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 November, 2020

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):  ☐

 

 

 


INCORPORATION BY REFERENCE

Exhibits 99.1 and 99.2 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333-198812) of Affimed N.V. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

Exhibit 99.3 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, November 10, 2020.

 

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. Unaudited Condensed Consolidated Interim Financial Statements as of September 30, 2020.
99.2    Affimed N.V. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
99.3    Affimed N.V. Press Release dated November 10, 2020.
EX-99.1

Exhibit 99.1

Affimed N.V.

Unaudited consolidated statements of comprehensive income/(loss) (in € thousands)

 

           

For the three months

ended September 30

   

For the nine months

ended September 30

 
     Note      2020     2019     2020     2019  

Revenue

     3        10,545       2,103       18,614       17,464  

Other income – net

        102       49       130       332  

Research and development expenses

        (10,101     (11,721     (33,247     (31,253

General and administrative expenses

        (3,455     (2,790     (9,586     (7,566
     

 

 

   

 

 

   

 

 

   

 

 

 

Operating income / (loss)

        (2,909     (12,359     (24,089     (21,023

Finance income / (costs) – net

     4        (3,057     1,475       (2,404     1,655  
     

 

 

   

 

 

   

 

 

   

 

 

 

Loss before tax

        (5,966     (10,884     (26,493     (19,368

Income taxes

        0       0       0       (4
     

 

 

   

 

 

   

 

 

   

 

 

 

Loss for the period

        (5,966     (10,884     (26,493     (19,372
     

 

 

   

 

 

   

 

 

   

 

 

 

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

     5        (139     (555     (129     (531
     

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income / (loss)

        (139     (555     (129     (531
     

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive loss

        (6,105     (11,439     (26,622     (19,903
     

 

 

   

 

 

   

 

 

   

 

 

 

Loss per share in € per share
(undiluted = diluted)

        (0.07     (0.17     (0.33     (0.31

Weighted number of common shares outstanding

        86,030,878       62,443,550       80,490,155       62,437,673  

The Notes are an integral part of these consolidated financial statements.


Affimed N.V.

Consolidated statements of financial position (in € thousands)

 

            September 30, 2020     December 31, 2019  
     Note      (unaudited)        

ASSETS

       

Non-current assets

       

Intangible assets

        93       137  

Leasehold improvements and equipment

        2,305       2,291  

Long term financial assets

     5        3,064       3,193  

Right-of-use assets

        1,084       824  
     

 

 

   

 

 

 
        6,546       6,445  

Current assets

       

Cash and cash equivalents

        89,656       95,234  

Financial assets

     6        7,687       8,902  

Trade and other receivables

        2,552       1,482  

Inventories

        410       296  

Other assets

        1,087       0  
     

 

 

   

 

 

 
        101,392       105,914  

TOTAL ASSETS

        107,938       112,359  

EQUITY AND LIABILITIES

       

Equity

       

Issued capital

        883       762  

Capital reserves

        305,301       270,451  

Fair value reserves

        1,833       1,962  

Accumulated deficit

        (261,001     (234,508
     

 

 

   

 

 

 

Total equity

     7        47,016       38,667  

Non-current liabilities

       

Borrowings

     10        207       278  

Contract liabilities

        15,203       37,961  

Lease liabilities

        332       272  
     

 

 

   

 

 

 

Total non-current liabilities

        15,742       38,511  

Current liabilities

       

Trade and other payables

        8,123       10,674  

Provisions

     9        479       517  

Borrowings

     10        1,070       2,105  

Lease liabilities

        779       532  

Contract liabilities

        34,729       21,353  
     

 

 

   

 

 

 

Total current liabilities

        45,180       35,181  

TOTAL EQUITY AND LIABILITIES

        107,938       112,359  

The Notes are an integral part of these consolidated financial statements.


Affimed N.V.

Unaudited consolidated statements of cash flows (in € thousands)

 

         

For the nine months ended

September 30

 
     Note    2020     2019  

Cash flow from operating activities

       

Loss for the period

        (26,493     (19,372

Adjustments for the period:

       

- Income taxes

        0       4  

- Depreciation and amortization

        821       648  

- Net gain from disposal of leasehold improvements and equipment

        0       (9

- Share based payments

   8      2,348       1,981  

- Finance income / costs – net

   4      2,404       (1,655
     

 

 

   

 

 

 
        (20,920     (18,403

Change in trade and other receivables

        (1,174     458  

Change in inventories

        (114     (70

Change in other assets

        (1,087     (1,104

Change in trade, other payables, provisions and contract liabilities

        (12,053     (11,727
     

 

 

   

 

 

 

Cash used in operating activities

        (35,348     (30,846

Interest received

        299       413  

Paid interest

        (81     (180
     

 

 

   

 

 

 

Net cash used in operating activities

        (35,130     (30,613

Cash flow from investing activities

       

Purchase of intangible assets

        (8     (143

Purchase of leasehold improvements and equipment

        (352     (926

Cash paid for investments in financial assets

        (8,101     (39,733

Cash received from maturity of financial assets

        9,088       38,270  
     

 

 

   

 

 

 

Net cash used for investing activities

        627       (2,532

Cash flow from financing activities

       

Proceeds from issue of common shares

        33,846       26  

Transaction costs related to issue of common shares

        (1,134     0  

Proceeds from borrowings

        0       562  

Repayment of lease liabilities

        (386     (299

Repayment of borrowings

   10      (1,151     (2,339
     

 

 

   

 

 

 

Cash flow from financing activities

        31,175       (2,050
     

 

 

   

 

 

 

Exchange-rate related changes of cash and cash equivalents

        (2,250     361  

Net changes to cash and cash equivalents

        (3,328     (35,195

Cash and cash equivalents at the beginning of the period

        95,234       94,829  
     

 

 

   

 

 

 

Cash and cash equivalents at the end of the period

        89,656       59,995  
     

 

 

   

 

 

 

The Notes are an integral part of these consolidated financial statements.


Affimed N.V.

Unaudited consolidated statements of changes in equity (in € thousands)

 

     Note      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  
     

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Exercise of share based payment awards

           26            26  

Equity-settled share based payment awards

     8           1,981            1,981  

Loss for the period

                (19,372     (19,372

Other comprehensive income

              (531       (531
     

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance as of September 30, 2019

        624        241,062        2,063       (221,516     22,233  
     

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance as of January 1, 2020

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

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Issue of common shares

        121        32,502            32,623  

Equity-settled share based payment awards

     8           2,348            2,348  

Loss for the period

                (26,493     (26,493

Other comprehensive income

              (129       (129
     

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance as of September 30, 2020

        883        305,301        1,833       (261,001     47,016  
     

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

The Notes are an integral part of these consolidated financial statements.


1.

Reporting entity

Affimed N.V. is a Dutch company with limited liability (naamloze vennootschap) and has its corporate seat in Amsterdam, the Netherlands. The consolidated financial statements are comprised of Affimed N.V., and its controlled (and wholly owned) subsidiaries Affimed GmbH, Heidelberg, Germany, AbCheck s.r.o., Plzen, Czech Republic, Affimed Inc., Delaware, USA and AbCheck Inc., Delaware, USA (together “Affimed”, the “Company” or the “Group”).

Affimed is a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. The Group’s product candidates represent an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. Affimed has its own research and development programs, strategic collaborations and service contracts, pursuant to which Affimed is performing research services for third parties.

 

2.

Basis of preparation and changes to Group’s accounting policies

Statement of compliance

The interim financial statements for the three and nine months ended September 30, 2020 and 2019 have been prepared in accordance with IAS 34 Interim Financial Reporting. The interim financial statements do not include all the information and disclosures required in the annual financial statements, and should be read in conjunction with Affimed N.V.’s annual consolidated financial statements as of December 31, 2019.

The interim financial statements were authorized for issuance by the management board on November 10, 2020.

Critical judgments and accounting estimates

The preparation of the interim financial statements in conformity with IFRS requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.

In preparing these interim financial statements, the critical judgments made by management in applying the Company’s accounting policies were the same as those that applied to the consolidated financial statements as of and for the year ended December 31, 2019.

 


Functional and presentation currency

These interim financial statements are presented in Euro, which is the Company’s functional currency. All financial information presented in Euro has been rounded to the nearest thousand (abbreviated €) or million (abbreviated € million).

Significant accounting policies

The accounting policies applied by the Company in these interim financial statements are the same as those applied by the Company in its consolidated financial statements as of and for the year ended December 31, 2019 with the exception of new amendments to standards and new or amended interpretations applied for the first time as described below.

