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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 August, 2023

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 333-251658), Form F-3 (Registration Number 333-260946), Form S-8 (Registration Number 333-198812) and Form S-8 (Registration Number 333-270798) of Affimed N.V. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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.

AFFIMED N.V.

Date:

August 10, 2023

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 June 30, 2023.

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 August 10, 2023.

101.INS

XBRL Instance Document.

101.SCH

XBRL Taxonomy Extension Schema Document.

101.CAL

XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF

XBRL Taxonomy Extension Definition Linkbase Document.

101.IAB

XBRL Taxonomy Extension Labels Linkbase Document.

101.PRE

XBRL Taxonomy Extension Presentation Linkbase Document.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

0.0033P30D

Exhibit 99.1

Affimed N.V.

Unaudited consolidated interim statements of comprehensive loss

(in € thousand)

For the three months ended

For the six months ended

June 30

June 30

    

Note

    

2023

    

2022

    

2023

    

2022

Revenue

3

1,390

7,301

5,900

15,307

Other income – net

 

 

717

 

240

 

1,127

 

524

Research and development expenses

 

 

(25,273)

 

(20,829)

 

(54,804)

 

(39,208)

General and administrative expenses

 

 

(6,276)

 

(8,374)

 

(13,126)

 

(15,419)

Operating loss

 

4

 

(29,442)

 

(21,662)

 

(60,903)

 

(38,796)

Finance income / (costs) – net

 

5

 

47

 

2,253

 

(472)

 

2,724

Loss before tax

 

 

(29,395)

 

(19,409)

 

(61,375)

 

(36,072)

Income taxes

 

 

0

 

0

 

(3)

 

(2)

Loss for the period

 

 

(29,395)

 

(19,409)

 

(61,378)

 

(36,074)

Other comprehensive loss

 

 

  

 

  

 

  

 

  

Items that will not be reclassified to profit or loss

 

 

  

 

  

 

  

 

  

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

 

6

 

0

 

(599)

 

0

 

(6,773)

Other comprehensive loss

 

 

0

 

(599)

 

0

 

(6,773)

Total comprehensive loss

 

 

(29,395)

 

(20,008)

 

(61,378)

 

(42,847)

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

 

 

(0.20)

 

(0.13)

 

(0.41)

 

(0.27)

Weighted number of common shares outstanding

 

 

149,339,335

 

147,326,291

 

149,339,335

 

135,385,254

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

1

Affimed N.V.

Consolidated interim statements of financial position

(in € thousand)

    

    

June 30, 

    

December 31, 

Note

2023

2022

(unaudited)

ASSETS

 

 

  

 

  

Non-current assets

 

 

  

 

  

Intangible assets

 

 

46

 

58

Leasehold improvements and equipment

 

 

3,518

 

3,823

Right-of-use assets

 

 

311

 

561

 

3,875

 

4,442

Current assets

 

 

  

 

  

Cash and cash equivalents

 

 

120,056

 

190,286

Trade and other receivables

 

7

 

2,154

 

2,697

Inventories

 

 

694

 

628

Other assets and prepaid expenses

 

8

 

7,932

 

2,459

 

130,836

 

196,070

TOTAL ASSETS

 

 

134,711

 

200,512

EQUITY AND LIABILITIES

 

 

  

 

  

Equity

 

 

  

 

  

Issued capital

 

 

1,493

 

1,493

Capital reserves

 

 

590,232

 

582,843

Fair value reserves

 

 

(1,231)

 

(1,231)

Accumulated deficit

 

 

(491,568)

 

(430,190)

Total equity

 

9

 

98,926

 

152,915

Non current liabilities

 

 

  

 

  

Borrowings

 

11

 

9,000

 

11,687

Contract liabilities

 

3

 

774

 

1,083

Lease liabilities

 

 

123

 

176

Total non-current liabilities

 

 

9,897

 

12,946

Current liabilities

 

 

  

 

  

Trade and other payables

 

 

15,810

 

19,077

Borrowings

 

11

 

5,923

 

5,930

Lease liabilities

 

 

200

 

396

Contract liabilities

 

3

 

3,955

 

9,248

Total current liabilities

 

 

25,888

 

34,651

TOTAL EQUITY AND LIABILITIES

 

 

134,711

 

200,512

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

2

Affimed N.V.

Unaudited consolidated interim statements of cash flows

(in € thousand)

For the six months ended

June 30

    

Note

    

2023

    

2022

Cash flow from operating activities

  

  

Loss for the period

 

 

(61,378)

 

(36,074)

Adjustments for the period:

 

 

  

 

  

- Income taxes

 

 

3

 

2

- Depreciation and amortization

 

 

577

 

703

- Share-based payments

 

10

 

7,389

 

9,872

- Finance income / (costs) – net

 

5

 

472

 

(2,724)

 

(52,937)

 

(28,221)

Change in trade and other receivables

 

 

543

 

(715)

Change in inventories

 

 

(66)

 

(150)

Change in other assets and prepaid expenses

 

 

(5,473)

 

(3,873)

Change in trade, other payables, provisions and contract liabilities

 

 

(8,867)

 

(21,372)

(66,800)

(54,331)

Interest received

 

 

924

 

82

Paid interest

 

 

(695)

 

(653)

Paid income tax

(3)

(2)

Net cash used in operating activities

 

 

(66,574)

 

(54,904)

Cash flow from investing activities

 

 

  

 

  

Purchase of leasehold improvements and equipment

 

 

(11)

 

(194)

Cash received from the sale of financial assets

 

 

0

 

1,518

Net cash used for investing activities

 

 

(11)

 

1,324

Cash flow from financing activities

 

 

  

 

  

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

 

 

0

 

95,907

Transaction costs related to issue of common shares

 

 

0

 

(5,894)

Repayment of lease liabilities

 

 

(249)

 

(352)

Repayment of borrowings

 

11

 

(2,965)

 

(47)

Net cash used for financing activities

 

 

(3,214)

 

89,614

Exchange rate related changes of cash and cash equivalents

 

 

(431)

 

3,568

Net changes to cash and cash equivalents

 

 

(69,799)

 

36,034

Cash and cash equivalents at the beginning of the period

 

 

190,286

 

197,630

Cash and cash equivalents at the end of the period

 

 

120,056

 

237,232

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

3

Affimed N.V.

Unaudited consolidated interim statements of changes in equity

(in € thousand)

    

    

Issued

    

Capital

    

Fair Value

    

Accumulated

    

Total

Note

capital

reserves

reserves

deficit

equity

Balance as of January 1, 2022

 

 

1,234

 

474,087

 

(5,973)

 

(333,397)

 

135,951

Issue of common shares

 

 

259

 

89,484

 

  

 

  

 

89,743

Exercise of share-based payment awards

 

 

101

 

  

 

  

 

101

Equity-settled share-based payment awards

9,872

9,872

Transfer of cumulative loss on sale of financial assets

  

 

2,819

(2,819)

0

Loss for the period

 

 

 

 

(36,074)

 

(36,074)

Other comprehensive loss

 

 

  

 

  

 

(6,773)

 

  

 

(6,773)

Balance as of June 30, 2022

 

 

1,493

 

573,544

 

(9,927)

 

(372,290)

 

192,820

Balance as of January 1, 2023

 

 

1,493

 

582,843

 

(1,231)

 

(430,190)

 

152,915

Equity-settled share-based payment awards

 

10

 

  

 

7,389

 

  

 

  

 

7,389

Loss for the period

(61,378)

(61,378)

Balance as of June 30, 2023

 

 

1,493

 

590,232

 

(1,231)

 

(491,568)

 

98,926

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

4

1.     Reporting entity

Affimed N.V. is a Dutch company with limited liability (naamloze vennootschap) and has its corporate seat in Amsterdam, the Netherlands, registered with the trade register of the Chamber of Commerce (handelsregister van de Kamer van Koophandel) under number 60673389.

The condensed consolidated interim 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, and Affimed Inc., Delaware, USA (collectively “Affimed”, the “Company” or the “Group”).

Affimed is a clinical-stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies. The Group’s product candidates are developed in the field of immuno-oncology, which represents 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, where the Group is performing research services for third parties.

2.     Basis of preparation and changes to Group’s accounting policies

Statement of compliance

The condensed consolidated interim financial statements (referred to as the “interim financial statements”) as of June 30, 2023 and December 31, 2022 and for the three and six months ended June 30, 2023 and 2022 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 consolidated annual financial statements and should be read in conjunction with Affimed N.V.’s annual consolidated financial statements as of December 31, 2022.

The interim financial statements were authorized for issuance by the Company’s Management Board on August 10, 2023.

Loss per share

Loss per common share is calculated by dividing the loss for the period by the weighted average number of common shares outstanding during the period.  

