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, 2018

 

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): ☐

 

 

 

 

 

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 20, 2018.

 

 

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 Affimed N.V. Press Release dated March 20, 2018

 

 

 

 

 

 

 

 

 

FOR IMMEDIATE RELEASE

 

Affimed Reports Financial Results for Fourth Quarter

and Year End 2017

 

Heidelberg, Germany, March 20, 2018 - Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, today reported financial results for the quarter and year ended December 31, 2017.

 

“Our approach of harnessing the power of innate and adaptive immunity showed its first clinical potential in 2017 and early 2018 with very encouraging data becoming available for AFM13 as monotherapy in Hodgkin and CD30-positve lymphomas as well as for AFM13 in combination with Keytruda in Hodgkin lymphoma,” said Dr. Adi Hoess, CEO of Affimed. “In addition, we were able to hire outstanding executive managers with Leila Alland as CMO and Wolfgang Fischer as COO, who will be instrumental to the further development of our pipeline towards marketed therapies."

 

Corporate Updates

 

·In 2017 and early 2018, Affimed has made important additions to its management team. The Company entered into an agreement with Leila Alland, M.D. who will join Affimed as CMO effective March 26, 2018. Dr. Leila Alland brings to the Company more than 20 years of oncology experience, having held leadership roles in drug development at Tarveda Therapeutics, AstraZeneca, Bristol-Myers Squibb and Novartis. Further strengthening Affimed’s U.S. presence, Dr. Alland will be based in the Company’s New York location along with Cassandra Choe-Juliak, M.D., Vice President, Clinical U.S. and Denise Mueller, Head of Commercial Strategy and Business Development of Affimed.

 

 

 

·In September 2017, Dr. Wolfgang Fischer, former Global Head of Program and Project Management of Sandoz Biopharmaceuticals (Novartis Group) joined Affimed as Chief Operating Officer (COO). Dr. Fischer has over 20 years of R&D experience with a focus on oncology, immunology and pharmacology, as well as a proven track record in drug development.

 

·In February 2018, Affimed completed an underwritten public offering on the Nasdaq Global Market, raising a total of approximately $24.5 million (€19.7 million) in net proceeds. Proceeds from this transaction, together with existing cash on the balance sheet, are expected to fund operations, including clinical development and early development activities, at least until the fourth quarter of 2019.

 

Pipeline Updates

 

NK-cell engager programs

·Enrollment has been completed into Affimed’s Phase 1b combination study of AFM13, a CD30/CD16A-targeting NK cell engager, with Merck’s Keytruda® (pembrolizumab) in relapsed/refractory Hodgkin lymphoma (r/r HL) and treatment is ongoing. A total of 24 patients are being treated at the highest AFM13 dose level. In February 2018, Affimed presented interim data from a total of 9 patients in this cohort, demonstrating that AFM13 in combination with Keytruda® is well-tolerated, with a 3-month objective response rate (ORR) of 89% comparing favorably to historical ORR of anti-PD-1 antibodies as monotherapy in a similar patient population (58-63%). Furthermore, 4 out of 9 patients (44%) showed complete metabolic responses, compared to complete response rates of 9-22% reported for anti-PD-1 monotherapy in a similar patient population. Affimed expects full 3-month data by mid-year 2018 and intends to provide regular updates at scientific or medical conferences.

 

·Affimed is supporting an investigator-sponsored translational Phase 1b/2a study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation led by Columbia University. The study is designed to allow for serial cutaneous biopsies, thereby enabling assessment of NK cell biology and tumor cell killing within the tumor microenvironment. The second cohort has been fully enrolled and recruitment into the third cohort is ongoing. In February 2018, the Company reported an analysis of the first dose cohort (3 patients dosed at 1.5 mg/kg), demonstrating that AFM13 could be safely administered and showed therapeutic activity as a single agent, with an ORR of 66% (2 out of 3 patients). One complete response, one partial response and one stable disease were observed, as determined by global response score. These early data confirm the single-agent activity observed in a previous Phase 2a trial, and further suggest a new opportunity for AFM13 in CD30-positive lymphoma.

 

 

 

·The Company’s investigator-sponsored Phase 2a monotherapy study of AFM13 in HL led by the German Hodgkin Study Group (GHSG) is open and recruiting, including patients pre-treated with both brentuximab vedotin (B.V.) and anti-PD1. In May 2017 Affimed reported data from a subset of patients enrolled under the original study protocol (minimum of 3 lines of treatment including B.V., anti-PD-1-naïve) suggesting that AFM13 is efficacious as single agent in this heavily pre-treated group of patients.