New standards and interpretations applied for the first time

The following amendments to standards and new or amended interpretations are effective for annual periods beginning on or after January 1, 2020, and have been applied in preparing these financial statements:

 

Standard/interpretation    Effective Date

Amendments to References to the Conceptional Framework

   January 1, 2020

Amendments to IAS 1 and IAS 8: Definition of Material

   January 1, 2020

Amendments to IFRS 9, IAS 39 and IFRS 7:

  

Interest Rate Benchmark Reform

   January 1, 2020

Amendments to IFRS 3 Business Combination

   January 1, 2020

Amendment to IFRS 16 Leases Covid 19-Related Rent Concessions

   June 1, 2020

None of the amendments to standards and new or amended interpretations had a material effect on the interim financial statements.

Fair Value Measurement

All assets and liabilities for which fair value is recognized in the interim financial statements are classified in accordance with the following fair value hierarchy, based on the lowest level input parameter that is significant on the whole for fair value measurement:

 

   

Level 1 – Prices for identical assets or liabilities quoted in active markets (non-adjusted)

 

   

Level 2 – Measurement procedures, in which the lowest level input parameter significant on the whole for fair value measurement is directly or indirectly observable for on the market

 

   

Level 3 – Measurement procedures, in which the lowest level input parameter significant on the whole for fair value measurement is not directly or indirectly observable for on the market

 

6


The carrying amount of all trade and other receivables, certificates of deposit, cash and cash equivalents and trade and other payables is a reasonable approximation of the fair value and, therefore, information about the fair values of those financial instruments has not been disclosed. The measurement of the fair value of the shares held by the group and note disclosure for the fair value of a loan (financial liability) is based on level 2 measurement procedures (see notes 5 and 10).

New standards and interpretations not yet adopted

The following standards, amendments to standards and interpretations are effective for annual periods beginning after December 31, 2019 and have not been applied in preparing these consolidated financial statements.

 

Standard/interpretation    Effective Date  

Amendments to IAS 1 Presentation of Financial Statements:

  

Classification of Liabilities as Current or Non-current

     January 1, 2023  

Amendments to IFRS 3 Business Combinations

     January 1, 2022  

Amendments to IAS 16 Property, Plant and Equipment

     January 1, 2022  

Amendments to AS 37 Provisions, Contingent Liabilities and

  

Contingent Assets

     January 1, 2022  

Annual Improvements 2018-2020

     January 1, 2022  

Amendments to IFRS 9, IAS 39, IFRS 7, IFRS 4 and

  

IFRS 16 Interest Rate Benchmark Reform – Phase 2

     January 1, 2021  

 

3.

Revenue

Collaboration agreement The Leukemia & Lymphoma Society (LLS)

Affimed is party to a collaboration with LLS to fund the development of specific product candidates (immune cell engagers). Under the terms of the agreement, LLS has agreed to contribute up to $4.4 million contingent upon the achievement of certain milestones.

 

7


In the event that the research and development is successful, Affimed must proceed with commercialization of the licensed product. If Affimed decides for business reasons not to continue the commercialization, Affimed must at its option either repay the amount funded or grant a license to LLS to enable LLS to continue with the development program. In addition, LLS is entitled to receive royalties from Affimed based on the Group’s future revenue from any licensed product, with the amount of royalties not to exceed three times the amount funded.

In June 2016, the research funding agreement with LLS was amended to reflect a shift to the development of combination therapeutic approaches so that the milestones now relate primarily to the development of a combination therapy.

During the nine months ended September 30, 2020, the Company recognized revenue totalling €0.1 million (2019: €0.0 million).

Collaboration with Genentech Inc.

In August 2018, Affimed entered into a strategic collaboration agreement with Genentech Inc., headquartered in South San Francisco, USA. Under the terms of the agreement Affimed will develop novel NK cell engager-based immunotherapeutics to treat multiple cancers. The Genentech agreement became effective at the beginning of October 2018. Affimed received $96.0 million (€83.2 million) in initial upfront and committed funding on October 31, 2018.

The Group recognized €10.5 million and €18.1 million as revenue during the three and nine months ended September 30, 2020 (2019: €1.9 million and €16.2 million). As of September 30, 2020, contract liabilities of €49.9 million (December 31, 2019: €59.3 million) will be recognized as revenue in subsequent periods.

Under the terms of the agreement, Affimed is eligible to receive up to an additional $5.0 billion over time, including payments upon achievement of specified development, regulatory and commercial milestones. Affimed is also eligible to receive royalties on any potential sales.

Research service agreements

The Group, through its subsidiary AbCheck s.r.o. has entered into certain research service agreements. These research service agreements provide for non-refundable upfront technology access research funding or capacity reservation fees and milestone payments. The Company recognized €0.0 million and €0.4 million as revenue in the three and nine months ended September 30, 2020 (2019: €0.2 million and €1.3 million).

 

8


Contract balances

The following table provides information about receivables and contract liabilities from contracts with customers.

 

     September 30, 2020      December 31, 2019  

Receivables

     0        204  

Contract liabilities

     49,932        59,314  

Amounts of €1,801 and €9,381 recognized in contract liabilities at the beginning of the period have been recognized as revenue during the three and nine months ended September 30, 2020.

The remaining performance obligations as of September 30, 2020 are approximately €49.9 million and are expected to be recognized as revenue to a large extent over the next two years.

Disaggregation of revenue

Geographic information

 

     Three months
ended
September 30,
2020
     Three months
ended
September 30,
2019
     Nine months
ended
September 30,
2020
     Nine months
ended
September 30,
2019
 

Revenue:

           

Germany

     0        0        75        0  

Europe

     0        155        2        1,232  

USA

     10,545        1,948        18,537        16,232  
  

 

 

    

 

 

    

 

 

    

 

 

 
     10,545        2,103        18,614        17,464  
  

 

 

    

 

 

    

 

 

    

 

 

 

Major service lines

 

     Three months
ended
September 30,
2020
     Three months
ended
September 30,
2019
     Nine months
ended
September 30,
2020
     Nine months
ended
September 30,
2019
 

Collaboration revenue

     10,539        1,948        18,255        16,232  

Service revenue

     6        155        359        1,232  
  

 

 

    

 

 

    

 

 

    

 

 

 
     10,545        2,103        18,614        17,464  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

9


Timing on revenue recognition

 

     Three months
ended
September 30,
2020
     Three months
ended
September 30,
2019
     Nine months
ended
September 30,
2020
     Nine months
ended
September 30,
2019
 

Point in time

     8,738        0        9,021        5,633  

Over time

     1,807        2,103        9,593        11,831  
  

 

 

    

 

 

    

 

 

    

 

 

 
     10,545        2,103        18,614        17,464  

 

4.

Finance income and finance costs

 

     Three months
ended
September 30,
2020
     Three months
ended
September 30,
2019
     Nine months
ended
September 30,
2020
     Nine months
ended
September 30,
2019
 

Interest SVB Loan Agreement

     (34      (106      (150      (389

Foreign exchange differences

     (3,033      1,425        (2,478      1,453  

Finance cost lease liability

     (11      (5      (24      (18

Other finance income/finance costs

     21        161        186        609  

Gain from the modification of SVB Loan Agreement (see note 10)

     0        0        62        0  
  

 

 

    

 

 

    

 

 

    

 

 

 

Finance income/costs - net

     (3,057      1,475        (2,404      1,655  
  

 

 

    

 

 

    

 

 

    

 

 

 

 

5.

Long term financial assets

The Company holds preferred shares in Amphivena recognized at their fair value of €3.1 million (December 31, 2019: €3.2 million). During the three and nine months ended September 30, 2020, the fair value decreased by €139 and €129 (2019: €555 and €531) due to exchange rate differences.

 

6.

Financial assets

As of September 30, 2020 and December 31, 2019, financial assets consisted of U.S. Dollar denominated certificates of deposit with original maturities of more than three months.

 

7.

Equity

As of September 30, 2020 the share capital of €883 (December 31, 2019: €762) is divided into 88,326,040 (December 31, 2019: 76,249,901) common shares with a par value of €0.01 per share.

 

10


In May 2020, the Company implemented an at-the-market (“ATM”) program providing for the sales over time of up to $50,000,000 of its common shares. As of September 30, 2020, the Company has issued approximately 11.8 million common shares under this ATM program, generating net proceeds of approximately €32.4 million.

In the Annual General Meeting of Affimed N.V. held on August 4, 2020 the structure of the authorised share capital was changed as cumulative shares were abolished. As of September 30, 2020, authorised share capital of the company amounts to €3,120 and is divided into 311,950,000 shares, each with a nominal value of €0.01 per share. As at , December 31, 2019, the authorized share capital consisted of 155,975,000 common shares and 155,975,000 cumulative preference shares, each with a par value of €0.01 per share.