As of June 30, 2023, the Group has granted 25,885,194 options and warrants in connection with share-based payment programs (see note 10) and a loan agreement, which could potentially have a dilutive effect but were excluded from the diluted weighted average number of ordinary shares calculation because their effect would have been anti-dilutive due to the net loss generated by the Group.

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 Group’s accounting policies were the same as those that applied to the consolidated financial statements as of and for the year ended December 31, 2022.

Functional and presentation currency

These interim financial statements are presented in euro. The functional currency of the Group’s subsidiaries is also the euro. 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 Group in these interim financial statements are the same as those applied by the Group in its consolidated financial statements as of and for the year ended December 31, 2022.

5

New standards and amendments to standards

The following forthcoming standards and amendments to standards have not been applied  in preparing these interim financial statements.

Standard/interpretation

    

Effective Date1

Amendments to IAS 1 Presentation of Financial Statements:

Classification of Liabilities as Current or Non-current

January 1, 2024

Amendments to IAS 1 Presentation of Financial Statements:

Non-current Liabilities with Covenants

January 1, 2024

Amendments to IFRS 16 Leases:

Lease Liability in a Sale and Leaseback

January 1, 2024

Amendments to IAS 7 Statement of Cash Flows and IFRS 7 Financial Instruments:

Disclosures: Supplier Finance Arrangements

January 1, 2024

The amended standards are not expected to have a significant effect on the interim financial statements of the Group.

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; and
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.

The carrying amount of all trade and other receivables, other assets and prepaid expenses, cash and cash equivalents, trade and other payables and loans 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 preferred and common shares in other companies held by the group is based on level 1 and 3 inputs (see note 5). The Group recognizes transfers between levels of the fair value hierarchy as the date at which the change has occurred.

1 Shall apply for periods beginning on or after the date shown in the effective date column.

6

3.     Revenue

Collaboration with Genentech Inc.

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

The Group recognized 0.2 million and 0.3 million as revenue during the three and six months ended June 30, 2023 (2022: 3.3 million and 7.3 million). As of the end of 2022, Affimed had completed work on and/or handed over all product candidates for further investigation by Genentech. The remaining revenue recognized during the six months ended June 30, 2023 relates to a platform license. As of June 30, 2023, the Group held contract liabilities of 1.4 million (December 31, 2022: 1.7 million), which 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.

Collaboration with Roivant Sciences Ltd.

On November 9, 2020, Affimed and Affivant Sciences GmbH (formerly Pharmavant 6 GmbH), a subsidiary of Roivant Sciences Ltd. (Roivant), announced a strategic collaboration agreement which grants Roivant a license to the preclinical molecule AFM32. Under the terms of the agreement, Affimed received $60 million in upfront consideration, comprised of $40 million in cash and pre-funded research and development funding, and $20 million of common shares in Roivant. The Group is eligible to receive up to an additional $2 billion in milestone payments upon achievement of specified development, regulatory and commercial milestones, as well as tiered royalties on net sales.

The Group recognized 1.1 million and 5.4 million as revenue during the three and six months ended June 30, 2023 (2022: 4.0 million and 7.9 million). As of June 30, 2023, the Group held contract liabilities of 3.3 million (December 31, 2022: 8.6 million), which will be recognized as revenue in subsequent periods as services are provided.

Contract balances

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

    

June 30, 2023

    

December 31, 2022

Receivables

 

10

 

0

Contract liabilities

 

4,729

 

10,331

An amount of  1.2 million and 5.7 million included in contract liabilities at the beginning of the period has been recognized as revenue during the three and six months ended June 30, 2023.

7

The remaining performance obligations as of June 30, 2023 are approximately 4.7 million and are expected to be largely recognized as revenue over the next 12 months (4.0 million), with a smaller portion being realized thereafter (0.8 million).

Disaggregation of revenue

Three months

Three months

Six months

Six months

ended

ended

ended

ended

    

June 30, 2023

    

June 30, 2022

    

June 30, 2023

    

June 30, 2022

Geographic information

Revenue:

 

  

 

  

 

  

 

  

Germany

 

0

 

14

 

0

 

151

USA

 

1,390

 

7,287

 

5,900

 

15,156

1,390

 

7,301

 

5,900

 

15,307

Major service lines:

 

 

Collaboration revenue

 

1,215

 

7,284

 

5,671

 

15,153

Service revenue

 

175

 

17

 

229

 

154

 

1,390

 

7,301

 

5,900

 

15,307

Timing on revenue recognition:

Point in time

 

0

 

0

 

0

 

0

Over time

 

1,390

 

7,301

 

5,900

 

15,307

 

1,390

 

7,301

 

5,900

 

15,307

4.      Operating loss

In April 2023, Affimed conducted a reorganization of its operations to focus on the Group’s three clinical stage development programs. As a result of the reorganization, the Group incurred a one-time expenditure for termination payments of 1.1 million during the three and six months ended June 30, 2023. Certain of these termination payments have already been settled and the balance will be settled in the second half of 2023. However, all of these termination payments have already been accrued for in calculating operating loss for the three and six months ended June 30,2023.

5.     Finance income and finance costs

Three months ended

  

Three months ended

  

Six months ended

  

Six months ended

    

June 30, 2023

    

June 30, 2022

    

June 30, 2023

    

June 30, 2022

Interest SVB Loan Agreement

 

(470)

 

(381)

 

(947)

 

(759)

Foreign exchange differences

 

121

 

2,653

 

(431)

 

3,568

Other finance income/finance costs - net

 

396

 

(19)

 

906

 

(85)

47

2,253

(472)

2,724

6.     Long- term financial assets

The Group holds preferred shares in Amphivena, which are currently recognized at their fair value of nil. The impairment of the asset was recognized in 2021 based on the decision made by the board of Amphivena to wind down the company. Based on current information, we continue to estimate that the fair value remains at nil (December 31, 2022: nil).

7.     Trade and other receivables

The trade receivables as of June 30, 2023 were 10 (December 31, 2022: 0). These trade receivables are all due in the short-term, do not bear interest and are not impaired. Other receivables are all due within the short-term and mainly comprise value-added tax receivables of 0.9 million (December 31, 2022: 1.5 million).

8

8.     Other assets and prepaid expenses

The other assets and prepaid expenses as of June 30, 2023 of 7.9 million (December 31, 2022: 2.5 million) are short-term in nature, do not bear interest and are not impaired. The other assets and prepaid expenses mainly comprise a prepayment of 3.2 million for clinical trial management services and 0.7 million for reservation for toxicity study capacity (December 31, 2022: 1.1 million for the reservation of manufacturing capacity), a directors and officers’ liability insurance premium of 1.2 million (December 31, 2022: 0 million) and 1.5 million (December 31, 2022: 0.5 million) prepayment for assets secured for new premises.

9.     Equity

As of June 30, 2023, the share capital of 1,493 (December 31, 2022: 1,493) is comprised of 149,339,335 (December 31, 2022: 149,339,335) common shares with a par value of 0.01 per share.

On April 18, 2022, the Company closed its public offering of 25,875,000 common shares (including over-allotment shares) at the public offering price of $4.00 per share, generating net proceeds of 89.8 million ($97.1 million), after deducting 6.0 million ($6.5 million) in underwriting commissions and other offering expenses.

10.     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, certain members of the Company’s Supervisory Board, non-employee consultants and employees.

Share-based payments with service conditions

The majority of the awards vest in instalments over three years and can be exercised up to 10 years after the grant date. The Group granted 384,000 and 8,052,750 awards for the three and six months ended June 30, 2023 to employees, members of the Management Board and members of the Supervisory Board. Fair value of the awards at grant date in the three and six months ended June 30, 2023 amounts to 0.2 million ($0.2 million) and 5.9 million ($6.3 million). 217,725 and 368,540 ESOP 2014 awards were cancelled or forfeited due to termination of employment during the three and six months ended June 30, 2023 (June 30, 2022: 13,926 and 99,591). During the three and six months ended June 30, 2023, no options were exercised (June 30, 2022: 18,994 and 43,440 options at a weighted average share price of $2.26 and $2.52).

As of June 30, 2023, 22,953,944 ESOP 2014 options were outstanding (December 31, 2022: 15,269,734), and 11,169,133 awards had vested (December 31, 2022: 8,510,863). The options outstanding as of June 30, 2023 had an exercise price in the range of $0.60 to $13.47 and a weighted average remaining contractual life of 7.7 years (December 31, 2022: 7.4 years) and a weighted average exercise price of $3.55 (December 31, 2022: $4.91).

