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, 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 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 March 31, 2022, Affimed N.V. issued a press release, a copy of which is attached hereto as Exhibit 99.1.

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.


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, March 31, 2022.

 

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


EXHIBIT INDEX

 

Exhibit   

Description of Exhibit

99.1    Affimed N.V. Press Release dated March 31, 2022.
EX-99.1

Exhibit 99.1

 

LOGO

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 NK cell dose. Data after two treatment cycles will be presented orally at the AACR Clinical Trials Plenary session on April 10, 2022

 

   

Initiated enrollment in the expansion phase of the AFM24-101 monotherapy trial at the recommended phase 2 dose (RP2D); a poster from the dose escalation will be presented at AACR on April 11, 2022

 

   

Enrollment is underway in two separate phase 1/2a studies investigating AFM24 in combination with atezolizumab (AFM24-102) and SNK01 NK cells (AFM24-103)

 

   

IND filing for AFM28, a CD123/CD16A innate cell engager (ICE®) for AML, is expected in the first half of 2022

 

   

Genentech and Roivant partnered programs continue to progress

 

   

As of December 31, 2021, cash and cash equivalents were €197.6 million compared to €146.9 million as of December 31, 2020, with an anticipated cash runway into the second half of 2023

 

   

Conference call and webcast are scheduled for March 31, 2022, at 8:30 a.m. EDT

Heidelberg, Germany, March 31, 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, today reported financial results for the year ended December 31, 2021, and provided an update on clinical and corporate progress.

“Over the course of 2021 we continued to make strong progress with each of our ICE® candidates by executing on our clinical development objectives,” said Dr. Adi Hoess, CEO of Affimed. “In particular, the clinical data from AFM13 pre-complexed with cord blood-derived natural killer (NK) cells in relapsed/refractory CD30+ lymphomas demonstrated the broad potential of our ICE® platform. We are very encouraged by this data as this could significantly broaden the AFM13 market opportunity targeting CD30-positive Hodgkin, T cell, and potentially B cell lymphoma. Furthermore, we believe these results validate that our ICE® candidates can meaningfully enhance NK cell-driven efficacy in underserved cancer patients, and we look forward to the presentation of further data at AACR.


“With the establishment of the recommended phase 2 dose for AFM24, we have embarked on a broad development strategy investigating AFM24 as monotherapy and in two combination studies—one with atezolizumab and the second with SNK01 NK cells,“ Dr. Hoess continued.

“We spent a good portion of 2021 transforming our organization by growing our team of dedicated scientists and industry experts. This investment in acquiring the right resources and talent, as well as our strong cash position, will ensure that we continue to deliver and advance our programs in 2022 and beyond.”

Clinical Stage Program Updates

AFM13 (CD30/CD16A)

 

   

Affimed completed enrollment of its REDIRECT study (AFM13-202). The Company expects to report top-line data in the second half of 2022.

REDIRECT is a phase 2, registration-directed study of AFM13 monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL).

 

   

In December 2021, Affimed reported updated data from AFM13-104, the investigator sponsored trial (IST) led by The University of Texas MD Anderson Cancer Center investigating the combination of AFM13 pre-complexed with cord blood-derived natural killer cells followed by AFM13 monotherapy. The data reported findings for the first 19 patients enrolled in the study, including six patients treated at lower doses and 13 patients treated at the recommended phase 2 dose. There was impressive anti-tumor activity with a 100% objective response rate (ORR) and 38% complete response rate (CRR) at the RP2D after a single cycle of therapy.

Data of patients receiving two treatment cycles will be presented at the AACR Clinical Trials Plenary Session on April 10, 2022, by Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson. The presentation will also be included in the AACR Press Conference on April 10, 2022.

MD Anderson has initiated enrollment of patients into the phase 2 portion of the trial and the Food and Drug Administration (FDA) has approved an amendment to the AFM13-104 trial protocol to increase the patient population treated at the RP2D to 40 CD30-positive lymphoma patients including HL, TCL and BCL and allow for the treatment of patients with more than the two cycles of therapy, at the investigator’s discretion.