 

8.

Share-based payments

In 2014, an equity-settled share-based payment program was established by Affimed N.V. (ESOP 2014). Under this program, the Company granted awards to certain members of the Management Board, the Supervisory Board, non-employee consultants and employees.

Share based payments with service condition

The majority of the awards vest in instalments over three years and can be exercised up to 10 years after the grant date. In the three and nine months ended September 30, 2020, the group granted 1,173,750 and 2,562,309 awards. 45,446 and 228,587 ESOP 2014 awards were cancelled or forfeited, and 42,598 and 239,605 options were exercised during the three and nine months ended September 30, 2020. As of September 30, 2020, 9,401,684 ESOP 2014 options (December 31, 2019: 7,307,567) were outstanding, and 5,816,467 awards (December 31, 2019: 4,773,840) had vested. The options outstanding as of September 30, 2020 had an exercise price in the range of $1.30 to $13.47.

 

11


Share based payments with market condition

On April 20, 2018, Affimed issued 240,000 options, of which each grant consists of three tranches that vest when the volume-weighted average share price (measured based on Affimed closing share prices over the preceding fifteen trading days) reaches a certain hurdle ($6.15, $8.20 and $10.25). Fair value of the awards at grant date amounts to €133 ($164 thousand) and the contractual life time of the options was two years. No options were exercisable and the term of the options has been expired.

Share based payment expense

In the three and nine months ended September 30, 2020, compensation expense of €938 and €2,348 was recognized affecting research and development expenses (€398 and €1,115) and general and administrative expenses (€540 and €1,233). In the three and nine months ended September 30, 2019, compensation expense of €814 and €1,981 was recognized affecting research and development expenses (€317 and €817) and general and administrative expenses (€497 and €1,164).

Fair value measurement

The fair value of options was determined using the Black-Scholes valuation model. The significant inputs into the valuation model of share based payment grants during the nine months ended September 30, 2020 and 2019 with service conditions are as follows (weighted average):

 

     September 30,
2020
    September 30,
2019
 

Fair value at grant date

   $ 2.34     $ 2.11  

Share price at grant date

   $ 3.16     $ 3.03  

Exercise price

   $ 3.16     $ 3.03  

Expected volatility

     93     82

Expected life

     5.86       5.83  

Expected dividends

     0.00       0.00  
  

 

 

   

 

 

 

Risk-free interest rate

     0.89     2.12
  

 

 

   

 

 

 

Expected volatility is estimated based on the observed daily share price returns of a peer group measured over a historic period equal to the expected life of the awards.

The risk-free interest rates are based on the yield to maturity of U.S. Treasury strips and German sovereign strips respectively (as best available indication for risk-free rates), for a term equal to the expected life, as measured as of the Grant Date.

9. Provisions

In 2019, the group recognized costs related to the termination of the AFM 11 program totalling to €1.4 million, whereof €0.9 million were already incurred in 2019. €0.5 million of estimated costs expected to be incurred in future periods were recognized in provisions as of September 30, 2020 (December 31, 2019: €0.5 million).

 

12


10. Borrowings

Silicon Valley Bank

On November 30, 2016, the Company entered into a loan agreement with Silicon Valley Bank (the “SVB loan”) which provides the Company with a senior secured term loan facility for up to €10.0 million, which agreement was amended in May 2017 to provide that such amount would be available in three tranches. In December 2016, the Company drew an initial tranche of €5.0 million and in May 2017, a second tranche of €2.5 million; the availability of a third tranche of €2.5 million expired in September 2017 with such amount remaining undrawn.

Finance costs comprise the interest rate of one-month EURIBOR plus an applicable margin of 5.5%, with a floor of 5.5%, related one-time legal and arrangement fees of €236 and a final payment fee equal to 10% of the total principal amount to be paid with the last instalment. Pursuant to the loan agreement, the Company also granted the lender 166,297 and 53,395 warrants with an exercise price of $2.00 and $2.30 per share, respectively. Each warrant can be used to purchase common shares of Affimed at the respective exercise price for a period of ten years from the date of grant. The fair value of the warrants of €192 less deferred taxes and transaction costs of €81 and €8, respectively, was recorded as an addition to capital reserves in the equity of Affimed. The fair value of the warrants was determined using the Black-Scholes-Merton valuation model, with an expected volatility of 75 to 80% and an expected exercise period of five years to exercise of the warrant. The contractual maturity of the warrants is ten years.

The loan is secured by a pledge of 100% of Company’s ownership interest in Affimed GmbH, all intercompany claims owed to Affimed N.V. by its subsidiaries, and collateral agreements for all bank accounts, inventory, trade receivables and other receivables of Affimed N.V. and Affimed GmbH recognized in the consolidated financial statements.

As of September 30, 2020 and December 31, 2019, the fair value of the liability did not differ significantly from its carrying amount (€977 and €2,013). Repayment started in December 2017 with amortized payments of principal and interest in equal monthly instalments. In April 2020, the Company agreed with Silicon Valley Bank to extend the original maturity date of May 31, 2020 by six months to November 30, 2020. The modification resulted in a gain of €62 recognized in finance income in the second quarter of 2020. As of September 30, 2020, €977 (December 31, 2019: €2,013) was classified as current liabilities.

UniCredit Leasing CZ

In April 2019, the Group entered into a loan agreement with UniCredit Leasing CZ for €562.

 

13


After an initial instalment of €127 in the second quarter of 2019, repayment is effected in monthly instalments of €8 until November 2023. As of September 30, 2020, an amount of €300 (December 31, 2019: €368) was outstanding, of which €93 was classified as current liabilities (December 31, 2019: €93). As of September 30, 2020, the fair value of the liability did not differ significantly from its carrying amount.

11. Related parties

The supervisory directors of Affimed N.V. received compensation for their services on the supervisory board of €86 and €267 (€79 and €274) in the three and nine months ended September 30, 2020 (2019), remuneration of managing directors and other key management personnel amounted to €799 and €1,997 (€668 and €2.082). The payments in the nine months ended September 30, 2020 include payments following the death of our former Chief Financial Officer, Florian Fischer, amounting to €120.

The Company recognized share-based payment expenses of €103 and €156 (€120 and €160) for supervisory directors and €528 and €1,249 (€452 and €1,175) for managing directors and other key management personnel in the three and nine months ended September 30, 2020 (2019).

The following table provides the outstanding balances for management and supervisory board remuneration.

 

     Outstanding balances  
     September 30,
2020
    

December

31, 2019

 

Adi Hoess

     0        5  

Wolfgang Fischer

     0        1  

Thomas Hecht

     16        26  

Berndt Modig

     2        9  

Ferdinand Verdonck

     10        11  

Ulrich Grau

     13        21  

Bernhard Ehmer

     16        20  

Mathieu Simon

     5        9  

Harry Welten

     5        0  

Annalisa Jenkins

     4        0  

 

14


12. Subsequent events

On October 6, 2020, AbCheck s.r.o. announced that it had been awarded a grant of up to €1.44 million over 3 years to support the further development of microfluidic technology for the discovery of rare therapeutic antibodies. This grant was awarded by the Ministry of Industry and Trade of the Czech Republic.

On October 20, 2020, we announced the signing of a clinical collaboration agreement with NKMax America. Pursuant to the collaboration, the companies plan to explore the combination of AFM24 and SNK01 in a first-in-human proof of concept (POC) trial in patients with EGFR-expressing tumors. The agreement follows a previous collaboration between the two companies in the preclinical setting to better understand the combined activity of their respective platforms. The results of the preclinical collaboration have shown substantive synergy between Affimed’s ICE® molecules and with both NKMax America’s autologous and cryopreserved allogeneic natural killer cell products.

On November 5, 2020, we announced the signing of a collaboration with Artiva Biotherapeutics. Inc. to assess pre-manufactured, cryopreserved therapeutics combining Artiva’s allogeneic NK Cell and Affimed’s ICE® platforms. The costs of manufacturing and preclinical assessments will be shared by both companies. The agreement provides for potential further development of selected combination products.

On November 9, 2020, we announced that we entered into a license and strategic collaboration agreement with a subsidiary of Roivant Sciences Ltd. (“Roivant”) to develop and commercialize novel ICE® molecules, including AFM32, in oncology. Under the terms of the agreement, we will receive $60 million in upfront consideration, comprised of $40 million in cash and pre-paid R&D funding, and $20 million of newly issued shares in Roivant Sciences Ltd. We are eligible to receive up to an additional $2 billion in milestones over time upon achievement of specified development, regulatory and commercial milestones, as well as tiered royalties on net sales.