Share-based payments with market condition

During 2022, the Company issued 2,825,000 options (1,325,000 awards in the first quarter and 1,500,000 awards in the second quarter of 2022), with market-based performance conditions to members of the Management Board and employees. Each grant consists of three tranches, whereby one-third of the total grant will vest when the volume-weighted average share price over the preceding thirty trading days reaches $12.00, $15.00, and $18.00, respectively. Except with respect to a change of control, these options shall not vest before the first anniversary of the grant date. As of June 30, 2023, no options were cancelled, forfeited or exercised.

Fair value at grant date of the awards granted in the three and six months ended June 30, 2022 amounts to 1.4 million ($1.8 million) and 2.9 million ($3.2 million). The contractual lifetime of the options is two years. Any unvested awards on the date that is two years following the grant date will lapse.

9

Share-based payment expense

In the three and six months ended June 30, 2023, compensation expense of 3,231 (including an accelerated expense due to the reduction of the Company’s headcount in the course of the reorganization) and 7,389 was recognized affecting research and development expenses (1,709 and 4,022) and general and administrative expenses (1,523 and 3,368). In the three and six months ended June 30, 2022, compensation expense of 5,625 and 9,872 was recognized affecting research and development expenses (2,889 and 5,194) and general and administrative expenses (2,736 and 4,678).

Fair value measurement

The fair value of options with service conditions granted in the six months ended June 30, 2023 and 2022, respectively, was determined using the Black-Scholes-Merton valuation model. The significant inputs into the valuation model are as follows (weighted average):

    

June 30, 2023

    

June 30, 2022

Fair value at grant date

$

0.79

$

3.30

Share price at grant date

$

1.05

$

4.45

Exercise price

$

1.05

$

4.45

Expected volatility

 

90

%

 

90

%

Expected life

 

5.86

 

5.87

Expected dividends

 

0.00

 

0.00

Risk-free interest rate

 

3.95

%

 

2.22

%

The fair value of options with market conditions granted in the six months ended June 30, 2022, was determined using a Monte Carlo simulation. The significant inputs into the valuation model are as follows (weighted average):

    

June 30, 2022

 

Fair value at grant date

$

1.13

Share price at grant date

$

4.58

Exercise price

$

4.58

Expected volatility

 

70

%

Expected life

 

2.00

Expected dividends

 

0.00

Risk-free interest rate

 

2.41

%

Expected volatility is estimated based on the observed daily share price returns of Affimed 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 (as best available indication for risk-free rates), for a term equal to the expected life, as measured as of the grant date.

11.     Borrowings

Silicon Valley Bank

In January 2021, the Group entered into a new loan agreement with Silicon Valley Bank German Branch (now: Silicon Valley Bridge Bank N.A. Germany Branch) or “SVB” which provides Affimed with up to 25 million in term loans in three tranches: 10 million available at closing, an additional 7.5 million upon the achievement of certain conditions, including milestones related to Affimed’s pipeline and market capitalization, and a third tranche of 7.5 million upon the achievement of certain additional conditions related to Affimed’s pipeline and liquidity. The first tranche of 10 million was drawn in February 2021 and the second tranche of 7.5 million in December 2021. Pursuant to the terms of the agreement, the loan bears interest at the greater of the European Central Bank Base Rate and 0%, plus 5.5%. Affimed was entitled to make interest only payments through December 1, 2022. The loan will mature at the end of November 2025. As of June 30, 2023, the fair value of the liability did not differ significantly from its carrying amount.

10

The loan is secured by a pledge of 100% of the Group’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 interim financial statements.

In July 2023, Bootstrap Europe announced the acquisition of SVB. The loan agreement is expected to be transferred to Bootstrap Europe with no change in the terms of the loan agreement.

UniCredit Leasing CZ

In April 2019, the Group entered into a loan agreement with UniCredit Leasing CZ for 562. After an initial instalment of 127 in the second quarter of 2019, repayment is effected in monthly instalments of 8 until May 2024. As of June 30, 2023, an amount of 89 (December 31, 2022: 136) was outstanding, of which  89 was classified as current liabilities (December 31, 2022: 96). As of June 30, 2023, the fair value of the liability did not differ significantly from its carrying amount.

12.     Related parties

The supervisory board directors of Affimed N.V. received compensation in the amounts of 114 and 238 (107 and 216) for their services on the Supervisory Board in the three and six months ended June 30, 2023 (2022). Members of the Management Board received compensation in the amounts of 972 and 1,916 (936 and 1,829) for their services on the Management Board in the three and six months ended June 30, 2023 (2022).

The Company recognized share-based payment expenses of 83 and 195 (719 and 998) for supervisory directors and 1,317 and 2,954 (1,816 and 3,389) for managing directors in the three and six months ended June 30, 2023 (2022).

The following table provides the total amounts of outstanding balances for supervisory board compensation and expense reimbursement related to key management personnel:

Outstanding balances

June 30, 

December 31, 

    

2023

    

2022

Adi Hoess

 

-

 

1

Wolfgang Fischer

-

2

Arndt Schottelius

-

3

Thomas Hecht

 

20

 

21

Mathieu Simon

 

9

 

10

Ulrich Grau

 

22

 

26

Bernhard Ehmer

12

17

Harry Welten

9

8

Annalisa Jenkins

11

11

Uta Kemmerich-Keil

 

17

 

18

Constanze Ulmer-Eilfort

5

-

11

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 condensed consolidated interim financial statements for the three and six month periods ended June 30, 2023 and 2022 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 2022, and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2022 (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. We maintain our books and records in Euros. 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 discussion 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 for collaborative research and development services. Through June 30, 2023, we have raised an aggregate of approximately €570.4 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 June 30, 2023, we had an accumulated deficit of €491.6 million.

Notwithstanding our collaborations with Genentech Inc. (“Genentech”) and Roivant Sciences Ltd. (“Roivant”), 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 regulatory 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 capital. 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.

1


In 2009, we formed AbCheck s.r.o., our 100% owned, independently run antibody screening platform company, located in the Czech Republic. AbCheck discovers and optimizes human therapeutic antibodies with a versatile technology platform. Tailored to the specific needs of its customers and their desired target product profiles, AbCheck designs a personalized approach leveraging both cutting edge (e.g., microfluidics, rabbit mass humanization) and classical (e.g., phage/yeast display libraries) technologies to provide high quality leads. In addition to providing candidates for Affimed projects, AbCheck has multiple partnerships throughout the U.S. and Europe with globally active pharmaceutical and biotechnology companies such as Tusk Therapeutics, bluebird bio, Eli Lilly, Daiichi Sankyo, Pierre Fabre and others. We have one U.S. subsidiary, Affimed Inc., with senior employees in finance, investor relations, business development, corporate strategy, communication and medical/clinical operations.

Recent Developments

In January 2023, the FDA issued a written response to our pre-investigational new drug (“IND”) meeting request for the AFM13 and Artiva AB-101 co-administered combination therapy in relapsed/refractory Hodgkin lymphoma and the exploratory arm evaluating the combination in r/r CD30-positive peripheral T-cell lymphoma.

In March 2023, we announced that the first patient was dosed in a phase 1 multicenter, open label, first-in-human dose escalation study of the innate cell engager (ICE®) AFM28 monotherapy in patients with CD123-positive relapsed/refractory (r/r) acute myeloid leukemia (AML). AFM28 efficiently directs natural killer (NK) cells to CD123-positive leukemic cells in our preclinical models, including blasts and leukemic stem and progenitor cells, inducing their depletion in samples of patients with AML and myelodysplastic syndrome (MDS).

In April 2023, we received a written notice (the “Notice”) from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, for the last thirty consecutive business days, the bid price for the Company’s common shares had closed below the minimum $1.00 per share requirement for continued listing on the Nasdaq under Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Rule”). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial period of 180 calendar days, or until October 2, 2023, to regain compliance. If the Company fails to regain compliance with the Minimum Bid Price Rule during this period, the Company may consider applying to transfer its securities from The Nasdaq Global Select Market to The Nasdaq Capital Market, provided that the Company meets the applicable market value of publicly held shares required for continued listing and all other applicable requirements for initial listing on The Nasdaq Capital Market (except for the bid price requirement). Such transfer would provide the Company with an additional 180 calendar days, or until April 1, 2024, to regain compliance. There can be no assurance that the Company would be eligible for the additional 180 calendar day compliance period, if applicable, or that the Nasdaq staff would grant the Company’s request for continued listing. The Notice has no immediate effect on the listing or trading of the Company’s common shares. The Company intends to monitor the bid price of its common shares and consider available options to regain compliance with the Minimum Bid Price Rule, such as effecting a reverse stock split, for which authorization was given during the Company’s annual shareholder meeting 2023.

