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 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 April 15, 2021, Affimed N.V. issued a press release, a copy of which is attached hereto as Exhibit 99.1.

 

1


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 15, 2021.

 

AFFIMED N.V.
By:  

/s/ Adi Hoess

Name: Adi Hoess
Title: Chief Executive Officer
By:  

/s/ Angus Smith

Name: Angus Smith
Title: Chief Financial Officer

 

2


EXHIBIT INDEX

 

Exhibit

  

Description of Exhibit

99.1*    Affimed N.V. Press Release dated April 15, 2021.

 

*

Exhibit 99.1 to this Report on Form 6-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.

 

3

EX-99.1

Exhibit 99.1

 

LOGO

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 monotherapy: AFM24 (phase 1/2a study) completed cohort 4 and is enrolling and treating patients in cohort 5; expansion cohorts expected to start in the second half of 2021

 

   

AFM24 combination with NK cells: IND application cleared by the FDA for the combination of AFM24 with NKGen Biotech’s SNK-01 NK autologous cell therapy

 

   

AFM24 combination with anti PD-L1 antibody: Established a collaboration with Roche to clinically explore the combination of AFM24 with atezolizumab (Tecentriq®)

 

   

Made continued progress in advancing and forming partnerships with Genentech and Roivant, which triggered payments to Affimed

 

   

Pro forma cash and cash equivalents as of December 31, 2020 were approximately €244.5 million (inclusive of Q1 equity offering and loan proceeds) with anticipated cash runway into the second half of 2023

 

   

Conference call and webcast scheduled for April 15, 2021 at 8:30 a.m. EDT

Heidelberg, Germany, April 15, 2021 – Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results for the year ended December 31, 2020 and provided an update on clinical and corporate progress.

“2020 was an important year for Affimed. We continued to build on the strong foundation of our scientific discoveries and made significant progress across all our programs. We broadened our clinical pipeline, added new collaborations, built a strong balance sheet, appointed key senior management executives and ensured that our programs stayed on track through the global pandemic,” said Dr. Adi Hoess, CEO of Affimed. “We entered 2021 with strong momentum, and the recently announced positive outcome of our interim futility analysis for our registration directed study of AFM13 as monotherapy in PTCL patients, and initial data from the trial investigating AFM13 pre-complexed natural killer cells in Hodgkin lymphoma patients provide further validation for our three-pronged development strategy. As we look ahead into 2021, we anticipate numerous additional updates as we advance our programs.”

 

1


Clinical Stage Program Updates

Three-pronged Development Strategy

Based on preclinical and clinical data, Affimed is pursuing development of its innate cell engagers (ICE®) as monotherapy, and in combination with adoptive NK cell transfer and PD-1/PD-L1 checkpoint inhibitors.

AFM13 (CD30/CD16A)

 

   

In March 2021, Affimed reported positive results from the preplanned interim futility analysis for AFM13-202, its phase 2 registration-directed study of AFM13 (CD16A/CD30) as monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL). The futility analysis demonstrated that the response rate in Cohort A achieved the predefined threshold for continuation of the study. The response rate in Cohort B was sufficiently comparable to allow merging of both cohorts into a single cohort for all patients with CD30 >1%, per the study protocol. Evidence of anti-tumor response was observed in both cohorts with complete and partial responses. The trial will continue by combining the high- and low-CD30 expressing cohorts into one.

 

   

In April 2021, Affimed reported positive initial clinical data from the investigator sponsored trial (IST) at The University of Texas MD Anderson Cancer Center evaluating increasing doses of cord-blood derived NK cells pre-complexed with AFM13 (CD16A/CD30) followed by three weekly infusions of AFM13 monotherapy in patients with recurrent or refractory CD30 positive lymphomas. As of March 31, 2021, all four response evaluable patients, including three patients in cohort 1 (1x106 AFM13-cbNK/kg) and one patient in cohort 2 (1x107 AFM13-cbNK/kg), have achieved an objective response, including two complete responses, according to investigator assessments by Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC). All four patients had relapsed / refractory Hodgkin lymphoma and were heavily pretreated, with between four and 14 previous lines of therapy which in all cases included brentuximab vedotin (Adcetris®) and anti-PD1 antibodies.