 

15

EX-99.2

Exhibit 99.2

AFFIMED N.V.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This management’s discussion and analysis is designed to provide you with a narrative explanation of our financial condition and results of operations. We recommend that you read this in conjunction with our unaudited interim condensed consolidated financial statements for the three and nine month periods ended September 30, 2020 and 2019 included as Exhibit 99.1 to the Report on Form 6-K in which this discussion is included. We also recommend that you read “Item 4. Information on the Company” and our audited consolidated financial statements for fiscal year 2019, and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2019 (the “Annual Report”) filed with the U.S. Securities and Exchange Commission (the “SEC”).

Unless otherwise indicated or the context otherwise requires, all references to “Affimed” or the “company,” “we,” “our,” “ours,” “us” or similar terms refer to Affimed N.V. and its subsidiaries.

We prepare and report our consolidated financial statements and financial information in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (the “IASB”). None of our financial statements were prepared in accordance with generally accepted accounting principles in the United States. Our reporting currency is the Euro. We have made rounding adjustments to some of the figures included in this management’s discussion and analysis. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that precede them. Unless otherwise indicated, all references to currency amounts in this discussions and analysis are in euros.

Overview

We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. One of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy, or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings.

To date, we have financed our operations primarily through our public offerings of our common shares, private placements of equity securities, the incurrence of loans including convertible loans and through government grants and payments from our collaboration partners. Through September 30, 2020, we have raised an aggregate of approximately €292 million (gross proceeds) through the issuance of equity and incurrence of loans. To date, we have not generated any revenues from product sales or royalties. Based on our current plans, we do not expect to generate product or royalty revenues unless and until we or any collaboration partner obtain marketing approval for, and commercialize, any of our product candidates.

We have generated losses since we began our drug development operations in 2000. As of September 30, 2020, we had an accumulated deficit of €261.0 million.

Notwithstanding our collaborations with Genentech and Roivant and the income earned for the three and nine month periods ended September 30, 2020 and anticipated in the remainder of 2020, we expect to continue incurring losses as we continue our preclinical and clinical development programs, apply for marketing approval for our product candidates and, subject to obtaining marketing approval for our product candidates, build a marketing and sales team to commercialize our product candidates. Our profitability is dependent upon the successful development, approval, and commercialization of our product candidates and achieving a level of revenues adequate to support our cost structure. We may never achieve profitability, and unless and until we do, we will continue to need to raise additional cash. We intend to fund future operations through additional equity and debt financings, and we may seek additional capital through arrangements with strategic partners or from other sources.

In 2009, we formed AbCheck, our 100% owned, independently run antibody screening platform company, located in the Czech Republic. AbCheck is devoted to the generation and optimization of fully human antibodies. Its technologies include a naïve human antibody library combined with a phage and yeast display antibody library, a proprietary algorithm to optimize affinity, stability and manufacturing efficiency and a mass humanization technology to discover and optimize high-quality human antibodies. In addition to providing candidates for Affimed projects, AbCheck is recognized for its expertise in antibody discovery throughout the United States and Europe and has been working with globally active pharmaceutical and biotechnology companies such as Tusk Therapeutics, bluebird bio, Eli Lilly, Daiichi Sankyo, Pierre Fabre and others.

 

1


We have one U.S. subsidiary, Affimed Inc., with senior employees in finance, investor relations, business development, corporate strategy and clinical operations.

Recent Developments

The Company announced in early February 2020 that Dr. Florian Fischer, Chief Financial Officer (“CFO”) of Affimed, passed away. In June 2020, the Company announced the appointment of Angus Smith as Affimed’s new permanent CFO, completing Affimed’s leadership team. Mr. Smith started his employment on July 13, 2020 and is based out of Affimed’s New York office. In addition, the Company announced the employment of Dr. Andreas Harstrick as Chief Medical Officer, starting in March 2020, and of Dr. Arndt Schottelius as Chief Scientific Officer, effective April 2020.

In May 2020, the Company implemented an at-the-market (“ATM”) program providing for the sales over time of up to $50,000,000 of its common shares. The offering is conducted under the Company’s effective shelf registration statement on Form F-3 pursuant to a prospectus supplement and the entry into a sales agreement with Jefferies LLC. As of September 30, 2020, the Company has issued approximately 11.8 million common shares under the ATM program, generating net proceeds of approximately $36.7 million.

As circumstances around the COVID-19 pandemic continue to rapidly evolve, Affimed is continuously assessing possible effects on its clinical trials and adapting the risk mitigation measures it has implemented. Affimed is closely monitoring and adhering to relevant federal and local guidelines on COVID-19 to ensure the safety and health of its global workforce and help limit the spread of COVID-19, while maintaining business continuity. The Company has taken mitigation steps to ensure that drug supply and other trial-related materials are ready and available for the patients enrolled in its clinical trials. The Company continues to evaluate the potential impact of the COVID-19 pandemic on patient enrollment and site activation in its clinical studies. Timelines for clinical studies presented herein and in our press release for the third quarter of 2020 represent the Company’s best estimates as of the date hereof, but remain subject to change pending the resolution of the COVID-19 crisis.

At the Annual General Meeting held on August 4, 2020, the shareholders of Affimed approved all agenda items, including the reappointment of Supervisory Directors, Dr. Thomas Hecht and Ferdinand Verdonck and the appointment of new Supervisory Directors, Dr. Annalisa Jenkins and Harry Welten. In addition, the shareholders approved the reappointment of Managing Directors Dr. Adi Hoess and Dr. Wolfgang Fischer and the appointment of Dr. Arndt Schottelius, Dr. Andreas Harstrick and Angus Smith.

On October 6, 2020, AbCheck announced that it had been awarded a grant of up to €1.44 million over 3 years to support the further development of microfluidic technology for the discovery of rare therapeutic antibodies. This grant was awarded by the Ministry of Industry and Trade of the Czech Republic.

On October 6, 2020, we announced the dosing of the first patient in a Phase 1 clinical trial of cord blood-derived natural killer cells in combination with AFM13.

On October 20, 2020, we announced the signing of a clinical collaboration agreement with NKMax America. Pursuant to the collaboration, the companies plan to explore the combination of AFM24 and SNK01 in a first-in-human proof of concept (POC) trial in patients with EGFR-expressing tumors. The agreement follows a previous collaboration between the two companies in the preclinical setting to better understand the combined activity of their respective platforms. The results of the preclinical collaboration have shown substantive synergy between Affimed’s ICE® molecules and with both NKMax America’s autologous and cryopreserved allogeneic natural killer cell products.

On November 5, 2020, we announced the signing of a collaboration with Artiva Biotherapeutics. Inc. to assess pre-manufactured, cryopreserved therapeutics combining Artiva’s allogeneic NK Cell and Affimed’s ICE® platforms. The costs of manufacturing and preclinical assessments will be shared by both companies. The agreement provides for potential further development of selected combination products.

On November 9, 2020, we announced that we entered into a license and strategic collaboration agreement with a subsidiary of Roivant Sciences Ltd. (“Roivant”) to develop and commercialize novel ICE® molecules, including AFM32, in oncology. Under the terms of the agreement, we will receive $60 million in upfront consideration, comprised of $40 million in cash and pre-paid R&D funding, and $20 million of newly issued shares in Roivant Sciences Ltd. We are eligible to receive up to an additional $2 billion in milestones over time upon achievement of specified development, regulatory and commercial milestones, as well as tiered royalties on net sales.

Collaboration and License Agreements

There have been no material changes to our license agreements from those reported in “Item 4. Information on the Company—B. Business Overview—Collaborations” in the Annual Report. We have entered into new collaboration agreements described in “Recent Developments” above. A detailed description of our collaboration with a subsidiary of Roivant Sciences Ltd. is included below.

 

2


On November 3, 2020, we entered into a research collaboration and license agreement (the “Roivant Agreement”) with a newly formed affiliate of Roivant Sciences Ltd. (“Roivant” and such affiliate, “NewCo”) for the development and commercialization of certain product candidates that contain novel innate cell engager (“ICE”) molecules in oncology. Affimed has granted NewCo an exclusive, royalty-bearing, sublicensable worldwide license during the term of the Roivant Agreement under patent rights and know-how to develop and commercialize the product candidate and any additional product candidates against the exclusive targets designated by NewCo. Affimed will retain an option for co-promotion of the novel ICE® molecules.