In April 2023, we announced the final results from our phase 2 REDIRECT study investigating our innate cell engager (ICE®) AFM13 monotherapy in patients with heavily pretreated advanced-stage r/r PTCL. The results were presented at the American Association for Cancer Research (AACR) Annual Meeting by Dr. Won Seog Kim, Professor of Hematology-Oncology at Samsung Medical Center in Seoul and a principal investigator for the study, and established that AFM13 monotherapy showed efficacy in the treatment of relapsed/refractory peripheral T cell lymphoma (r/r PTCL) patients with a differentiated safety profile. As stated above, primary efficacy measures include an ORR of 32.4% and a CR rate of 10.2%. Key secondary and exploratory outcome measures include safety, durability of response, progression free survival and overall survival. Median DoR was 2.3 months, median PFS was 3.5 months and median OS was 13.8 months. PFS and OS were comparable with currently approved therapies for r/r PTCL. Of all PTCL subsets, patients with AITL exhibited the highest ORR (53.3%) and CR (26.7%) with DoR not meaningfully different across the various subsets. The safety profile of AFM13 was well managed and consistent with previously reported data of prior and ongoing clinical studies with AFM13. Most common TEAEs were IRR (25%), neutropenia (10.2%) and pyrexia (8.3%). No AFM13-related fatal toxicities were observed.

In April 2023, Affimed conducted a reorganization of its operations to focus on the Company’s three clinical stage development programs. As a result of the reorganization, the Group reduced its full-time equivalent headcount by approximately 25%. As a result of the reorganization, the Group incurred a one-time expenditure for termination payments of €1.1 million during the three and six months ended June 30, 2023. Affimed expects this one-time cash expenditure to be offset by cost savings during the remainder of 2023.

In May 2023, we announced the FDA clearance of our IND application for a clinical study evaluating the combination of AFM13, and AB-101, AFM13-203. The phase 2 study will be open-label, multi-center, multi-cohort study with a run-in phase followed by a dose optimization and an expansion phase. The study will evaluate the safety and efficacy of AFM13 in combination with AB-101 in patients

2


with relapsed / refractory classical HL (cHL) and CD30-positive PTCL. The activation of the first study sites is expected to be in September/October 2023 and we expect to report initial data in the first half of 2024.

In June 2023, at the American Society of Clinical Oncology (ASCO) Annual Meeting we presented safety and efficacy data from the EGFR mutant NSCLC expansion cohort of our ongoing AFM24-101 phase 1/2 study investigating innate cell engager (ICE®) AFM24 as monotherapy. The AFM24 EGFR mutant NSCLC cohort is part of the AFM24-101 open-label, non-randomized, multi-center, phase 1/2a study (NCT04259450) investigating the safety, tolerability, and preliminary efficacy of AFM24 monotherapy in patients with advanced or metastatic EGFR+ solid tumors. Other cohorts being investigated included colorectal cancer (CRC) and renal carcinoma (RCC). At the planned interim analysis, 15 patients with EGFR mutant NSCLC and a median of 2 prior lines of therapy had been treated with a median of 11 doses of AFM24. As of the cut-off date, the data showed clinical activity and signals of anti-tumor activity in 7 out of 15 heavily pre-treated patients, including two confirmed partial responses and five patients with stable disease resulting in an objective response rate of 13% and a disease control rate of 47%. Concurrent with the presentation, we announced our intention to focus near-term clinical development of AFM24 on the combination with atezolizumab (AFM24-102), and announced the discontinuation of both AFM24-101 and AFM24-103 (combination with SNK01 autologous NK cells).

In July 2023, we announced that an abstract with clinical trial results of our ICE® AFM24 in combination with NKGen Biotech’s SNK01 (autologous non-genetically modified NK cells), has been accepted for a poster presentation at the ASCO Breakthrough conference from 3-5 August 2023 in Yokohama, Japan. The presentation includes dose escalation phase data on safety and efficacy of the ICE® AFM24 phase 1 study in patients with advanced or metastatic EGFR-expressing solid tumors (NCT05099549). As of June 2023, seven patients with a mean number of five prior therapies received the combination of AFM24 and SNK01. No unexpected or dose-limiting toxicities were observed, and the PK properties were similar to AFM24 monotherapy. The best objective response was stable disease in three out of the seven patients, including patients with heavily pretreated microsatellite stable colorectal cancer (MSS CRC). Despite these data, Affimed and NKGen Biotech mutually decided to discontinue the presented study. In line with Affimed’s NK cell combination experience for AFM13, Affimed is currently evaluating the best option to advance AFM24 with an allogeneic off-the-shelf NK cell product.

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.

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 widely from period to period. Our research and development expense mainly relates to the following key programs:

·

AFM13. The following is a summary of completed and ongoing research and development activities for AFM13:

·

In January 2023, the U.S. Food and Drug Administration (“FDA”) issued a written response to our pre-investigational new drug (“IND”) meeting request for the AFM13 and Artiva Biotherapeutics, Inc. AB-101 co-administered combination therapy in relapsed/refractory Hodgkin lymphoma and the exploratory arm evaluating the combination in r/r CD30-positive peripheral T-cell lymphoma. Based on the written response, Affimed submitted and received clearance from FDA for an IND application during the second quarter of 2023 and expects the activation of the first clinical sites in September/October 2023.

·

In December 2022, we provided a data update from the ongoing phase 1/2 study of the Company’s lead innate cell engager (ICE®) AFM13 precomplexed with cord blood-derived natural killer (cbNK) cells in patients with CD30-positive relapsed or refractory (R/R) Hodgkin and Non-Hodgkin lymphomas. Key observations as of the cutoff date include:

o

35 Hodgkin lymphoma and Non-Hodgkin lymphoma patients treated at the recommended phase 2 dose (RP2D) showed an objective response rate (ORR) of 94% and a complete response (CR) rate of 71%. 63% of patients treated at the RP2D with at least 6 months follow-up after initial infusion (n=24) remain in complete response for at least 6 months. The treatment continues to be well tolerated in the larger patient population, with minimal side effects beyond the expected myelosuppression from the preceding lymphodepleting chemotherapy. No instances of cytokine release syndrome, immune effector cell-associated neurotoxicity syndrome, or graft versus host

3


disease were observed. There were 20 infusion-related reactions in 294 infusions (6.8%) of AFM13 alone and one infusion-related reaction in 99 infusions (1%) of the cbNK cells precomplexed with AFM13. No dose-limiting toxicities were encountered.

·

In December 2022, we released topline data from our phase 2 REDIRECT study investigating AFM13 monotherapy in patients with advanced-stage R/R Peripheral T Cell Lymphoma. Primary efficacy measures include objective response rate of 32.4% and a CR rate of 10.2%. Key secondary and exploratory outcome measures include safety, durability of response, progression free survival (PFS) and overall survival (OS). The safety profile of AFM13 was well managed and consistent with previously reported data of prior and ongoing clinical studies with AFM13. Median duration of response (DoR) was 2.3 months, median PFS was 3.5 months and median OS was 13.8 months. Based on the compelling data seen in Hodgkin lymphoma for the combination of AFM13 with cord blood-derived NK cells in the AFM13-104 study, we believe that the combination with AB-101 has a higher probability to deliver increased anti-tumor activity and a more durable clinical benefit to address the unmet need in this patient population. Accordingly, we do not intend to pursue an accelerated approval for AFM13 monotherapy in PTCL and will focus investment on clinical development in the combination of AFM13 with Artiva’s AB-101 NK cell product.

·

In November 2022, we announced a new strategic partnership with Artiva Biotherapeutics (“Artiva”) to jointly develop, manufacture, and commercialize a combination therapy of ICE® AFM13 and Artiva’s cord blood-derived, cryopreserved off-the-shelf allogeneic NK cell product candidate, AB-101. Under the terms of the agreement, Affimed and Artiva will pursue the development of the AFM13/AB-101 combination treatment in the United States on a co-exclusive basis. Affimed will lead regulatory activities through Phase 2 and any confirmatory studies. Affimed will be responsible for funding clinical study costs through Phase 2, while Artiva will be responsible for the costs of supplying AB-101 and IL-2 for such studies. The companies will share confirmatory study costs on a 50/50 basis. Both companies will retain commercialization and distribution rights and book sales for their respective products. Affimed will be responsible for promotional activities and expenses of the combination therapy. Pursuant to the agreement, revenues from the combination will be shared, with Affimed receiving 67% of the combination therapy revenue and Artiva receiving 33%.

We anticipate that our research and development expenses in 2023 for AFM13 will increase compared to those for 2022 due to the continuation of the existing clinical studies and the initiation of a new clinical study, pre-clinical studies and the scale-up of the production of AFM13 for commercial purposes.