AFM24 (EGFR/CD16A)

 

   

For AFM24, an EGFR/CD16A ICE®, Affimed achieved a key milestone through the identification of the RP2D of 480 mg weekly dosing for the treatment of patients with EGFR-expressing solid tumors. The Company has initiated a broad development strategy intended to deliver the highest probability of success which includes three studies investigating various solid tumor indications.


   

In the monotherapy phase 1/2a clinical trial (AFM24-101), Affimed has initiated enrollment in the expansion phase at the RP2D. The expansion cohorts include patients with renal cell carcinoma, non-small cell lung cancer and colorectal cancer. Data from the dose escalation phase of the trial will be presented in a poster at the AACR 2022 meeting in April.

 

   

Enrollment was initiated in AFM24-102, the phase 1/2a combination study of AFM24 with the anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®) to treat patients with non-small cell lung cancer, gastric and gastroesophageal junction adenocarcinoma and pancreatic/hepatocellular/biliary tract cancer patients.

 

   

Enrollment was also initiated in AFM24-103, the phase 1/2a combination study of AFM24 with the SNK01 NK cells to treat patients with non-small cell lung cancer, squamous cell carcinoma of the head and neck, and colorectal cancer.

 

   

Affimed expects to report initial data from the AFM24 studies during 2022.

Preclinical Programs

AFM28 (CD123/CD16A)

 

   

Preclinical candidate AFM28, developed on the Company’s proprietary ROCK® platform, is a bispecific, tetravalent ICE® that targets CD16A on NK cells and macrophages, as well as CD123 on leukemic cells and leukemic stem cells that are prevalent in acute myeloid leukemia (AML).

 

   

Preclinical data demonstrates that AFM28 induces tumor cell lysis more potently than conventional anti-CD123 antibodies, in particular at low CD123 expression. Further, AFM28 shows a 100-fold more potent NK cell activation in an ex vivo analysis, compared to Fc-enhanced IgG1 antibodies. In a preclinical toxicology study in cynomolgus monkeys, AFM28 was safe and well-tolerated and exhibited the expected pharmacodynamic activity suggesting a good safety profile and the potential to eliminate CD123+ cells in vivo.

 

   

An IND is planned to be submitted in the first half of 2022 and clinical investigation of AFM28 is planned to start in second half of 2022.

Pre-clinical pipeline

 

   

Affimed is continuing the generation of several novel ICE® molecules derived from its proprietary ROCK® platform.

AFM32 and other partnered pre-clinical programs

 

   

Genentech and Roivant partnered programs continue to progress and future updates will be provided at their discretion.

Full Year 2021 Financial Highlights

Affimed’s consolidated financial statements are prepared in accordance with IFRS as issued by the International Accounting Standard Board (IASB). The consolidated financial statements are presented in euros, which is the Company’s functional and presentation currency.


As of December 31, 2021, cash and cash equivalents totaled €197.6 million compared to €146.9 million as of December 31, 2020. 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, 2021, was €86.6 million compared to €19.4 million for the year ended December 31, 2020. The increase is due to higher cash expenditure for research and development as well as general and administrative activities. In addition, net cash used in operating activities in 2020 included cash received from an initial upfront payment and committed funding of €33.3 million (USD 40 million) from the Roivant collaboration, as well as a milestone payment received pursuant to the Genentech collaboration.

Total revenue for the year ended December 31, 2021, was €40.4 million compared with €28.4 million for the year ended December 31, 2020.

Revenue for the years ended December 31, 2021, and December 31, 2020, predominantly relate to the Genentech and Roivant collaboration. Collaboration revenue for the year ended December 31, 2021, was €39.3 million, with €21.6 million coming from the Genentech collaboration and €17.7 million from the Roivant collaboration. Collaboration revenue for year ended December 31, 2020, was €27.8 million, with €26.2 million from the Genentech collaboration and €1.4 million from the Roivant collaboration.