The financial terms of the Roivant Agreement include upfront consideration to Affimed of $60 million, consisting of $40 million in cash and pre-paid research and development funding as well as $20 million in newly issued shares of Roivant, an affiliate of Roivant. Affimed is also eligible to receive up to approximately $2.0 billion in total milestone payments upon achievement of specified development, regulatory and commercial milestones pursuant to the Roivant Agreement. Of the $2.0 billion in milestone payments, approximately $219 million relate to development activities, $312 million relate to receipt of regulatory approvals, and $1.5 billion relate to achievement of specified thresholds of worldwide net sales. In addition, Affimed is eligible to receive tiered royalties from NewCo on net sales of licensed product candidates on a product-by-product and country-by-country basis until the later of (i) the date when the last valid patent covering the composition of matter or use of such licensed product in the applicable country expires; (ii) the tenth anniversary of the date of first commercial sale of such licensed product in such country or (iii) the expiration of regulatory data exclusivity for such product in such country.

Under the terms of the Roivant Agreement, NewCo will be primarily responsible for clinical development and commercialization worldwide in respect of each product candidate while Affimed will collaborate in the discovery and research phases of molecule development. Each product candidate will be developed pursuant to a research program (“Research Program”) and conducted by a joint project team, which will be overseen by a joint steering committee (the “JSC”), consisting of an equal number of representatives of NewCo and Affimed. If the JSC is unable to reach agreement on a particular matter, NewCo generally has final decision-making authority, provided that the JSC may not decide on matters that (i) relate exclusively to the use of Affimed’s innate cell engaging ROCK® technology platform as generally applied and not specifically applied to any licensed antibody products developed under their corresponding Research Program and directed, as applicable, to the lead target or any additional NewCo targets or (ii) would increase the then current number of full-time equivalents (“FTEs”) that Affimed has assigned to the performance of the research plan for a certain Research Program by more than a certain number of additional FTEs. Except with respect to the activities being conducted by NewCo and Affimed under the Research Programs and subject to Affimed’s co-promotion option, NewCo shall have sole responsibility for, and bear all costs for, researching, developing and commercializing each product candidate, including all regulatory matters in relation thereto. The Research Programs will be funded by NewCo through an upfront payment to Affimed.

The Company is subject to certain effort requirements in connection with its research activities under the Roivant Agreement, provision of technical assistance to NewCo and agreement with NewCo upon designation of the exclusive targets. NewCo must use diligent efforts to clinically develop and commercialize in one of the United States, European Union or Japan at least one licensed product that binds to each exclusive target.

NewCo will own intellectual property that solely relates to the composition, method of use or manufacture of the any antibody product directed against the designated targets. Affimed will own intellectual property that is an improvement of or otherwise solely relates to Affimed’s innate cell engaging ROCK® technology. Other newly developed intellectual property will either be owned solely by a party if that party solely developed it or will be jointly owned by Affimed and NewCo if developed by both parties.

The Roivant Agreement will expire on a country-by-country basis and licensed product-by-licensed product basis until there is no remaining royalty payment or other payment obligation in such country with respect to a licensed product. Either party may terminate the Roivant Agreement in its entirety, or with respect to a particular target, for any uncured material breach of the Roivant Agreement by the other party. Either party may also terminate the Roivant Agreement upon the other party’s insolvency.

NewCo also has the right to unilaterally terminate the Roivant Agreement in its entirety, in its sole discretion, upon certain advance written notice. If the Roivant Agreement is terminated in its entirety, either by NewCo for convenience or by Affimed for Newco’s uncured material breach or bankruptcy, Affimed has a right to negotiate commercially reasonable terms under which NewCo grants to Affimed a license to the licensed products with respect to any exclusive target existing as of such termination date. If Affimed does not agree with NewCo on such terms, the dispute will be settled by arbitration.

Research and Development Expense

We will use our existing liquidity primarily to fund research and development expense. Our research and development expense is highly dependent on the development phases of our research projects and therefore fluctuates highly from period to period. Our research and development expense mainly relates to the following key programs:

 

   

AFM13. In November 2019, we initiated a registration directed phase 2 study of AFM13 as monotherapy in relapsed or refractory patients suffering from peripheral T cell lymphoma (pTCL). The study protocol has been agreed upon with the U.S. Food and Drug Administration (FDA). The study design follows a 2 stage Simon design with a preplanned interim analysis after 40 patients. Enrollment in the study has reached the threshold for the interim analysis, and we now expect the

 

3


 

interim analysis will occur in the first half of 2021. In addition, this study will, as a separate cohort, investigate the initial efficacy of AFM13 as monotherapy in patients suffering from transformed mycosis fungoides (T-MF), though enrollment in this cohort has been paused pending the resolution of the COVID-19 pandemic. In September 2019, the FDA cleared an investigational new drug application (IND) for an investigator-sponsored Phase 1 study, in which the University of Texas MD Anderson Cancer Center (MDACC) is investigating the combination of AFM13 with allogeneic NK cells. In October 2020, we announced that MDACC has dosed the first patient in the study. MDACC is administering a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells in different doses (numbers of pre-loaded NK cells) into patients with relapsed/refractory CD30-positive lymphoid malignancies. In 2017, an investigator-sponsored Phase 1b/2a study was initiated by Columbia University to investigate AFM13 as monotherapy in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation; a poster presentation highlighting the final results from this study has been accepted at the American Society of Hematology (ASH) Annual Meeting and Exposition in December 2020. In 2016, we initiated a phase 1b study investigating the combination of AFM13 with Merck’s anti-PD1 antibody Keytruda® (pembrolizumab) in patients with relapsed/refractory HL. In this study, enrollment is complete and final data were presented at the International Conference on Malignant Lymphoma in June 2019. Different dosing protocols are being explored in the investigator-initiated monotherapeutic phase 2a clinical trial of AFM13 in relapsed/refractory Hodgkin Lymphoma, or relapsed/refractory HL, to allow for improved exposure in more heavily pretreated patient populations. The study has now completed recruitment and results will be presented at the ASH Annual Meeting and Exposition in December 2020. We anticipate that our research and development expenses in 2020 for AFM13 will increase compared to those for 2019 due to the initiation of new clinical studies, pre-clinical studies with collaboration partners and the preparation of the production of AFM13 for commercial purposes.

 

   

AFM11. In line with the strategic focus on our innate cell engager portfolio, we have made the decision to terminate the Phase 1 clinical program of AFM11. This decision took into consideration the competitive landscape of B-cell directed therapies currently in development and associated resources needed for further development of AFM11. We subsequently informed the FDA of our intention to terminate the clinical program.

 

   

AFM24. AFM24, a tetravalent, bispecific epidermal growth factor receptor, and CD16A-binding innate cell engager, is enrolling for a phase 1/2a clinical trial in patients with advanced cancers known to express EGFR. We anticipate that our research and development expenses in 2020 for AFM24 will increase compared to those for 2019 due to the beginning of the clinical trial of AFM24 in patients.

 

   

Other projects and infrastructure costs. Our other research and development expenses relate to our Genentech collaboration, to AFM32, which we have recently licensed to Roivant and will continue to develop under our collaboration with Roivant, and to an Affimed owned preclinical program (AFM28) and early stage development/discovery activities. We have allocated a material amount of our resources to such discovery activities. The expenses mainly consist of salaries, manufacturing costs for pre-clinical study material and pre-clinical studies. In addition, we incur a significant amount of costs associated with our research and development that are non-project specific, including intellectual property-related expenses, depreciation expenses and facility costs. Because these are less dependent on individual ongoing programs, they are not allocated to specific projects. We assume that other projects and infrastructure costs will increase in the remainder of 2020 due to increased early stage development/discovery activities.

Results of Operations

The financial information shown below was derived from our unaudited interim condensed consolidated financial statements for the three and nine month periods ended September 30, 2020 and 2019. The discussion below should be read along with these financial statements, and it is qualified in its entirety by reference to them.

Comparison of the three months ended September 30, 2020 and 2019

 

    

Three months

ended September 30,

 
     2020      2019  
     (unaudited)  
     (in € thousand)  

Total Revenue:

     10,545        2,103  

Other income (expenses)—net

     102        49  

Research and development expenses

     (10,101      (11,721

General and administrative expenses

     (3,455      (2,790

Operating loss

     (2,909      (12,359

Finance (costs)/income—net

     (3,057      1,475  

Loss before tax

     (5,966      (10,884

 

4


Income taxes

     0        0  

Loss for the period

     (5,966      (10,884

Other comprehensive (loss)

     (139      (555

Total comprehensive loss

     (6,105      (11,439

Loss per common share in € per share (undiluted)

     (0.07      (0.17

Loss per common share in € per share (diluted)

     (0.07      (0.17

Revenue

Revenue increased significantly to €10.5 million in the three months ended September 30, 2020 from €2.1 million for the three months ended September 30, 2019. Revenue in the three months ended September 30, 2020 predominantly relates to the Genentech collaboration (€10.5 million, 2019: €1.9 million). Revenue from the Genentech collaboration in the three months ended September 30, 2020 was recognized for collaborative research services performed during the quarter and the achievement of a clinical milestone.