 

·In Affimed’s collaboration with The University of Texas MD Anderson Cancer Center (MDACC), evaluating the Company’s NK cell engager AFM13 in combination with MDACC’s NK cell product, preclinical research activities are progressing. These are intended to be followed by a Phase 1 clinical trial.

 

·Affimed has generated tetravalent bispecific NK cell engager product candidates for AFM24 (EGFR/CD16A) with different pharmacokinetic profiles. Differentiating from current EGFR-targeted therapeutics, the Company’s molecules are designed with the potential to widen the therapeutic window in solid tumor therapy and to address patient populations that are resistant to EGFR-targeting agents. Affimed anticipates completing IND-enabling studies by mid-year 2019.

 

·The NK cell engager AFM26 (BCMA/CD16A), is designed to address the medical need of eliminating minimal residual disease (MRD) in multiple myeloma. In particular, Affimed aims to leverage BCMA as a target in autologous stem cell transplant (ASCT)-eligible patients. Affimed is developing different tetravalent bispecific antibody formats and continues to advance its lead candidate in IND-enabling studies.

 

·Discovering and assessing additional opportunities to harness innate and adaptive immunity, Affimed recently published data in Cancer Immunology Research, together with its collaboration partner, the German Cancer Research Center (DKFZ). The Company presented evidence of AFM13 sensitizing NK cells to IL-2 and/or IL-15 stimulation. In this study, after exposure to AFM13, the NK cells showed enhanced IL-2- and IL-15-mediated proliferation and cytotoxicity. These data corroborate initial findings the Company had presented at the AACR Annual Meeting in April 2017 and support the approach of combining Affimed’s NK cell engagers with IL-2- or IL-15 to potentially achieve deeper clinical responses.

 

T-cell engager programs

·Affimed is conducting two clinical Phase 1 dose-escalation trials with AFM11, a CD3/CD19-targeting tetravalent bispecific T cell engager, in patients with r/r acute lymphocytic leukemia (ALL) and with r/r non-Hodgkin lymphoma (NHL), respectively. In the Company’s NHL study, the third dose cohort has recently been completed and Affimed’s ALL trial is currently recruiting patients into the fifth dose cohort.

 

·Amphivena Therapeutics, Inc. continues to recruit patients into its first-in-human Phase 1 dose escalation study of AMV564 in r/r acute myeloid leukemia (AML). Amphivena also plans to launch a Phase 1 clinical study in patients with myelodysplastic syndrome (MDS) and is

 

 

 

exploring the utility of AMV564 in solid tumors. AMV564 is a CD33/CD3-specific T cell engagers based on Affimed’s technology platform. Affimed owns approximately 18.5% of Amphivena (fully diluted).

 

Financial Highlights

(Figures for the fourth quarter of 2017 and 2016 represent unaudited figures)

 

Cash and cash equivalents and financial assets totaled €39.8 million as of December 31, 2017 compared to €44.9 million as of December 31, 2016. Affimed was able to fund its operational expenses in 2017 with existing cash, the issuance of new shares and the usage of an additional loan tranche.

 

Net cash used in operating activities for the fourth quarter of 2017 was €4.9 million compared to €6.6 million for the fourth quarter of 2016. Net cash used in operating activities was €25.5 million for the twelve months ended December 31, 2017 compared to €32.1 million for the twelve months ended December 31, 2016. The year-over-year decrease was primarily related to lower cash expenditure for research and development (R&D) in connection with our development and collaboration programs.

 

Revenue for the fourth quarter of 2017 was €0.6 million compared to €1.4 million for the fourth quarter of 2016. Revenue for the full year 2017 was €2.0 million compared to €6.3 million for the full year 2016. Revenue for the full year and the fourth quarter 2017 was primarily derived from AbCheck services. Revenue for the full year 2016 related to a large extent to Affimed’s collaborations with Amphivena and LLS while revenue for the fourth quarter 2016 was derived from AbCheck services.

 

R&D expenses for the fourth quarter of 2017 were €4.6 million compared to €5.7 million for the fourth quarter of 2016. For the full year 2017, R&D expenses were €21.5 million compared to €30.2 million for the full year 2016. The decrease was primarily related to lower expenses for AFM13 related CMC activities, preclinical programs and infrastructure.

 

G&A expenses for the fourth quarter of 2017 were €1.9 million compared to €2.1 million for the fourth quarter of 2016. For the full year 2017, G&A expenses were slightly lower with €8.0 million compared to €8.3 million for the full year 2016.

 

Net loss for the fourth quarter of 2017 was €6.4 million, or €0.14 per common share, compared to a net loss of €5.4 million, or €0.19 per common share, for the fourth quarter of 2016. Net loss for the full year 2017 was €30.2 million, or €0.69 per common share, compared to a net loss of €32.2 million, or €0.97 per common share, for the full year 2016. The decrease in net loss for the full year 2017 was primarily related to decreased spending on R&D for AFM13 related CMC

 

 

 

activities, preclinical programs and infrastructure, partially offset by lower revenue and higher finance costs. Additional information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2017 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 SEC.