AFM24 (EGFR/CD16A)

 

   

AFM24-101, the phase 1/2a clinical trial of AFM24, the EGFR/CD16A targeted ICE® for patients with EGFR-expressing solid tumors, completed dose cohort 4 (160 mg) and patients are currently being enrolled and treated in dose cohort 5 (320 mg). Affimed expects to provide an update on the dose escalation and initiate the dose expansion cohorts during 2021.

 

2


   

An investigational new drug (IND) application was cleared by the U.S. Food and Drug Administration to investigate the combination of AFM24 with NKGen Biotech’s (formerly known as NKMax America) autologous NK cell therapy, SNK01, in a first-in-human proof of concept (POC) trial in patients with EGFR-expressing tumors. Affimed expects to initiate the study in the second half of 2021.

 

   

Affimed entered into a clinical collaboration with Roche for a phase 1/2a study evaluating AFM24 in combination with the PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®) in EGFR-expressing solid tumors. The phase 1 portion of the study will establish a dosing regimen and assess safety for the combination; in the subsequent phase 2a portion of the study, the clinical activity of the combination will be evaluated in specific tumor types. Affimed expects to initiate the study in the second half of 2021.

 

   

Preclinical data was presented at AACR 2021 showing the potential of AFM24 as monotherapy and in combination with NK cells. As monotherapy, AFM24 induces tumor cell killing independent of KRAS mutations; and, in combination with adoptive NK cells, it leads to AFM24 dose-dependent tumor regression.

Preclinical and Partnered Programs

 

   

AFM28 progressed further in IND-enabling studies and Affimed expects an IND application will be filed in the first half of 2022.

 

   

In November 2020, Affimed entered into a licensing and strategic collaboration agreement with Roivant Sciences and granted Roivant a license to AFM32 with options for additional ICE® molecules against targets not included in Affimed’s current pipeline. AFM32 will be investigated in solid tumors.

 

   

In August 2020, Affimed announced that Genentech’s RO7297089, a CD16A/BCMA targeting ICE®, is actively recruiting patients into a first-in-human phase 1 trial resulting in the achievement of a milestone payment under the terms of the collaboration.

 

   

Affimed entered a collaboration with Artiva Biotherapeutics to assess feasibility and activity of pre-manufactured, co-vialed, cryopreserved, off-the-shelf NK cell combination therapeutics. The R&D collaboration is assessing the feasibility and preclinical activity of combinations of Artiva’s allogeneic NK cell product AB-101 and Affimed’s ICE® molecules, building on earlier preclinical studies demonstrating synergistic cytotoxic activity.

Other Corporate Updates

 

   

In January 2021, Affimed completed a $115 million underwritten public offering to accelerate and expand the development and manufacturing of its clinical and preclinical ICE® molecules.

 

   

In January 2021, Affimed entered into a financing agreement with Silicon Valley Bank for up to €25 million in term loans, with €10 million available at closing.

Full Year 2020 Financial Highlights

As of December 31, 2020, cash, cash equivalents and current financial assets totaled €146.9 million compared to €104.1 million on December 31, 2019. The pro forma cash position as of December 31, 2020, including net proceeds from the January 2021 underwritten public offering and the first tranche of the Silicon Valley Bank loan, would be approximately €244.5 million.

 

3


Based on its current operating plan and assumptions, Affimed anticipates that its cash and cash equivalents will support operations into the second half of 2023.

Net cash used in operating activities for the year ended December 31, 2020 amounted to €19.4 million compared to €29.1 million for the year ended December 31, 2019. The amount received in 2020 includes an initial upfront payment and committed funding of €33.3 million (US$ 40 million) from the Roivant collaboration.

Total revenue for the year ended December 31, 2020 was €28.4 million compared with €21.4 million for the year ended December 31, 2019. Revenue for 2020 and 2019 predominantly relate to the Genentech collaboration. Collaboration revenue for the year ended December 31, 2020 amounted to €27.8 million, with €26.2 million from the Genentech collaboration and €1.4 million from the Roivant collaboration. Collaboration revenue of €19.7 million for the year ended December 31, 2019 was from the Genentech collaboration.

Research and development expenses for 2020 increased 14.2% from €43.8 million in the year ended December 31, 2019 to €50.0 million in the year ended December 31, 2020, due to higher expenses for AFM24 and our other projects and infrastructure investments.

General and administrative expenses increased 33.6% from €10.3 million in the year ended December 31, 2019 to €13.7 million in the year ended December 31, 2020. In 2020, general and administrative expenses were largely comprised of personnel expenses of €6.3 million and legal, consulting and audit costs of €5.6 million.