Research and development expenses

 

     Three months ended
September 30,
 
R&D Expenses by Project    2020      2019      Change %  
     (unaudited)         
     (in € thousand)         

Project

        

AFM13

     2,742        6,023        (54 %) 

AFM11

     (3      (86      (97 %) 

AFM24

     2,156        864        150

Other projects and infrastructure costs

     4,808        4,603        4

Share-based payment expense

     398        317        26

Total

     10,101        11,721        (14 %) 

Research and development expenses amounted to €10.1 million in the three months ended September 30, 2020 compared to research and development expenses of €11.7 million in the three months ended September 30, 2019. The variances in project-related expenses between the three months ended September 30, 2020 and the corresponding period in 2019 are mainly due to the following projects:

 

   

AFM13. In the three months ended September 30, 2020, we incurred lower expenses (54%) than in the three months ended September 30, 2019 primarily due to lower expenses for manufacturing activities for clinical trial material.

 

   

AFM11. In the three months ended September 30, 2020 and 2019, we recognized refunds from service providers following the termination of clinical trials.

 

   

AFM24. In the three months ended September 30, 2020, expenses were significantly higher (150%) and related to the initiation of the phase 1/2a clinical trial and manufacturing activities for the clinical trial material.

 

   

Other projects and infrastructure costs. In the three months ended September 30, 2020, expenses were slightly higher (4%) than in the three months ended September 30, 2019. Expenses related to our discovery/early stage development activities and infrastructure costs.

 

5


General and administrative expenses

General and administrative expenses were higher and amounted to €3.5 million in the three months ended September 30, 2020 compared to €2.8 million in the three months ended September 30, 2019. The increase is mainly due to higher personnel expenses and legal, consulting and audit costs.    

Finance income / (costs)-net

Finance costs for the three months ended September 30, 2020 totaled €3.1 million, compared to €1.5 million income for the three months ended September 30, 2019. Finance costs and finance income in the three months ended September 30, 2020 and 2019 primarily include foreign exchange losses and gains.

Comparison of the nine months ended September 30, 2020 and 2019

 

    

Nine months

ended September 30,

 
     2020      2019  
     (unaudited)  
     (in € thousand)  

Total Revenue:

     18,614        17,464  

Other income/(expenses)—net

     130        332  

Research and development expenses

     (33,247      (31,253

General and administrative expenses

     (9,586      (7,566

Operating loss

     (24,089      (21,023

Finance income/(costs)—net

     (2,404      1,655  

Loss before tax

     (26,493      (19,368

Income taxes

     0        (4

Loss for the period

     (26,493      (19,372

Other comprehensive loss

     (129      (531

Total comprehensive loss

     (26,622      (19,903

Loss per common share in € per share (undiluted)

     (0.33      (0.31

Loss per common share in € per share (diluted)

     (0.33      (0.31

Revenue

Revenue increased from €17.5 million in the nine months ended September 30, 2019 to €18.6 million for the nine months ended September 30, 2020. Revenue in the nine months ended September 30, 2020 predominantly relate to the Genentech collaboration (€18.1 million, 2019: €16.2 million). Revenue from the Genentech collaboration in the nine months ended September 30, 2020 was recognized for collaborative research services performed during the first three quarters of the year and the achievement of a clinical milestone, while revenue in the nine months ended September 30, 2019 was recognized for collaborative research services and the achievement of a preclinical milestone.

Research and development expenses

 

     Nine months ended
September 30,
        
R&D Expenses by Project    2020      2019      Change %  
     (unaudited)         
     (in € thousand)         

Project

        

AFM13

     13,928        12,631        10

AFM11

     (80      1,909        —    

AFM24

     4,670        2,950        58

Other projects and infrastructure costs

     13,614        12,946        5

Share-based payment expense

     1,115        817        36

Total

     33,247        31,253        6

 

6


Research and development expenses increased from €31.3 million in the nine months ended September 30, 2019 to €33.2 million in the nine months ended September 30, 2020. The variances in project-related expenses between the nine months ended September 30, 2020 and the corresponding period in 2019 are mainly due to the following projects:

 

   

AFM13. In the nine months ended September 30, 2020, we incurred higher expenses (10%) than in the nine months ended September 30, 2019 primarily due to higher expenses for the preparation of new clinical trials and manufacturing activities for clinical trial material.

 

   

AFM11. In the nine months ended September 30, 2020, we recognized refunds from service providers following the termination of clinical trials. The majority of the expenses in the nine months ended September 30, 2019 are related to costs for the termination of the phase 1 clinical program of AFM11.

 

   

AFM24. In the nine months ended September 30, 2020, we incurred higher expenses due to the initiation of the phase 1/2a clinical trial and manufacturing activities for the clinical trial material.

 

   

Other projects and infrastructure costs. In the nine months ended September 30, 2020, expenses were slightly higher compared to the previous year and related to our earlier stage programs and discovery/early stage development activities and infrastructure costs.

General and administrative expenses

General and administrative expenses for the nine months ended September 30, 2020 were €9.6 million, compared with €7.6 million for the nine months ended September 30, 2019. The increase is mainly due to higher personnel expenses, higher compliance costs with the Sarbanes-Oxley Act of 2002, and legal, consulting and audit costs.

Finance income / (costs)-net

Finance costs for the nine months ended September 30, 2020 were €2.4 million, compared with finance income of €1.7 million for the nine months ended September 30, 2019. Finance costs in the nine months ended September 30, 2020 is primarily related to foreign exchange losses.

 

7


Liquidity and Capital Resources

Since inception, we have incurred significant operating losses. To date, we have not generated any product sale revenue. We have financed our operations primarily through our public offerings of our common shares, private placements of equity securities and loans, grants and payments from collaboration partners.

Cash flows

The table below summarizes our consolidated statement of cash flows for the nine months ended September 30, 2020 and 2019:

 

     Nine months ended
September 30,
 
     2020      2019  
     (unaudited)  
     (in € thousand)  

Net cash used in operating activities

     (35,130      (30,613

Net cash generated/(used) in investing activities

     627        (2,532

Net cash provided/(used) by financing activities

     31,175        (2,050

Exchange rate related changes of cash and cash equivalents

     (2,250      361  

Net changes to cash and cash equivalents

     (3,328      (35,195

Cash and cash equivalents at the beginning of the period

     95,234        94,829  

Cash and cash equivalents at the end of the period

     89,656        59,995  

Net cash used in operating activities of €35.1 million in the nine months ended September 30, 2020 is higher than net cash used in operating activities in the nine months ended September 30, 2019 (€30.6 million) primarily due to higher operating expenses. The investing activities in the nine months ended September 30, 2020 and 2019 primarily relate to investments in and proceeds from the sale or maturity of financial assets. Net cash provided by financing activities in the nine months ended September 30, 2020 relate primarily to the issuance of shares in connection with our ATM program. Net cash used in financing activities in the nine months ended September 30, 2019 relate primarily to the repayment of borrowings.

Cash and Funding Sources

Our cash and cash equivalents and financial assets as of September 30, 2020 were €97.3 million, compared with €104.1 million as of December 31, 2019. Funding sources generally comprise proceeds from the issuance of equity instruments, payments from collaboration partners, loans and government grants.

Funding Requirements

We expect that we will require additional funding to complete the development of our product candidates and to continue to advance the development of our other product candidates. If we receive regulatory approval for AFM13, AFM24 or other earlier programs, and if we choose not to grant any licenses to partners, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We also continue to incur substantial costs associated with operating as a public company. Additional funds may not be available on a timely basis, on favorable terms, or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy. If we are not able to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.

Based on our current operating and budget assumptions including the proceeds to be received from the collaborations with Genentech and Roivant, we believe that our existing liquidity, will enable us to fund our operating expenses and capital expenditure requirements into the first half of 2023. We have based this estimate on assumptions that may prove to be incorrect, and we could use our capital resources sooner than we currently expect. Our future funding requirements will depend on many factors, including but not limited to:

 

   

the scope, rate of progress, results and cost of our clinical trials, nonclinical testing, and other related activities;

 

8


   

the cost of manufacturing clinical supplies, and establishing commercial supplies, of our product candidates and any products that we may develop;

 

   

the number and characteristics of product candidates that we pursue;

 

   

the cost, timing, and outcomes of regulatory approvals;

 

   

the cost and timing of establishing sales, marketing, and distribution capabilities; and

 

   

the terms and timing of any collaboration, licensing, and other arrangements that we may establish, including any required milestone and royalty payments thereunder.

