuing as CMO.

Andreas and the management team will be supported by Dr. Annalisa Jenkins, who will ensure close coordination between the Management and Supervisory Boards until a new CEO is appointed. Dr. Jenkins has significant industry experience and has held key leadership positions including the CEO of a NASDAQ publicly traded company, Dimension Therapeutics, and head of global research and development at Merck Serono, which make her well-suited for this role.

In addition, the Company also announced a restructuring initiative aimed at transforming the Company into a focused clinical organization, positioned to successfully advance its programs to key value inflection points.

As part of the restructuring, Affimed will direct all resources towards advancing the development of its clinical programs, resulting in a reduction of up to 50% of its workforce by dissolving its research and preclinical development departments, aligned with the Company’s narrowed strategic priorities. The restructuring plan will extend Affimed’s cash runway into the second half of 2025.

Copies of the press releases are attached hereto as Exhibits 99.1 and 99.2 and are being furnished and shall not be deemed filed or incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, except as expressly set forth by specific reference in such a filing.

FORWARD-LOOKING STATEMENTS

This report contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of acimtamig (AFM13), AFM24, AFM28 and the Company’s other product candidates, the value of its ROCK^® platform, its ongoing and planned preclinical development and clinical trials, the restructuring plan, including the workforce reduction, dissolution of the research department and divestiture of AbCheck, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which it operates, the macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict, the fact that the current clinical data of acimtamig (AFM13) in combination with NK cell therapy is based on acimtamig (AFM13) precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AlloNK^® and other uncertainties and factors described under the heading “Risk Factors” in Affimed’s filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

EXHIBIT INDEX

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.o., to Ampersand Biomedicines.

Under the terms of the agreement, Ampersand Biomedicines will acquire AbCheck for a purchase price of $6 million, consisting of $5 million in cash to be paid in two tranches, and $1 million in Ampersand common stock, subject to certain adjustments and a holdback. Affimed is also entitled to receive milestone payments from a pre-existing AbCheck partnership.

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s proprietary ROCK^® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK^® platform predictably generates customized innate cell engager (ICE^®) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE^®. Headquartered in Mannheim, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: www.affimed.com.

About Abcheck

AbCheck discovers and optimizes human therapeutic antibodies with one of the industry’s most versatile technology platforms. Tailored to specific needs and desired Target Product Profiles, AbCheck leverages both cutting edge (e.g., microfluidics, rabbit mass humanization) and classical (e.g., phage/yeast display libraries) technologies to provide high quality leads. The company has proven its capabilities in multiple partnerships throughout the US and Europe. Following the completion of the transaction, AbCheck will become a wholly-owned subsidiary of Ampersand Biomedicines, a Flagship Pioneering Company. For more information, please visit https://www.abcheckantibodies.com/.

Forward-Looking Statement

This report contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Actual results may differ materially from the results anticipated by the Company’s forward-looking statements due to certain risks, uncertainties and other factors described under the heading “Risk Factors” in Affimed’s filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

Investor Relations Contact

Alexander Fudukidis

Director, Investor Relations

E-Mail: a.fudukidis@affimed.com

Tel.: +1 (917) 436-8102

Media Contact

Mary Beth Sandin

Vice President, Marketing and Communications

E-Mail: m.sandin@affimed.com

Exhibit 99.2

PRESS RELEASE    

Affimed Announces Leadership Change and

Organizational Restructuring

Mannheim, Germany, January 8, 2024 – Affimed N.V. (Nasdaq: AFMD) (the “Company” or “Affimed”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced that Dr. Adi Hoess, Chief Executive Officer and member of the Management Board, will step down effective January 15, 2024. Dr. Hoess joined Affimed in October 2010 and has served as its Chief Executive Officer since September 2011.

“On behalf of Affimed, I would like to thank Adi for his dedication to the Company. Over the past 13 years, he contributed significantly to the Company’s success and guided Affimed’s evolution from an antibody engineering company to an innovative late-stage clinical biotech,” said Dr. Thomas Hecht, Chairman of the Supervisory Board. “On behalf of Affimed, I wish Adi all the best in his future endeavors.”

“Leading Affimed has been an exciting and rewarding journey for me and I am proud of the results achieved—an innovative pipeline of assets for the company and its partners,” said Dr. Adi Hoess, Chief Executive Officer. “It has been a privilege to work with the talented and dedicated Affimed team, which shares a strong commitment to deliver meaningful new therapies to patients who need them, and I am confident the Company is well positioned to fulfill its mission.”

The Company has initiated a comprehensive search process to identify a successor CEO. In the interim, Dr. Andreas Harstrick, Chief Medical Officer of the Company, will assume the role of interim CEO until a new CEO is appointed. Andreas has nearly 25 years of extensive experience in cancer drug development, including strategic leadership of three global phase 3 programs of new biological entities that culminated in global regulatory approvals, and multiple pivotal phase 3 studies. Given the clinical focus of the company, Andreas is well positioned to lead the company through the transition to a new CEO while continuing as CMO.

Andreas and the management team will be supported by Dr. Annalisa Jenkins, who will ensure close coordination between the Management and Supervisory Boards until a new CEO is appointed. Dr. Jenkins has significant industry experience and has held key leadership positions including CEO of NASDAQ publicly traded company Dimension Therapeutics and head of global research and development at Merck Serono, which make her well-suited for this role.

Strategic Restructuring

Affimed also announced today a restructuring initiative aimed at transforming the Company into a focused clinical organization, positioned to successfully advance its clinical programs to key value inflection points.

Key highlights of the restructuring plan include:

The company announced earlier this month the divestiture of AbCheck, the proceeds of which will support ongoing clinical development activities.

The Company confirms guidance related to data readouts in the first half of 2024:

The Management Board and Supervisory Board of Affimed are confident that these changes are in the best interest of our patients and shareholders and will enable on-going execution of clinical priorities.

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s proprietary ROCK^® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK^® platform predictably generates customized innate cell engager (ICE^®) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE^®. Headquartered in Mannheim, Germany, with offices in Philadelphia, PA. Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: www.affimed.com.

Forward-Looking Statement

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of acimtamig (AFM13), AFM24, AFM28 and the Company’s other product candidates, the value

of its ROCK^® platform, its ongoing and planned preclinical development and clinical trials, the restructuring plan, including the workforce reduction, dissolution of the research department and divestiture of AbCheck, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which it operates, the macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict, the fact that the current clinical data of acimtamig (AFM13) in combination with NK cell therapy is based on acimtamig (AFM13) precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AlloNK^® and other uncertainties and factors described under the heading “Risk Factors” in Affimed’s filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

Investor Relations Contact

Alexander Fudukidis

Director, Investor Relations

E-Mail: a.fudukidis@affimed.com

Tel.: +1 (917) 436-8102

Media Contact

Mary Beth Sandin

Vice President, Marketing and Communications

E-Mail: m.sandin@affimed.com