Finance costs for the year ended December 31, 2020 were €6.6 million, compared to finance income of €15 thousand for the year ended December 31, 2019. Finance costs for the year ended December 31, 2020 were largely comprised of foreign exchange losses related to assets denominated in U.S. dollars as a result of the weakening of the U.S. dollar compared to the Euro during the year.

Net loss for the year ended December 31, 2020 was €41.4 million, or €0.50 per common share compared with a net loss of €32.4 million, or €0.50 per common share, for the year ended December 31, 2019.

The weighted number of common shares outstanding for the year ended December 31, 2020 was 83.5 million.

Additional information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2020 and “Item 5. Operating and Financial Review and Prospects,” which will be included in Affimed’s Annual Report on Form 20-F as filed with the U.S. Securities and Exchange Commission (SEC).

Note on International Financial Reporting Standards (IFRS)

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

 

4


Conference Call and Webcast Information

Affimed will host a conference call and webcast today, April 15, 2021 at 8:30 a.m. EDT to discuss fourth quarter 2020 financial results and recent corporate developments. The conference call will be available via phone and webcast.

To access the call, please dial +1 (646) 741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference passcode 4271307 approximately 15 minutes prior to the call.

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

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer 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 Heidelberg, 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.

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 potential of AFM13, AFM24, and our other product candidates, 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

 

5


regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, 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, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation and the 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 we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.

Investor Relations Contact

Alexander Fudukidis

Director, Head of Investor Relations

E-Mail: a.fudukidis@affimed.com

Tel.: +1 (917) 436-8102

 

6


Affimed N.V.

Consolidated statements of comprehensive income / (loss) (in € thousand)

 

     2020     2019     2018  

Revenue

     28,360       21,391       23,735  

Other income - net

     626       290       1,515  

Research and development expenses

     (49,989     (43,791     (35,148

General and administrative expenses

     (13,715     (10,266     (9,638
  

 

 

   

 

 

   

 

 

 

Operating loss

     (34,718     (32,376     (19,536

Finance income / (costs) - net

     (6,647     15       60  
  

 

 

   

 

 

   

 

 

 

Loss before tax

     (41,365     (32,361     (19,476

Income taxes

     (1     (4     (1
  

 

 

   

 

 

   

 

 

 

Loss for the period

     (41,366     (32,365     (19,477
  

 

 

   

 

 

   

 

 

 

Other comprehensive income / (loss)

      

Items that will not be reclassified to profit or loss

Equity investments at fair value OCI - net change in

      

fair value

     (242     (632     (4,731
  

 

 

   

 

 

   

 

 

 

Other comprehensive income / (loss)

     (242     (632     (4,731
  

 

 

   

 

 

   

 

 

 

Total comprehensive Loss

     (41,608     (32,997     (24,208
  

 

 

   

 

 

   

 

 

 

Earnings / (loss) per share in € per share (undiluted = diluted)

     (0.50     (0.50     (0.32

Weighted number of common shares outstanding

     83,471,559       64,242,396       60,514,407  

 

7


Affimed N.V.

Consolidated statements of financial position (in € thousand)

 

     December
31, 2020
    December
31, 2019
 

ASSETS

    

Non-current assets

    

Intangible assets

     1,718       137  

Leasehold improvements and equipment

     2,226       2,291  

Long term financial assets

     20,042       3,193  

Right-of-use assets

     940       824  
  

 

 

   

 

 

 
     24,926       6,445  

Current assets

    

Cash and cash equivalents

     146,854       95,234  

Financial assets

     0       8,902  

Trade and other receivables

     2,439       1,482  

Inventories

     246       296  

Other assets

     1,260       0  
  

 

 

   

 

 

 
     150,799     105,914  

TOTAL ASSETS

     175,725       112,359  

EQUITY AND LIABILITIES

    

Equity

    

Issued capital

     983       762  

Capital reserves

     345,164       270,451  

Fair value reserves

     1,720       1,962  

Accumulated deficit

     (275,874     (234,508
  

 

 

   

 

 

 

Total equity

     71,993       38,667  

Non-current liabilities

    

Borrowings

     231       278  

Contract liabilities

     35,992       37,961  

Lease liabilities

     482       272  
  

 

 

   

 

 

 

Total non-current liabilities

     36,705       38,511  

Current liabilities

    

Trade and other payables

     11,394       10,674  

Provisions

     0       517  

Borrowings

     92       2,105  

Lease liabilities

     492       532  

Contract liabilities

     55,049       21,353  
  

 

 

   

 

 

 

Total current liabilities

     67,027       35,181  

TOTAL EQUITY AND LIABILITIES

     175,725       112,359  

 

8


Affimed N.V.