·

AFM24. AFM24, a tetravalent, bispecific epidermal growth factor receptor, and CD16A-binding innate cell engager. Affimed reported data from the phase 2a phase of its ongoing monotherapy study at the American Society of Clinical Oncology Annual Meeting in June 2023. At the planned interim analysis, 15 patients with EGFR mutant NSCLC and a median of 2 prior lines of therapy had been treated with a median of 11 doses of AFM24. As of the cut-off date, the data showed clinical activity and signals of anti-tumor activity in 7 out of 15 heavily pre-treated patients, including two confirmed partial responses and five patients with stable disease resulting in an objective response rate of 13% and a disease control rate of 47%. In addition, Affimed reported data from its combination study with SNK01 in July 2023 and expects to report data from its combination study with atezolizumab in the fourth quarter of 2023. We anticipate that our research and development expenses in 2023 for AFM24 will increase compared to those in 2022.

·

AFM28. AFM28 is designed to bind to CD123, an established target in myeloid malignancies. We chose CD123 as it is almost universally expressed on leukemic blasts and leukemic stem cells in patients with AML, both at diagnosis and at relapse, and independently of cytogenetic risk. AFM28 is being developed for the treatment of patients with acute myeloid leukemia. In June 2022, we submitted an IND to the FDA for AFM28. Following feedback from the FDA related to the design of the dose escalation study, we made a strategic decision to voluntarily withdraw the IND and to focus early clinical development of AFM28 in jurisdictions outside of the U.S. The Company initiated recruitment into a phase 1 clinical study in the first quarter of 2023.

·

Other projects and infrastructure costs. Our other research and development expenses relate to our Roivant and Artiva collaborations, 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 decrease in 2023 due to decreased early-stage development/discovery activities and the reorganization as already mentioned under recent developments.

4


Results of Operations

The financial information shown below was derived from our unaudited interim consolidated financial statements for the three month periods ended June 30, 2023 and 2022. 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 June 30, 2023 and 2022

    

Three months ended June 30,

2023

    

2022

(unaudited)

(in € thousand)

Total Revenue

1,390

7,301

Other income (expenses)—net

717

240

Research and development expenses

(25,273)

(20,829)

General and administrative expenses

(6,276)

(8,374)

Operating loss

(29,442)

(21,662)

Finance income/(costs)—net

47

2,253

Loss before tax

(29,395)

(19,409)

Income taxes

0

0

Loss for the period

(29,395)

(19,409)

Other comprehensive loss

0

(599)

Total comprehensive loss

(29,395)

(20,008)

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

(0.20)

(0.13)

Revenue

Revenue decreased to €1.4 million in the three months ended June 30, 2023 from €7.3 million for the three months ended June 30, 2022. Revenue in the three months ended June 30, 2023 relates predominantly to the Roivant collaboration with €1.1 million, while 2022 predominantly related to the Genentech and Roivant collaborations with €3.3 million and €4.0 million respectively. Revenue from the Roivant collaboration in the three months ended June 30, 2023 was comprised of revenue recognized for collaborative research services performed during the quarter. Revenue from the Genentech collaboration declined as compared to the prior year period due to the fact that, as of the end of 2022, Affimed had completed work on and/or handed over all product candidates for further investigation by Genentech.

Research and development expenses

    

Three months ended June 30

2023

    

2022

    

Change %

Unaudited

R&D Expenses by Project

(in € thousand)

Project

AFM13

8,132

2,334

248%

AFM24

5,455

5,110

7%

AFM28

1,393

1,753

(21%)

Other projects and infrastructure costs

8,584

8,742

(2%)

Share-based payment expense

1,709

2,890

(41%)

Total

25,273

20,829

21%

5


Research and development expenses amounted to €25.3 million in the three months ended June 30, 2023 compared to research and development expenses of €20.8 million in the three months ended June 30, 2022. The variances in project-related expenses between the projects for the three months ended June 30, 2023 and the corresponding period in 2022 are mainly due to the following:

·

AFM13. In the three months ended June 30, 2023 we incurred higher expenses (248%) than in the three months ended June 30, 2022 primarily due to the increase of costs for clinical trial material, the scale-up of manufacturing of AFM13 for commercial purposes  and clinical trial costs.

·

AFM24. In the three months ended June 30, 2023, we incurred higher expenses (7%) than in the three months ended June 30, 2022 due to the continued enrollment of patients in our ongoing phase 1/2a clinical trials and manufacturing activities for clinical trial material required for the ongoing studies.

·

AFM28. In the three months ended June 30, 2023, we incurred lower expenses (21%) than in the three months ended June 30, 2022 due to lower costs for preclinical development activities.

·

Other projects and infrastructure costs. In the three months ended June 30, 2023, expenses were slightly lower (2%) than in the three months ended June 30, 2022. A one-time termination expenditure was incurred in the three months ended June 30, 2023 due to the reorganization of the Group, but these costs were offset by a decline in costs incurred with respect to certain of our collaboration projects, such as the Roivant collaboration, which is coming to an end.

General and administrative expenses

General and administrative expenses amounted to €6.3 million in the three months ended June 30, 2023 compared to €8.4 million in the three months ended June 30, 2022. The decrease of 25% was primarily due to a decline in legal and consulting expenses, as well as a decline in the share-based payment expense and insurance premiums. This decline, however, was partially offset by a one-time termination expenditure incurred as a result of the reorganization we conducted in April 2023.

Finance income / (costs)-net

Finance income for the three months ended June 30, 2023 totaled €0 million, compared to finance income of €2.3 million for the three months ended June 30, 2022. Finance income/costs in the three months ended June 30, 2023 and 2022 are primarily made up of foreign exchange gains / losses related to cash and cash equivalents denominated in U.S. dollars as a result of the change in the value of the U.S. dollar compared to the Euro.

Other comprehensive income/(loss)

The Group previously held common shares in Roivant, resulting in a fair value adjustment of €0.6 million for the three months ended June 30, 2022. These common shares were all sold in 2022, and accordingly no fair value adjustment has arisen in the three months ended June 30, 2023.

6


Comparison of the six months ended June 30, 2023 and 2022

    

Six months ended June 30,

2023

    

2022

(unaudited)

(in € thousand)

Total Revenue

5,900

15,307

Other income (expenses)—net

1,127

524

Research and development expenses

(54,804)

(39,208)

General and administrative expenses

(13,126)

(15,419)

Operating loss

(60,903)

(38,796)

Finance income/(costs)—net

(472)

2,724

Loss before tax

(61,375)

(36,072)

Income taxes

(3)

(2)

Loss for the period

(61,378)

(36,074)

Other comprehensive loss

0

(6,773)

Total comprehensive loss

(61,378)

(42,847)

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

(0.41)

(0.27)

Revenue

Revenue decreased from €15.3 million in the six months ended June 30, 2022 to €5.9 million for the six months ended June 30, 2023. Revenue in the six months ended June 30, 2023 relates predominantly to the Roivant collaboration with €5.4 million, while revenue in the six months ended June 30, 2022 predominantly related to the Genentech and Roivant collaborations with €7.3 million and €7.9 million respectively. Revenue from the Roivant collaboration in the six months ended June 30, 2023 was comprised of revenue recognized for collaborative research services performed during the six months. Revenue from the Genentech collaboration declined as compared to the prior year period due to the fact that, as of the end of 2022, Affimed had completed work on and/or handed over all product candidates for further investigation by Genentech.

Research and development expenses

    

Six months ended June 30

2023

    

2022

    

Change %

Unaudited

R&D Expenses by Project

(in € thousand)

Project

AFM13

16,844

4,356

287%

AFM24

12,068

9,273

30%

AFM28

3,205

4,460

(28%)

Other projects and infrastructure costs

18,665

15,925

17%

Share-based payment expense

4,022

5,194

(23%)

Total

54,804

39,208

40%

Research and development expenses increased from €39.2 million in the six months ended June 30, 2022 to €54.8 million for the six months ended June 30, 2023. The variances in project-related expenses between the projects for the six months ended June 30, 2023 and the corresponding period in 2022 are mainly due to the following:

·

AFM13. In the six months ended June 30, 2023 we incurred higher expenses (287%) than in the six months ended June 30, 2022 primarily due to an increase in overall clinical trial costs, the scale-up of manufacturing of AFM13 for commercial purposes as well as costs for clinical trial material.

·

AFM24. In the six months ended June 30, 2023, we incurred higher expenses (30%) than in the six months ended June 30, 2022 due to the continued enrollment of patients in our ongoing phase 1/2a clinical trials and associated manufacturing activities for the clinical trial material required for the ongoing studies.

7


·

AFM28. In the six months ended June 30, 2023, we incurred lower expenses (28%) than in the six months ended June 30, 2022 due to lower costs for preclinical development activities.

Other projects and infrastructure costs. In the six months ended June 30, 2023, expenses were higher (17%) than in the six months ended June 30, 2022 primarily due to higher expenses incurred in relation to our earlier stage programs, including our collaborations with Artiva, and discovery/early stage development activities and infrastructure costs. The increase is also a result of a one-time termination expenditure incurred due to the reorganization of the Group.