 

Including the proceeds from the equity offering in February 2018, the Company’s operations, including clinical development and early development activities, are expected to be funded at least until the fourth quarter of 2019.

 

Note on IFRS Reporting Standards

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

 

Conference Call and Webcast Information

Affimed’s management will host a conference call to discuss the company’s financial results and recent corporate developments today at 8:30 a.m. ET. A webcast of the conference call can be accessed in the “Events” section on the “Investors & Media” page of the Affimed website at http://www.affimed.com/events.php. A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived on the Affimed website for 30 days following the call.

 

About Affimed N.V.

Affimed (Nasdaq: AFMD) engineers targeted immunotherapies, seeking to cure patients by harnessing the power of innate and adaptive immunity (NK and T cells). We are developing single and combination therapies to treat cancers and other life-threatening diseases. 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, 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.

 

Contact:

Anca Alexandru, Head of Communications, EU IR

Phone: +49 6221 64793341

E-Mail: a.alexandru@affimed.com, IR@affimed.com

 

 

 

AFFIMED N.V.

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

 

Affimed N.V.

Consolidated statements of comprehensive loss (in € thousand)

 

   2015  2016  2017
Revenue   7,562    6,314    2,010 
                
Other income – net   651    145    205 
Research and development expenses   (22,008)   (30,180)   (21,489)
General and administrative expenses   (7,548)   (8,323)   (7,986)
                
Operating loss   (21,343)   (32,044)   (27,260)
                
Finance income / (costs) – net   1,104    (230)   (2,983)
                
Loss before tax   (20,239)   (32,274)   (30,243)
                
Income taxes   0    58    20 
                
Loss for the period   (20,239)   (32,216)   (30,223)
                
Total comprehensive loss   (20,239)   (32,216)   (30,223)
                
                

Loss per share in € per share

(undiluted = diluted)

   (0.71)   (0.97)   (0.69)

 

 

 

Affimed N.V.

Consolidated statements of financial position (in € thousand)

 

   December 31, 2016  December 31, 2017
       
       
ASSETS          
Non-current assets          
           
Intangible assets   55    65 
Leasehold improvements and equipment   822    1,113 
    877    1,178 
           
Current assets          
           
Inventories   197    241 
Trade and other receivables   2,255    1,102 
Other assets   516    800 
Financial assets   9,487    0 
Cash and cash equivalents   35,407    39,837 
    47,862    41,980 
           
TOTAL ASSETS   48,739    43,158 
           
EQUITY AND LIABILITIES          
Equity          
           
Issued capital   333    468 
Capital reserves   190,862    213,778 
Accumulated deficit   (152,444)   (182,667)
Total equity   38,751    31,579 
           
Non-current liabilities          
           
Borrowings   3,617    4,086 
Total non-current liabilities   3,617    4,086 
           
Current liabilities          
           
Trade and other payables   5,323    4,180 
Borrowings   973    3,083 
Deferred revenue   75    230 
Total current liabilities   6,371    7,493 
           
TOTAL EQUITY AND LIABILITIES   48,739    43,158 

 

 

 

Affimed N.V.

Consolidated statements of cash flows (in € thousand)

 

   2015  2016  2017
Cash flow from operating activities               
Loss for the period   (20,239)   (32,216)   (30,223)
Adjustments for the period:               
- Income taxes   0    (58)   (20)
- Depreciation and amortization   336    369    351 
- Net gain from disposal of leasehold improvements and equipment   0    0    (19)
- Share based payments   2,220    3,545    1,943 
- Finance income / costs – net   (1,104)   230    2,983 
    (18,787)   (28,130)   (24,985)
Change in trade and other receivables   24    (1,311)   1,140 
Change in inventories   (29)   31    (44)
Change in other assets   (452)   (64)   (399)
Change in trade, other payables and deferred revenue   1,253    (2,177)   (1,018)
Cash used in operating activities   (17,991)   (31,651)   (25,306)
Interest received   10    102    106 
Paid interest   (554)   (578)   (349)
Net cash used in operating activities   (18,535)   (32,127)   (25,549)
Cash flow from investing activities               
Purchase of intangible assets   (28)   (21)   (43)
Purchase of leasehold improvements and equipment   (249)   (238)   (625)
Cash received from the sale of leasehold improvements
and equipment
   0    0    35 
Cash paid for investments in convertible note and warrants   0    0    (296)
Cash paid for investments in financial assets   0    (27,037)   (13,084)
Cash received from maturity of financial assets   0    18,147    22,063 
Net cash used for investing activities   (277)   (9,149)   8,050 
Cash flow from financing activities               
Proceeds from issue of common shares   56,615    6    23,123 
Transaction costs related to issue of common shares   (3,117)   0    (1,648)
Proceeds from borrowings   0    5,000    2,500 
Transaction costs related to borrowings   0    (105)   (11)
Repayment of borrowings   0    (5,137)   (167)
Cash flow from financing activities   53,498    (236)   23,797 
Exchange-rate related changes of cash and cash equivalents   2,329    179    (1,867)
Net changes to cash and cash equivalents   34,686    (41,512)   6,297 
Cash and cash equivalents at the beginning of the period   39,725    76,740    35,407 
Cash and cash equivalents at the end of the period   76,740    35,407    39,837 