Consolidated statements of cash flows (in € thousand)

 

     2020     2019     2018  

Cash flow from operating activities

      

Income / (loss) for the period

     (41,366     (32,365     (19,477

Adjustments for the period:

      

- Income taxes

     1       4       1  

- Depreciation and amortisation

     1,115       906       403  

- Net gain / loss from disposal of leasehold improvements and equipment

     34       (5     25  

- Share based payments

     3,381       2,469       2,035  

- Finance income / costs—net

     6,647       (15     (60
  

 

 

   

 

 

   

 

 

 
     (30,188)     (29,006)     (17,073)  

Change in trade and other receivables

     (1,065     33       (322

Change in inventories

     50       (36     (19

Change in other assets

     (1,260     340       121  

Change in trade, other payables, provisions and contract liabilities

     12,848       (791     66,856  
  

 

 

   

 

 

   

 

 

 

Cash used in operating activities

     (19,615     (29,460     49,563  

Interest received

     294       628       218  

Paid interest

     (78     (224     (342

Paid income tax

     (1     0       (1
  

 

 

   

 

 

   

 

 

 

Net cash used in operating activities

     (19,400     (29,056     49,438  

Cash flow from investing activities

      

Purchase of intangible assets

     (9     (150     (30

Purchase of leasehold improvements and equipment

     (431     (1,324     (691

Cash received from the sale of leasehold improvements and equipment

     0       0       1  

Cash paid for investments in financial assets

     (8,101     (45,131     (14,029

Cash received from maturity of financial assets

     16,547       50,945       0  

Cash paid for investments in long term financial assets

     0       0       (861
  

 

 

   

 

 

   

 

 

 

Net cash used for investing activities

     8,006       4,340       (15,610

Cash flow from financing activities

      

Proceeds from issue of common shares

     74,195       31,373       25,113  

Transaction costs related to issue of common shares

     (2,294     (2,215     (1,701

Proceeds from borrowings

     0       562       0  

Repayment of lease liabilities

     (521     (405     0  

Repayment of borrowings

     (2,128     (3,277     (2,917
  

 

 

   

 

 

   

 

 

 

Cash flow from financing activities

     69,252       26,038       20,495  
  

 

 

   

 

 

   

 

 

 

Exchange-rate related changes of cash and cash equivalents

     (6,238     (917     669  

Net changes to cash and cash equivalents

     57,858       1,322       54,323  

Cash and cash equivalents at the beginning of the period

     95,234       94,829       39,837  
  

 

 

   

 

 

   

 

 

 

Cash and cash equivalents at the end of the period

     146,854       95,234       94,829  
  

 

 

   

 

 

   

 

 

 

 

9


Affimed N.V.

Consolidated statements of changes in equity (in € thousand)

 

     Issued
capital
     Capital
reserves
     Fair value
reserves
   

Accumulated

deficit

    Total equity  

Balance as of January 1, 2018

     468        213,778        7,325       (182,667     38,904  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Issue of common shares

     156        23,171            23,327  

Exercise of share based payment awards

        71            71  

Equity-settled share based payment awards

        2,035            2,035  

Loss for the period

             (19,477     (19,477

Other comprehensive income

           (4,731       (4,731
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance as of December 31, 2018

     624        239,055        2,594       (202,144     40,129  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance as of January 1, 2019

     624        239,055        2,594       (202,144     40,129  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Issue of common shares

     138        28,901            29,039  

Exercise of share based payment awards

        26            26  

Equity-settled share based payment awards

        2,469            2,469  

Loss for the period

             (32,365     (32,365

Other comprehensive income

           (632       (632
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance as of December 31, 2019

     762        270,451        1,962       (234,508     38,667  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance as of January 1, 2020

     762        270,451        1,962       (234,508     38,667  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Issue of common shares

     205        68,341            68,546  

Exercise of share based payment awards

     16        2,991            3,007  

Equity-settled share based payment awards

        3,381            3,381  

Loss for the period

             (41,366     (41,366

Other comprehensive income

           (242       (242
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance as of December 31, 2020

     983        345,164        1,720       (275,874     71,993  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

 

10