Research and development expenses for the year ended December 31, 2021, increased 63 percent from €50.0 million for the year ended December 31, 2020, to €81.5 million for the year ended December 31, 2021. The increase was primarily due to increased expenses for AFM24 and AFM28 including costs to produce clinical trial material, an increase in costs associated with other early-stage programs and infrastructure, and an increase in share-based payment expenses.

General and administrative expenses for the year ended December 31, 2021, increased 77 percent, from €13.7 million for the year ended December 31, 2020, to €24.2 million in the year ended December 31, 2021. The increase predominately relates to higher share-based payment expenses in 2021, higher premiums for D&O liability insurance, and higher consulting expenses.

Net finance income for the year ended December 31, 2021, was €6.5 million compared to net finance costs of €6.6 million for the year ended December 31, 2020. Net finance income/costs is largely due to foreign exchange gains/losses related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and Euro during the year.

Net loss for the year ended December 31, 2021, was €57.5 million, or €0.48 per common share compared with a net loss of €41.4 million, or €0.50 per common share, for the year ended December 31, 2020.

The weighted number of common shares outstanding for the year ended December 31, 2021, was 119.5 million.


Additional information regarding these results will be included in the notes to the consolidated financial statements as of December 31, 2021, included in Affimed’s filings 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.

Conference Call and Webcast Information

Affimed will host a conference call and webcast March 31, 2022, at 8:30 a.m. EDT to discuss full year 2021 financial results and recent corporate developments. The conference call will be available via phone and webcast.

To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference passcode 6590614 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/.

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, AFM28 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 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, the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict 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.

Alexander Fudukidis

Director, Head of Investor Relations

E-Mail: a.fudukidis@affimed.com

Tel.: +1 (917) 436-8102


Affimed N.V.

Consolidated statements of comprehensive income / (loss)

(in € thousand)

 

     2021     2020     2019  

Revenue

     40,366       28,360       21,391  

Other income - net

     1,310       626       290  

Research and development expenses

     (81,488     (49,989     (43,791

General and administrative expenses

     (24,218     (13,715     (10,266
  

 

 

   

 

 

   

 

 

 

Operating loss

     (64,030     (34,718     (32,376

Finance income / (costs) - net

     6,509       (6,647     15  
  

 

 

   

 

 

   

 

 

 

Loss before tax

     (57,521     (41,365     (32,361

Income taxes

     (2     (1     (4
  

 

 

   

 

 

   

 

 

 

Loss for the period

     (57,523     (41,366     (32,365
  

 

 

   

 

 

   

 

 

 

Other comprehensive (loss) income /

      

Items that will not be reclassified to profit or loss

Equity investments at fair value OCI - net change in fair value

     (7,693     (242     (632
  

 

 

   

 

 

   

 

 

 

Other comprehensive (loss) income /

     (7,693     (242     (632
  

 

 

   

 

 

   

 

 

 

Total comprehensive loss

     (65,216     (41,608     (32,997
  

 

 

   

 

 

   

 

 

 

Basic and diluted loss per share in € per share (undiluted = diluted)

     (0.48     (0.50     (0.50

Weighted number of common shares outstanding

     119,502,384       83,471,559       64,242,396  


Affimed N.V.

Consolidated statements of financial position

(in € thousand)

 

     December 31, 2021     December 31, 2020  

ASSETS

    

Non-current assets

    

Intangible assets

     1,607       1,718  

Leasehold improvements and equipment

     3,814       2,226  

Long-term financial assets

     12,348       20,042  

Right-of-use assets

     972       940  
  

 

 

   

 

 

 
     18,741       24,926  

Current assets

    

Cash and cash equivalents

     197,630       146,854  

Trade and other receivables

     4,809       2,439  

Inventories

     421       246  

Other assets

     3,534       1,260  
  

 

 

   

 

 