General and administrative expenses

General and administrative expenses amounted to €13.1 million in the six months ended June 30, 2023 compared to €15.4 million in the six months ended June 30, 2022. These costs have declined (15%) mainly as a result of a decline in legal and consulting expenses, as well as a decline in share-based payment expense and insurance premiums. This decline, however, was partially offset by a one-time termination expenditure incurred as a result of the reorganization.

Finance income / (costs)-net

Finance costs for the six months ended June 30, 2023 totaled €0.5 million, compared to finance income of €2.7 million for the six months ended June 30, 2022. Finance income/costs in the six months ended June 30, 2023 and 2022 are primarily made up of foreign exchange gains / losses related to cash and cash equivalents denominated in U.S. dollars as a result of the change in the value of the U.S. dollar compared to the Euro.

Other comprehensive income/(loss)

The Group previously held common shares in Roivant resulting in a fair value adjustment of €6.8 million for the six months ended June 30, 2022; these shares were all sold in 2022, and accordingly no fair value adjustment has arisen in the six months ended June 30, 2023.

Liquidity and Capital Resources

Since inception, we have not generated any revenue from product sales and we have incurred significant operating losses. We have funded our operations to date 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 six months ended June 30, 2023 and 2022:

    

Six months ended June 30,

2023

    

2022

(unaudited)

(in € thousand)

Net cash used in operating activities

(66,574)

(54,904)

Net cash used for/generated from investing activities

(11)

1,324

Net cash used in/generated from financing activities

(3,214)

89,614

Exchange rate related changes of cash and cash equivalents

(431)

3,568

Net changes to cash and cash equivalents

(69,799)

36,034

Cash and cash equivalents at the beginning of the period

190,286

197,630

Cash and cash equivalents at the end of the period

120,056

237,232

Net cash used in operating activities of €66.6 million in the six months ended June 30, 2023 is higher than net cash used in operating activities in the six months ended June 30, 2022 (€54.9 million) mainly due to higher cash expenditure for research and development. Net cash used in operating activities in the six months ended June 30, 2023 also includes changes in working capital totaling €13.9 million, primarily due to changes in other assets and prepaid expenses, trade and other payables as well as contract liabilities. Net cash used in operating activities for the remainder of 2023 is expected to decrease due to a continued reduction in operating expenses over the next several quarters due to the reorganization we conducted in April 2023, the completion of our work on the Genentech and Roivant collaborations, the completion or wind down of certain clinical activities such as AFM13-202, AFM13-104, AFM24-101 and AFM24-103, and the timing of certain manufacturing expenses for AFM13, which were weighted towards the first two quarters of 2023.

8


The investing activities in the six months ended June 30, 2023 primarily related to investment in acquisition of equipment, while the cash generated in investing activities for the six months ended June 30, 2022 were largely from the sale of the Roivant shares. Net cash used in financing activities in the six months ended June 30, 2023 (€3.2 million) resulted primarily from the payment of lease liabilities and the SVB loan, while the cash generated in the six months ended June 30, 2022 resulted primarily from the proceeds of a public equity offering.

Cash and Funding Sources

Our cash and cash equivalents as of June 30, 2023 were €120.1 million, compared with €190.3 million as of December 31, 2022. Funding sources generally comprise proceeds from the issuance of equity instruments, payments from collaboration agreements and loans.

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. In addition, we expect that we will require additional capital to commercialize our product candidates, including AFM13, AFM24 and AFM28. If we receive regulatory approval for AFM13, AFM24, AFM28 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, we believe that our existing liquidity will enable us to fund our operating expenses and capital expenditure requirements into 2025. 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;

·

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.

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.

9


Quantitative and Qualitative Disclosures About Market Risk

During the three months ended June 30, 2023, 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 consolidated financial statements for the three and six month periods ended June 30, 2023 and 2022 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 June 30, 2023, our accumulated deficit was €491.6 million;

·

the possibility that 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 AFM13, AFM24 and AFM28 (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;

·

the success of the Affimed-Artiva partnership, including in relation to the fact that the current clinical data of AFM13 in combination with NK cell therapy is based on AFM13 precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to AB-101, which is a cryopreserved allogeneic cord blood-derived NK cell that we anticipate will be co-administered with AFM13;

·

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

·

the outcome of 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;

10


·

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 Roivant, Artiva, The MD Anderson Cancer Center, and Genentech and the potential failure to enter into new strategic relationships or difficulties with our strategic partners that may slow the progress of our joint developments or lead to the termination of a partnership and the need to enter into a new one, all of which could take substantial time and attention of our management team;

·

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 pandemic and its impact on our business, including our supply chain, clinical trials and operations;

·

the impact on our business of macroeconomic trends, political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict and the instability in the banking sector experienced in the first quarter of 2023; 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 COVID-19 pandemic. 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.

11


Exhibit 99.3

Graphic

PRESS RELEASE

Affimed Reports Second Quarter 2023 Financial Results and Highlights

Operational Progress

AFM13 combination with AB-101 NK cells (LuminICE-203): On track to report initial efficacy and safety data in the first half 2024; Type C meeting request submitted to FDA to clarify requirements for accelerated approval.
AFM24 monotherapy: Clinical activity in 7 out of 15 heavily pretreated patients with EGFRmut non-small cell lung cancer (NSCLC), including 2 confirmed partial responses.
AFM24 combinations: Affimed plans to report data from the combination with atezolizumab in the fourth quarter 2023; data from combination study with SNK01 were presented at ASCO Breakthrough.
AFM28: Cleared second dose cohort without dose limiting toxicities in phase 1 dose escalation study in patients with CD123-positive relapsed/refractory (r/r) acute myeloid leukemia (AML); enrolling patients in third cohort.
Cash runway into 2025: As of June 30, 2023, cash and cash equivalents were €120.1 million.

Heidelberg, Germany, August 10, 2023 – Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results and provided an update on clinical and corporate progress for the second quarter of 2023.

“Affimed continues to make important progress across all three of our clinical assets, setting the stage for a catalyst-rich next 12 months,” said Dr. Adi Hoess, CEO of Affimed. “This includes data in the first half of 2024 from the LuminICE-203 trial of AFM13 which builds upon our unprecedented proof of concept data. For AFM24, we plan to present data later this year from the combination with atezolizumab. Finally, we are rapidly advancing our phase 1 study for AFM28 towards what we believe could be therapeutic dose levels.”

Program Updates

AFM13 (CD30/CD16A)

Investigational new drug (IND) application cleared by FDA for LuminICE-203, a phase 2 clinical study to investigate AFM13 in combination with Artiva’s AB-101 natural killer (NK) cells. LuminICE-203 will investigate the combination therapy of AFM13 and AB-101 in patients with r/r classical Hodgkin lymphoma (HL). The study will also include a cohort of 20 r/r PTCL patients. Affimed is in the final stages of site


activation and expects to have the first sites open in September/October. The Company is on track to report initial data in the first half of 2024.

Type C meeting request submitted to FDA to further discuss the requirements for an accelerated approval based on the LuminICE-203 study. Affimed expects to gain further insight from the agency on the requirements for a registration application in the U.S. Based on FDA guidelines, Affimed expects the meeting to be held in the fourth quarter of 2023.

Preclinical data presented at the International Conference on Malignant Lymphoma showed that AFM13 binds homogeneously to thawed AB-101, guiding NK cells to CD30-positive tumor cells, and boosting AB-101's cytotoxic activity against these cells. This effect was accompanied by increased functional activation of AB-101, evidenced by degranulation and IFN-γ production. Furthermore, tumor growth control was achieved by combining AFM13 with AB-101 in a mouse xenograft model.

AFM13-203 (LuminICE-203) will build on data generated from the Company’s AFM13-104 study which demonstrated the promise of AFM13 in combination with cord blood-derived NK (cbNK) cells for the treatment of r/r HL and non-Hodgkin lymphoma (NHL) patients. Data from the study, presented at the American Society of Hematology 2022 annual meeting, demonstrated a 94% objective response rate (ORR) and a complete response rate (CR) rate of 71% in 35 heavily pre-treated CD30-positive HL and Non-Hodgkin lymphoma (NHL) patients treated at the recommended phase 2 dose (RP2D). 63% of patients (n=24) treated at the RP2D with at least 6 months of follow-up after the initial infusion remained in CR for at least 6 months. In addition, the treatment was well tolerated with no cases of cytokine release syndrome, immune effector cell-associated neurotoxicity or graft versus host disease observed. A data update from the AFM13-104 study is expected at ASH in December, including a longer follow-up of patients.

