UNITED STATES 

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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FORM 6-K

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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, 2019

 

Commission File Number: 001-36619

 

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Affimed N.V.

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Im Neuenheimer Feld 582,

69120 Heidelberg,

Germany

(Address of principal executive offices)

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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 x       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): ☐

 

INCORPORATION BY REFERENCE

 

Exhibit 99 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration Number 333-227933) and Form S-8 (Registration Numbers 333-198812) of Affimed N.V. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

 

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, in Heidelberg, Germany, April 17, 2019.

 

	AFFIMED N.V.
	By:	/s/ Adi Hoess
		Name:	Adi Hoess
		Title:	Chief Executive Officer
	By:	/s/ Florian Fischer
		Name:	Florian Fischer
		Title:	Chief Financial Officer

EXHIBIT INDEX

 

Exhibit	Description of Exhibit
99	Press Release dated April 17, 2019

 

 

Exhibit 99

 

 

 

 

FOR IMMEDIATE RELEASE

 

Affimed Provides Regulatory Update on AFM11 Clinical Program

 

Heidelberg, Germany, April 17, 2019 - Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, today announced that it has submitted to the U.S. Food and Drug Administration (FDA) additional information to Affimed’s initial response document submitted in early March relating to the previously-announced clinical hold on AFM11. The additional information addresses the request from the FDA for the clinical trial protocol for the study of AFM11 for treatment of acute lymphocytic leukemia (ALL). Affimed anticipates receiving a response from the FDA regarding the status of the AFM11 clinical program in the second quarter of 2019.

 

About Affimed N.V.

 

Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer. Affimed’s fit-for-purpose ROCK® platform allows innate immune engagers to be designed for specific patient populations. The Company is developing single and combination therapies to treat cancers. For more information, please visit www.affimed.com.

 

FORWARD-LOOKING STATEMENTS

 

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 our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the value of our ROCK® platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates our intellectual property position, our collaboration activities, our ability to develop commercial functions, expectations regarding clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us and the risks uncertainties and other factors described under the heading “Risk Factors” in Affimed’s filings with the Securities and Exchange Commission. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.

 

Affimed Investor Contact:

 

Gregory Gin, Head of Investor Relations

 

E-Mail: IR@affimed.com

 

Affimed Media Contact:

 

Anca Alexandru, Head of Communications, EU IR

 

E-Mail: media@affimed.com