 
     206,394       150,799  

TOTAL ASSETS

     225,135       175,725  

EQUITY AND LIABILITIES

    

Equity

    

Issued capital

     1,234       983  

Capital reserves

     474,087       345,164  

Fair value reserves

     (5,973     1,720  

Accumulated deficit

     (333,397     (275,874
  

 

 

   

 

 

 

Total equity

     135,951       71,993  

Non-current liabilities

    

Borrowings

     17,060       231  

Contract liabilities

     7,209       35,992  

Lease liabilities

     368       482  
  

 

 

   

 

 

 

Total non-current liabilities

     24,637       36,705  

Current liabilities

    

Trade and other payables

     18,860       11,394  

Borrowings

     580       92  

Lease liabilities

     683       492  

Contract liabilities

     44,424       55,049  
  

 

 

   

 

 

 

Total current liabilities

     64,547       67,027  

TOTAL EQUITY AND LIABILITIES

     225,135       175,725  


Affimed N.V.

Consolidated statements of cash flows

(in € thousand)

 

     2021     2020     2019  

Cash flow from operating activities

      

Loss for the period

     (57,523     (41,366     (32,365

Adjustments for the period:

      

- Income taxes

     2       1       4  

- Depreciation and amortisation

     1,334       1,115       906  

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

     0       34       (5

- Share based payments

     11,820       3,381       2,469  

- Finance income / costs - net

     (6,509     6,647       (15
  

 

 

   

 

 

   

 

 

 
     (50,876     (30,188     (29,006

Change in trade and other receivables

     (2,369     (1,065     33  

Change in inventories

     (175     50       (36

Change in other assets

     (2,274     (1,260     340  

Change in trade, other payables, provisions and contract liabilities

     (29,990     12,848       (791
  

 

 

   

 

 

   

 

 

 
     (85,684     (19,615     (29,460

Interest received

     0       294       628  

Paid interest

     (905     (78     (224

Paid income tax

     (2     (1     0  
  

 

 

   

 

 

   

 

 

 

Net cash used in operating activities

     (86,591     (19,400     (29,056

Cash flow from investing activities

      

Purchase of intangible assets

     (1,654     (9     (150

Purchase of leasehold improvements and equipment

     (2,196     (431     (1,324

Cash paid for investments in financial assets

     0       (8,101     (45,131

Cash received from maturity of financial assets

     0       16,547       50,945  
  

 

 

   

 

 

   

 

 

 

Net cash used for investing activities

     (3,850     8,006       4,340  

Cash flow from financing activities

      

Proceeds from issue of common shares, including exercise of share based payment awards

     124,460       74,195       31,373  

Transaction costs related to issue of common shares

     (7,412     (2,294     (2,215

Proceeds from borrowings

     17,500       0       562  

Transaction costs related to borrowings

     (311     0       0  

Repayment of lease liabilities

     (564     (521     (405

Repayment of borrowings

     (92     (2,128     (3,277
  

 

 

   

 

 

   

 

 

 

Cash flow from financing activities

     133,581       69,252       26,038  
  

 

 

   

 

 

   

 

 

 

Exchange-rate related changes of cash and cash equivalents

     7,636       (6,238     (917

Net changes to cash and cash equivalents

     43,140       57,858       1,322  

Cash and cash equivalents at the beginning of the period

     146,854       95,234       94,829  
  

 

 

   

 

 

   

 

 

 

Cash and cash equivalents at the end of the period

     197,630       146,854       95,234  
  

 

 

   

 

 

   

 

 

 


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, 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 loss

           (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 loss

           (242       (242
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance as of December 31, 2020

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

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance as of January 1, 2021

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

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Issue of common shares

     240        114,197            114,437  

Exercise of share-based payment awards

     11        2,906            2,917  

Equity-settled share-based payment awards

        11,820            11,820  

Loss for the period

             (57,523     (57,523

Other comprehensive loss

           (7,693       (7,693
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance as of December 31, 2021

     1,234        474,087        (5,973     (333,397     135,951