To address our financing needs, we may raise additional capital through the sale of equity or convertible debt securities. In such an event, the ownership interest of our shareholders will be diluted, and the terms of any such securities may include liquidation or other preferences that adversely affect the rights of holders of our common shares.

For more information as to the risks associated with our future funding needs, see “Risk Factors” in the Annual Report.

Contractual Obligations and Commitments

As of the date of this discussion and analysis there are no material changes to our contractual obligations from those reported in “Item 5. Operating and Financial Review and Prospects—F. Tabular disclosure of contractual obligations” in the Annual Report.

Off-balance Sheet Arrangements

As of the date of this discussion and analysis, we do not have any, and during the periods presented we did not have any, off-balance sheet arrangements other than operating leases as described under “Item 5. Operating and Financial Review and Prospects—F. Tabular disclosure of contractual obligations” in the Annual Report.

Quantitative and Qualitative Disclosures About Market Risk

During the nine months ended September 30, 2020 there were no significant changes to our quantitative and qualitative disclosures about market risk from those reported in “Item 11. Quantitative and Qualitative Disclosures About Risk” in the Annual Report.

Critical Judgments and Accounting Estimates

There have been no material changes to the significant accounting policies and estimates described in “Item 5. Operating and Financial Review and Prospects—A. Operating Results Overview—Critical Judgments and Accounting Estimates” in the Annual Report.

Recent Accounting Pronouncements

We refer to note 2 of the notes to the unaudited interim condensed consolidated financial statements for the three and nine month periods ended September 30, 2020 and 2019 with regard to the impact of recent accounting pronouncements.

Cautionary Statement Regarding Forward Looking Statements

Forward-looking statements appear in a number of places in this discussion and analysis and include, but are not limited to, statements regarding our intent, belief or current expectations. Many of the forward-looking statements contained in this discussion and analysis can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate” and “potential,” among others. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to of various factors, including, but not limited to, those identified under the section entitled “Risk Factors” in the Annual Report. These risks and uncertainties include factors relating to:

 

   

our operation as a development stage company with a history of operating losses; as of September 30, 2020, our accumulated deficit was €261.0 million;

 

9


   

the chance our clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trials;

 

   

our reliance on contract manufacturers and contract research organizations over which we have limited control;

 

   

our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates;

 

   

our dependence on the success of AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not exploitable;

 

   

uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized;

 

   

the outcome of any, or any discussions we may enter regarding, acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings;

 

   

the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or in the commercial stage;

 

   

if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory overview;

 

   

enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization;

 

   

future legislation may materially impact our ability to realize revenue from any approved and commercialized products;

 

   

the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues;

 

   

our reliance on our current strategic relationships with LLS, NK Max America, Roivant, Artiva, The MD Anderson Cancer Center, Genentech, Amphivena and the potential failure to enter into new strategic relationships;

 

   

our reliance on third parties to conduct our nonclinical and clinical trials and on third-party single-source suppliers to supply or produce our product candidates;

 

   

our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization;

 

   

our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel;

 

   

the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; and

 

   

other risk factors discussed under “Item 3. Key Information—D. Risk Factors” in the Annual Report.

Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do so, what impact they will have on our results of operations, cash flows or financial condition. Additionally, some of the risks and uncertainties identified above may be amplified by the recent COVID-19 outbreak. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknown. Except as required by law, we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

 

10

EX-99.3

Exhibit 99.3

 

LOGO

PRESS RELEASE

Affimed Reports Third Quarter 2020 Financial Results and

Highlights Recent Operational Progress

 

 

Established license and strategic collaboration with Roivant Sciences - $60 million in upfront consideration and up to $2 billion in future milestones

 

 

Recognized milestone payment from Genentech for initiation of Phase 1 of RO7297089

 

 

Ended quarter with €97.3 million of cash, cash equivalents and current financial assets with anticipated cash runway into first half of 2023

 

 

AFM13 pTCL REDIRECT monotherapy study – interim analysis expected during first half of 2021

 

 

AFM24 (Phase 1/2a) completed cohort 2 and is enrolling and treating patients in cohort 3

 

 

First patient dosed with preloaded AFM13 allogeneic cord blood-derived natural killer cells at MD Anderson Cancer Center

 

 

Collaborations formed with NKMax America and Artiva Biotherapeutics to accelerate innate cell engager (ICE®) / NK cell therapy combinations

 

 

Data from one preclinical and two clinical studies to be presented at upcoming SITC and ASH scientific conferences

 

 

Conference call and webcast scheduled for November 10, 2020 at 8:30 am EST

Heidelberg, Germany, November 10, 2020 – 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 three and nine months ended September 30, 2020 and provided an update on clinical and corporate progress.

“We have made significant progress with regards to executing our strategy by advancing the development of our innate cell engagers as monotherapy and in combinations. The partnership with Roivant Sciences broadens our pipeline and advances AFM32 towards clinical development; proceeds from the deal extend our cash runway into 2023,” said Dr. Adi Hoess, CEO of Affimed. “In addition, we have secured important new NK cell collaborations that broaden the development of our lead therapeutic candidates. As we move ahead, we look forward to reporting on progress of the different programs and generating additional data.”

 

1


Clinical Stage Program Updates

AFM13 (CD30/CD16A)

 

 

AFM13-202, a Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with CD30-positive peripheral T-cell lymphoma (pTCL), has recruited the prespecified number of patients for the preplanned interim analysis. Affimed now expects to complete the interim data analysis during the first half of 2021.

 

 

AFM13-104, an investigator sponsored Phase 1 study at MD Anderson Cancer Center evaluating the tolerability and efficacy of AFM13 preloaded cord blood-derived NK (cbNK) cells followed by weekly AFM13 monotherapy in patients with refractory CD30 expressing lymphomas, reported that the first patient has completed the first four-week cycle without noteworthy toxicity and has achieved a partial response according to investigator assessment. The patient is intended to receive a second treatment cycle.

 

 

An oral presentation of the preclinical data from the collaborations with MD Anderson Cancer Center and the University of Washington combining allogeneic cbNK cells preloaded with AFM13 will be presented at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) on November 11th.

 

 

Two abstracts on studies with AFM13 have been accepted for poster presentation at the 62nd American Society of Hematology Annual Meeting and Exposition (ASH). The data presented will be from Columbia University’s AFM13 study in patients with relapsed or refractory CD30-positive lymphoma with cutaneous presentation and data from the German Hodgkin Study Group study in patients with relapsed or refractory Hodgkin Lymphoma.

AFM24 (EGFR/CD16A)

 

 

AFM24-101, a Phase 1/2a clinical trial of AFM24, the EGFR/CD16A targeted ICE® for patients with EGFR-expressing solid tumors, completed dose cohort 2 and patients are currently being enrolled and treated in cohort 3.

 

 

Affimed entered a clinical collaboration to investigate the combination of AFM24 with NKMax America’s autologous NK cell therapy, SNK01, in a first-in-human proof of concept (POC) trial in patients with EGFR-expressing tumors. The agreement includes an option to broaden the collaboration to include NKMax America’s allogeneic NK cell product. The agreement follows a preclinical collaboration between the two companies that showed synergy between Affimed’s ICE® molecules and NKMax America’s autologous and cryopreserved allogeneic NK cell products.

 

2


Roivant Sciences Partnership

 

 

Affimed entered into a licensing and strategic collaboration agreement with Roivant Sciences under which the Company will receive $60 million in upfront consideration, including $40 million in cash and pre-funded R&D and $20 million of Roivant equity, up to an additional $2 billion in future milestones and tiered royalties.

 

 

Affimed will grant a license to AFM32 with options for additional ICE® molecules directed against targets not included in Affimed’s current pipeline.

 

 

Affimed to be responsible for all preclinical work through IND-filing.

 

 

Roivant Sciences to form new subsidiary focused on the development and commercialization of ICE®-based therapeutics.

 

 

Affimed retains certain co-promotional rights.

Genentech Partnership

 

 

The Genentech-partnered, novel BCMA-targeted innate cell engager for the treatment of multiple myeloma is treating patients in a first-in-human Phase I, open-label, multicenter, global dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of RO7297089.

 

 

The initiation of the Phase 1 study triggered a milestone payment recognized in the third quarter.