AFM24 (EGFR/CD16A)

Presented clinical data from the ongoing AFM24 trials at the American Society of Clinical Oncology. Update from AFM24-101 phase 1/2 monotherapy study included 15 patients from the EGFR mutant NSCLC cohort showed AFM24 clinical activity in 7 out of 15 heavily pre-treated patients with tumor reductions, including 2 confirmed partial responses and 5 patients exhibiting stable disease. Based on the data, the Company decided to focus near-term development efforts on advancing AFM24 in combination with checkpoint inhibitors as part of its ongoing AFM24-102 study to further investigate the synergies between AFM24 and atezolizumab. As a result, enrollment in the monotherapy study and the combination of AFM24 with autologous NK cells will be terminated.

Enrollment ongoing for the Phase 1/2a combination study of AFM24 and atezolizumab, an anti-PD-L1 checkpoint inhibitor, in patients with advanced EGFR-expressing solid tumors. Expansion cohorts for AFM24-102 initiated during the first


quarter 2023 and are actively enrolling patients with (1) EGFR-wildtype NSCLC (2) gastric /gastroesophageal junction adenocarcinoma and (3) a basket cohort evaluating pancreatic, hepatocellular, and biliary tract cancer. Based on the results from the monotherapy study, a fourth expansion cohort of patients with EGFR-mutant NSCLC has been added to the AFM24-102 study and is open for recruitment. Interim data from the first three cohorts is expected in the fourth quarter 2023.

Phase 1/2a combination data from the AFM24 and SNK01, NKGen Biotech’s ex vivo expanded and activated autologous NK cell therapy was recently presented at ASCO Breakthrough. In the study, seven patients with a mean number of five prior therapies received the combination of AFM24 and SNK01. No unexpected or dose-limiting toxicities were observed, and the PK properties of AFM24 were similar to AFM24 monotherapy. The best objective response was stable disease in three out of the seven patients, including patients with heavily pretreated microsatellite stable colorectal cancer (MSS CRC). This data forms the basis for a potential combination of AFM24 with an allogeneic, off-the-shelf NK cell product.

AFM28 (CD123/CD16A)

AFM28-101, a multi-center Phase 1 open label, dose escalation study of AFM28 monotherapy is treating patients with CD123-positive r/r AML. The second dose cohort was completed without any dose limiting toxicities. Currently, patients are being treated in the third dose cohort. Clinical development of AFM28 is planned as both single-agent and in combination with an allogeneic off-the-shelf NK cell product.

Partnerships and Collaborations

Affimed has completed its work on novel molecules for both Genentech and Affivant. Further development of these product candidates is at the discretion of the respective companies.

Potential Upcoming Milestones:

Follow-up data from AFM13-104 expected at ASH in December 2023
Based on FDA guidelines, Type C meeting for LuminICE-203 is expected in the fourth quarter 2023
Data from Phase 1/2a AFM24+atezolizumab combination study planned in the fourth quarter 2023
Further progress updates from AFM28-101 dose escalation expected in the second half 2023
Initial data readout from the LuminICE-203 study expected in the first half 2024

Second Quarter 2023 Financial Highlights

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


As of June 30, 2023 cash and cash equivalents totaled €120.1 million compared to €190.3 million on December 31, 2022. Based on our current operating plan and assumptions, we anticipate that our cash and cash equivalents will support operations into 2025.

Net cash used in operating activities for the quarter ended June 30, 2023 was €33.3 million compared to €26.5 million for the quarter ended June 30, 2022. Operating cash flow for the quarter ended June 30, 2023 was adversely impacted by a change in working capital of €7.5 million, primarily due to €4.3 million for changes in trade and other payables and €2.7 million for changes in other assets and prepaid expenses. The change in trade and other payables was driven primarily by payment of manufacturing costs for AFM13 and AFM24 that were expensed in prior periods, while the change in other assets and prepaid expenses was driven by €3.1 million of prepayments associated with the AFM13 LuminICE-203 trial, partially offset by the reduction in the amount of certain insurance prepayments.

Total revenue for the quarter ended June 30, 2023, was €1.4 million compared with €7.3 million for the quarter ended June 30, 2022. Revenue in 2022 and 2023 predominantly relates to the Roivant and Genentech collaborations.

Research and development expenses for the quarter ended June 30, increased by 21.3% from €20.8 million in 2022 to €25.3 million in 2023. The increase was primarily due to higher expenses associated with the development of the AFM13 and AFM24 programs, a result of an increase in procurement of clinical trial material, increased clinical trial costs and manufacturing costs and, an increase in costs associated with other early-stage programs and infrastructure.

General and administrative expenses decreased 25.1% from €8.4 million in the quarter ended June 30, 2022, to €6.3 million in the quarter ended June 30, 2023. The decrease was due to a decline in legal, consulting and insurance expenses, as well as share-based payment expenses.

Net finance income/costs for the quarter ended June 30, 2023 decreased from income of €2.3 million in the quarter ended June 30, 2022, to income of €0.0 million in the quarter ended June 30, 2023. Net finance income/costs are largely due to foreign exchange gains/losses related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and Euro during the year.

Net loss for the quarter ended June 30, 2023, was €29.4 million, or €0.20 loss per common share compared with a net loss of €19.4 million, or €0.13 loss per common share, for the quarter ended June 30, 2022.

The weighted number of common shares outstanding for the for quarter ended June 30, 2023 was 149.3 million.

Additional information regarding these results will be included in the notes to the consolidated financial statements as of June 30, 2023, included in Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).

Note on International Financial Reporting Standards (IFRS)

Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB. None of the financial statements were


prepared in accordance with U.S. Generally Accepted Accounting Principles. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information

Affimed will host a conference call and webcast on August 10, 2023, at 8:30 a.m. EDT / 14:30 CET to discuss second quarter 2023 financial results and corporate developments.

The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the “Webcasts” section on the “Investors” page of the Affimed website at https://www.affimed.com/investors/webcasts-and-corporate-presentation/. To access the call by phone, please use link:

https://register.vevent.com/register/BI1a95f0d05ae14e099ffc1c7872731338, and you will be provided with dial-in details and a pin number.

Note: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call.

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s proprietary ROCK® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK® platform predictably generates customized innate cell engager (ICE®) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE®. Headquartered in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: www.affimed.com.

Forward-Looking Statement

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 the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, AFM28 and the Company’s other product candidates, the value of its ROCK® platform, its ongoing and planned preclinical development and clinical trials, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future


transactions, growth and strategies, the industry in which it operates, the macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict, the fact that the current clinical data of AFM13 in combination with NK cell therapy is based on AFM13 precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AB-101 and other uncertainties and 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 the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.

Investor Relations Contact

Alexander Fudukidis

Director, Investor Relations

E-Mail: a.fudukidis@affimed.com

Tel.: +1 (917) 436-8102


Affimed N.V.

Unaudited consolidated interim statements of comprehensive loss

(in € thousand)

For the three months ended

For the six months ended

June 30

June 30

    

2023

    

2022

    

2023

    

2022

Revenue

1,390

7,301

5,900

15,307

Other income – net

 

717

 

240

 

1,127

 

524

Research and development expenses

 

(25,273)

 

(20,829)

 

(54,804)

 

(39,208)

General and administrative expenses

 

(6,276)

 

(8,374)

 

(13,126)

 

(15,419)

Operating loss

 

(29,442)

 

(21,662)

 

(60,903)

 

(38,796)

Finance income / (costs) – net

 

47

 

2,253

 

(472)

 

2,724

Loss before tax

 

(29,395)

 

(19,409)

 

(61,375)

 

(36,072)

Income taxes

 

0

 

0

 

(3)

 

(2)

Loss for the period

 

(29,395)

 

(19,409)

 

(61,378)

 

(36,074)

Other comprehensive loss

 

  

 

  

 

  

 

  

Items that will not be reclassified to profit or loss

 

  

 

  

 

  

 

  

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

 

0

 

(599)

 

0

 

(6,773)

Other comprehensive loss

 

0

 

(599)

 

0

 

(6,773)

Total comprehensive loss

 

(29,395)

 

(20,008)

 

(61,378)

 

(42,847)

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

 

(0.20)

 

(0.13)

 

(0.41)

 

(0.27)

Weighted number of common shares outstanding

 

149,339,335

 

147,326,291

 

149,339,335

 

135,385,254


Affimed N.V.