 

 

 

Affimed N.V. 

Consolidated statements of changes in equity (in € thousand)

 

    Issued capital    Capital reserves    Accumulated deficit    

Total

equity

 
                     
Balance as of January 1, 2015   240    131,544    (99,989)   31,795 
Issue of common shares   91    52,463         52,554 
Exercise of share based payment awards   2    942         944 
Equity-settled share based payment award        2,220         2,220 
Loss for period             (20,239)   (20,239)
Balance as of December 31, 2015   333    187,169    (120,228)   67,274 
                     
Balance as of January 1, 2016   333    187,169    (120,228)   67,274 
Issue of common shares1   0    6         6 
Equity-settled share based
payment awards
        3,545         3,545 
Issue of warrant note (loan Silicon Valley Bank)        142         142 
Loss for the period             (32,216)   (32,216)
Balance as of December 31, 2016   333    190,862    (152,444)   38,751 
                     
Balance as of January 1, 2017   333    190,862    (152,444)   38,751 
Issue of common shares   135    20,922         21,057 
Equity-settled share based payment awards        1,943         1,943 
Issue of warrant note (loan Silicon Valley Bank)        51         51 
Loss for the period             (30,223)   (30,223)
Balance as of December 31, 2017   468    213,778    (182,667)   31,579 

1Issue of 3,341 shares

 

 

 

Affimed N.V. 

Consolidated statements of comprehensive loss (in € thousand)

 

  

Q4 2016

(unaudited)

 

Q4 2017

(unaudited)

       
       
Revenue   1,371    636 
           
Other income – net   2    4 
Research and development expenses   (5,724)   (4,608)
General and administrative expenses   (2,084)   (1,895)
           
Operating (loss)   (6,435)   (5,863)
           
Finance income / (costs) - net   953    (558)
           
Loss before tax   (5,482)   (6,421)
           
Income taxes   60    0 
           
Loss for the period   (5,422)   (6,421)
           
Total comprehensive loss   (5,422)   (6,421)
           
           
           
Loss per share in € per share   (0.19)   (0.14)
(undiluted = diluted)          

 

 

 

Affimed N.V.

Consolidated statements of cash flows (in € thousand)

 

  

Q4 2016

(unaudited)

 

Q4 2017 

(unaudited) 

Cash flow from operating activities          
Loss for the period   (5,422)   (6,421)
Adjustments for the period:          
- Income taxes   (60)   0 
- Depreciation and amortization   76    94 
- Share based payments   826    449 
- Finance income / costs - net   (953)   558 
           
    (5,533)   (5,320)
Change in trade and other receivables   87    450 
Change in inventories   56    41 
Change in other assets   87    (6)
Change in trade, other payables and deferred revenue   (1,097)   26 
           
Cash used in operating activities   (6,400)   (4,809)
Interest received   42    58 
Paid interest   (223)   (120)
Net cash used in operating activities   (6,581)   (4,871)
           
Cash flow from investing activities          
Purchase of intangible assets   0    (17)
Purchase of leasehold improvements and equipment   (44)   (80)
Cash paid for investments in convertible note and warrants   0    (296)
Cash paid for investments in financial assets   51    30 
Cash received from maturity of financial assets   4,611    8,638 
Net cash used for investing activities   4,618    8,275 
           
Cash flow from financing activities          
Proceeds from issue of common shares   6    3,882 
Transaction costs related to issue of common shares   0    (124)
Proceeds from borrowings   5,000    0 
Transaction costs related to borrowings   (105)   0 
Repayment of borrowings   (4,058)   (167)
Cash flow from financing activities   843    3,591 
           
Exchange-rate related changes of cash and cash equivalents   834    (501)
Net changes to cash and cash equivalents   (1,120)   6,995 
Cash and cash equivalents at the beginning of the period   35,693    33,343 
Cash and cash equivalents at the end of the period   35,407    39,837