Preclinical Pipeline Update

 

 

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

 

 

Affimed entered a R&D collaboration with Artiva Biotherapeutics to develop off-the-shelf, cryopreserved, co-vialed allogeneic natural killer (NK) cell therapeutics pre-loaded with its ICE® compounds.

Third Quarter 2020 Financial Highlights

(Figures for the third quarter ended September 30, 2020 and 2019 are unaudited.)

As of September 30, 2020, cash, cash equivalents and current financial assets totaled €97.3 million compared to €104.1 million on December 31, 2019. The pro forma cash position of the company as of September 30, 2020, including the $40 million of upfront cash proceeds from the Roivant collaboration, would be €131.5 million. During the quarter, the company received net proceeds of approximately €11.6 million under its at-the-market (“ATM”) program and a milestone payment from its partnership with Genentech in an undisclosed amount.

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

 

3


Net cash used in operating activities for the quarter ended September 30, 2020 was €3.6 million compared to €11.7 million in the third quarter of 2019.

Total revenue for the third quarter of 2020 was €10.5 million compared with €2.1 million in the third quarter of 2019. Revenue for the third quarter of 2020 and 2019 predominantly relate to the Genentech collaboration (2020: €10.5 million, 2019: €1.9 million). Revenue from the Genentech collaboration in the third quarter 2020 was comprised of revenue recognized for collaborative research services performed during the quarter and the recognition of revenue related to a milestone payment.

R&D expenses for the third quarter of 2020 were €10.1 million compared to €11.7 million in the third quarter of 2019. Expenses in 2020 relate predominantly to our AFM13 and AFM24 clinical programs as well as to our early stage development and discovery activities.

G&A expenses for the third quarter of 2020 were €3.5 million compared to €2.8 million in the third quarter of 2019.

Net loss for the third quarter of 2020 was €6.0 million or €0.07 per common share. For the third quarter of 2019, the company’s net loss was €10.9 million or €0.17 per common share.

The weighted number of common shares outstanding for the quarter ended September 30, 2020 were 86.0 million.

Affimed encourages shareholders to also review its 6-K filing for the quarter ended September 30, 2020, as filed with the United States Securities and Exchange Commission.

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 today, Tuesday, November 10, 2020 at 8:30 a.m. EST to discuss third 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 9847055 approximately 15 minutes prior to the call.

 

4


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. Affimed’s fit-for-purpose ROCK® platform allows innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and into a Phase 1/2a dose escalation/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. 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 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 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.

 

5


Investor Relations Contact

Alexander Fudukidis

Head of Investor Relations

E-Mail: a.fudukidis@affimed.com

Tel.: (917) 436-8102

 

6


Affimed N.V.

Unaudited consolidated statements of comprehensive income / (loss) (in € thousand)

 

    

For the three months

ended September 30

   

For the nine months

ended September 30

 
     2020     2019     2020     2019  

Revenue

     10,545       2,103       18,614       17,464  

Other income – net

     102       49       130       332  

Research and development expenses

     (10,101     (11,721     (33,247     (31,253

General and administrative expenses

     (3,455     (2,790     (9,586     (7,566
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating income / (loss)

     (2,909     (12,359     (24,089     (21,023

Finance income / (costs) – net

     (3,057     1,475       (2,404     1,655  
  

 

 

   

 

 

   

 

 

   

 

 

 

Income / (loss) before tax

     (5,966     (10,884     (26,493     (19,368

Income taxes

     0       0       0       (4
  

 

 

   

 

 

   

 

 

   

 

 

 

Income / (loss) for the period

     (5,966     (10,884     (26,493     (19,372
  

 

 

   

 

 

   

 

 

   

 

 

 

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

     (139     (555     (129     (531
  

 

 

   

 

 

   

 

 

   

 

 

 

Other comprehensive income / (loss)

     (139     (555     (129     (531
  

 

 

   

 

 

   

 

 

   

 

 

 

Total comprehensive income / (loss)

     (6,105     (11,439     (26,622     (19,903
  

 

 

   

 

 

   

 

 

   

 

 

 

Earnings / (loss) per share in € per share

     (0.07     (0.17     (0.33     (0.31

(undiluted = diluted)

    

Weighted number of common shares outstanding

     86,030,878       62,443,550       80,490,155       62,437,673  

 

7


Affimed N.V.

Consolidated statements of financial position (in € thousand)

 

     September 30,
2020
    December 31,
2019
 
     (unaudited)        

ASSETS

    

Non-current assets

    

Intangible assets

     93       137  

Leasehold improvements and equipment

     2,305       2,291  

Long term financial assets

     3,064       3,193  

Right-of-use assets

     1,084       824  
  

 

 

   

 

 

 
     6,546       6,445  

Current assets

    

Cash and cash equivalents

     89,656       95,234  

Financial assets

     7,687       8,902  

Trade and other receivables

     2,552       1,482  

Inventories

     410       296  

Other assets

     1,087       0  
  

 

 

   

 

 

 
     101,392       105,914  

TOTAL ASSETS

     107,938       112,359  

EQUITY AND LIABILITIES

    

Equity

    

Issued capital

     883       762  

Capital reserves

     305,301       270,451  

Fair value reserves

     1,833       1,962  

Accumulated deficit

     (261,001     (234,508
  

 

 

   

 

 

 

Total equity

     47,016       38,667  

Non-current liabilities

    

Borrowings

     207       278  

Contract liabilities

     15,203       37,961  

Lease liabilities

     332       272  
  

 

 

   

 

 

 

Total non-current liabilities

     15,742       38,511  

Current liabilities

    

Trade and other payables

     8,123       10,674  

Provisions

     479       517  

Borrowings

     1,070       2,105  

Lease liabilities

     779       532  

Contract liabilities

     34,729       21,353  
  

 

 

   

 

 

 

Total current liabilities

     45,180       35,181  

TOTAL EQUITY AND LIABILITIES

     107,938       112,359  

 

8


Affimed N.V.

Unaudited consolidated statements of cash flows (in € thousand)

 

(in € thousand)    For the nine months
ended September 30
 
     2020     2019  

Cash flow from operating activities

    

Income / (loss) for the period

     (26,493     (19,372

Adjustments for the period:

    

- Income taxes

     0       4  

- Depreciation and amortization

     821       648  

- Net gain from disposal of leasehold improvements and equipment

     0       (9

- Share based payments

     2,348       1,981  

- Finance income / (costs) – net

     2,404       (1,655
  

 

 

   

 

 

 
     (20,920     (18,403

Change in trade and other receivables

     (1,174     458  

Change in inventories

     (114     (70

Change in other assets

     (1,087     (1,104

Change in trade, other payables, provisions and contract liabilities

     (12,053     (11,727
  

 

 

   

 

 

 

Cash used in operating activities

     (35,348     (30,846

Interest received

     299       413  

Paid interest

     (81     (180
  

 

 

   

 

 

 

Net cash used in operating activities

     (35,130     (30,613

Cash flow from investing activities

    

Purchase of intangible assets

     (8     (143

Purchase of leasehold improvements and equipment

     (352     (926

Cash paid for investments in financial assets

     (8,101     (39,733

Cash received from maturity of financial assets

     9,088       38,270  
  

 

 

   

 

 

 

Net cash used for investing activities

     627       (2,532

Cash flow from financing activities

    

Proceeds from issue of common shares

     33,846       26  

Transaction costs related to issue of common shares

     (1,134     0  

Proceeds from borrowings

     0       562  

Repayment of lease liabilities

     (386     (299

Repayment of borrowings

     (1,151     (2,339
  

 

 

   

 

 

 

Cash flow from financing activities

     31,175       (2,050

Exchange-rate related changes of cash and cash equivalents

     (2,250     361  

Net changes to cash and cash equivalents

     (3,328     (35,195

Cash and cash equivalents at the beginning of the period

     95,234       94,829  
  

 

 

   

 

 

 

Cash and cash equivalents at the end of the period

     89,656       59,995  
  

 

 

   

 

 

 

 

9


Affimed N.V.

Unaudited 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  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Exercise of share based payment awards

        26            26  

Equity-settled share based payment awards

        1,981            1,981  

Loss for the period

             (19,372     (19,372

Other comprehensive income

           (531       (531
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance as of September 30, 2019

     624        241,062        2,063       (221,516     22,233  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance as of January 1, 2020

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

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Issue of common shares

     121        32,502            32,623  

Equity-settled share based payment awards

        2,348            2,348  

Loss for the period

             (26,493     (26,493

Other comprehensive income

           (129       (129
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

Balance as of September 30, 2020

     883        305,301        1,833       (261,001     47,016  
  

 

 

    

 

 

    

 

 

   

 

 

   

 

 

 

 

10