Consolidated interim statements of financial position

(in € thousand)

    

June 30, 2023

    

(unaudited)

December 31, 2022

ASSETS

 

  

 

  

Non-current assets

 

  

 

  

Intangible assets

 

46

 

58

Leasehold improvements and equipment

 

3,518

 

3,823

Right-of-use assets

 

311

 

561

 

3,875

 

4,442

Current assets

 

  

 

  

Cash and cash equivalents

 

120,056

 

190,286

Trade and other receivables

 

2,154

 

2,697

Inventories

 

694

 

628

Other assets and prepaid expenses

 

7,932

 

2,459

 

130,836

 

196,070

TOTAL ASSETS

 

134,711

 

200,512

EQUITY AND LIABILITIES

 

  

 

  

Equity

 

  

 

  

Issued capital

 

1,493

 

1,493

Capital reserves

 

590,232

 

582,843

Fair value reserves

 

(1,231)

 

(1,231)

Accumulated deficit

 

(491,568)

 

(430,190)

Total equity

 

98,926

 

152,915

Non current liabilities

 

  

 

  

Borrowings

 

9,000

 

11,687

Contract liabilities

 

774

 

1,083

Lease liabilities

 

123

 

176

Total non-current liabilities

 

9,897

 

12,946

Current liabilities

 

  

 

  

Trade and other payables

 

15,810

 

19,077

Borrowings

 

5,923

 

5,930

Lease liabilities

 

200

 

396

Contract liabilities

 

3,955

 

9,248

Total current liabilities

 

25,888

 

34,651

TOTAL EQUITY AND LIABILITIES

 

134,711

 

200,512


Affimed N.V.

Unaudited consolidated interim statements of cash flows

(in € thousand)

For the six months ended

June 30

    

2023

    

2022

Cash flow from operating activities

  

  

Loss for the period

 

(61,378)

 

(36,074)

Adjustments for the period:

 

  

 

  

- Income taxes

 

3

 

2

- Depreciation and amortization

 

577

 

703

- Share-based payments

 

7,389

 

9,872

- Finance income / (costs) – net

 

472

 

(2,724)

 

(52,937)

 

(28,221)

Change in trade and other receivables

 

543

 

(715)

Change in inventories

 

(66)

 

(150)

Change in other assets and prepaid expenses

 

(5,473)

 

(3,873)

Change in trade, other payables, provisions and contract liabilities

 

(8,867)

 

(21,372)

(66,800)

(54,331)

Interest received

 

924

 

82

Paid interest

 

(695)

 

(653)

Paid income tax

(3)

(2)

Net cash used in operating activities

 

(66,574)

 

(54,904)

Cash flow from investing activities

 

  

 

  

Purchase of leasehold improvements and equipment

 

(11)

 

(194)

Cash received from the sale of financial assets

 

0

 

1,518

Net cash used for investing activities

 

(11)

 

1,324

Cash flow from financing activities

 

  

 

  

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

 

0

 

95,907

Transaction costs related to issue of common shares

 

0

 

(5,894)

Repayment of lease liabilities

 

(249)

 

(352)

Repayment of borrowings

 

(2,965)

 

(47)

Net cash used for financing activities

 

(3,214)

 

89,614

Exchange rate related changes of cash and cash equivalents

 

(431)

 

3,568

Net changes to cash and cash equivalents

 

(69,799)

 

36,034

Cash and cash equivalents at the beginning of the period

 

190,286

 

197,630

Cash and cash equivalents at the end of the period

 

120,056

 

237,232


Affimed N.V.

Unaudited consolidated interim statements of changes in equity

(in € thousand)

    

Issued

    

Capital

    

Fair Value

    

Accumulated

    

Total

capital

reserves

reserves

deficit

equity

Balance as of January 1, 2022

 

1,234

 

474,087

 

(5,973)

 

(333,397)

 

135,951

Issue of common shares

 

259

 

89,484

 

  

 

  

 

89,743

Exercise of share-based payment awards

 

101

 

  

 

  

 

101

Equity-settled share-based payment awards

9,872

9,872

Transfer of cumulative loss on sale of financial assets

  

 

2,819

(2,819)

0

Loss for the period

 

 

 

(36,074)

 

(36,074)

Other comprehensive loss

 

  

 

  

 

(6,773)

 

  

 

(6,773)

Balance as of June 30, 2022

 

1,493

 

573,544

 

(9,927)

 

(372,290)

 

192,820

Balance as of January 1, 2023

 

1,493

 

582,843

 

(1,231)

 

(430,190)

 

152,915

Equity-settled share-based payment awards

 

  

 

7,389

 

  

 

  

 

7,389

Loss for the period

(61,378)

(61,378)

Balance as of June 30, 2023

 

1,493

 

590,232

 

(1,231)

 

(491,568)

 

98,926


v3.23.2
Document and Entity Information
6 Months Ended
Jun. 30, 2023
Document Information [Line Items]  
Document Type 6-K
Document Period End Date Jun. 30, 2023
Entity File Number 001-36619
Entity Registrant Name Affimed N.V.
Entity Central Index Key 0001608390
Amendment Flag false
Current Fiscal Year End Date --12-31
Document Fiscal Year Focus 2023
Document Fiscal Period Focus Q2
v3.23.2
Unaudited consolidated interim statements of comprehensive loss - EUR (€)
€ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Unaudited consolidated interim statements of comprehensive loss        
Revenue € 1,390 € 7,301 € 5,900 € 15,307
Other income - net 717 240 1,127 524
Research and development expenses (25,273) (20,829) (54,804) (39,208)
General and administrative expenses (6,276) (8,374) (13,126) (15,419)
Operating loss (29,442) (21,662) (60,903) (38,796)
Finance income / (costs) - net 47 2,253 (472) 2,724
Loss before tax (29,395) (19,409) (61,375) (36,072)
Income taxes 0 0 (3) (2)
Loss for the period (29,395) (19,409) (61,378) (36,074)
Items that will not be reclassified to profit or loss        
Equity investments at fair value OCI - net change in fair value 0 (599) 0 (6,773)
Other comprehensive loss 0 (599) 0 (6,773)
Total comprehensive loss € (29,395) € (20,008) € (61,378) € (42,847)
Basic loss per share in € per share € (0.20) € (0.13) € (0.41) € (0.27)
Diluted loss per share in € per share € (0.20) € (0.13) € (0.41) € (0.27)
Weighted number of common shares outstanding 149,339,335 147,326,291 149,339,335 135,385,254
v3.23.2
Consolidated interim statements of financial position - EUR (€)
€ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Non-current assets    
Intangible assets € 46 € 58
Leasehold improvements and equipment 3,518 3,823
Right-of-use assets 311 561
Total non-current assets 3,875 4,442
Current assets    
Cash and cash equivalents 120,056 190,286
Trade and other receivables 2,154 2,697
Inventories 694 628
Other assets and prepaid expenses 7,932 2,459
Total current assets 130,836 196,070
TOTAL ASSETS 134,711 200,512
Equity    
Issued capital 1,493 1,493
Capital reserves 590,232 582,843
Fair value reserves (1,231) (1,231)
Accumulated deficit (491,568) (430,190)
Total equity 98,926 152,915
Non current liabilities    
Borrowings 9,000 11,687
Contract liabilities 774 1,083
Lease liabilities 123 176
Total non-current liabilities 9,897 12,946
Current liabilities    
Trade and other payables 15,810 19,077
Borrowings 5,923 5,930
Lease liabilities 200 396
Contract liabilities 3,955 9,248
Total current liabilities 25,888 34,651
TOTAL EQUITY AND LIABILITIES € 134,711 € 200,512
v3.23.2
Unaudited consolidated interim statements of cash flows - EUR (€)
€ in Thousands
6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Cash flow from operating activities    
Loss for the period € (61,378) € (36,074)
Adjustments for the period:    
Income taxes 3 2
Depreciation and amortization 577 703
Share-based payments 7,389 9,872
Finance income / (costs) - net 472 (2,724)
Total (52,937) (28,221)
Change in trade and other receivables 543 (715)
Change in inventories (66) (150)
Change in other assets and prepaid expenses (5,473) (3,873)
Change in trade, other payables, provisions and contract liabilities (8,867) (21,372)
Sub-total (66,800) (54,331)
Interest received 924 82
Paid interest (695) (653)
Paid income tax (3) (2)
Net cash used in operating activities (66,574) (54,904)
Cash flow from investing activities    
Purchase of leasehold improvements and equipment (11) (194)
Cash received from the sale of financial assets 0 1,518
Net cash used for investing activities (11) 1,324
Cash flow from financing activities    
Proceeds from issue of common shares, including exercise of share-based payment awards 0 95,907
Transaction costs related to issue of common shares 0 (5,894)
Repayment of lease liabilities (249) (352)
Repayment of borrowings (2,965) (47)
Net cash used for financing activities (3,214) 89,614
Exchange rate related changes of cash and cash equivalents (431) 3,568
Net changes to cash and cash equivalents (69,799) 36,034
Cash and cash equivalents at the beginning of the period 190,286 197,630
Cash and cash equivalents at the end of the period € 120,056 € 237,232
v3.23.2
Unaudited consolidated interim statements of changes in equity - EUR (€)
€ in Thousands
Issued capital
Capital reserves
Fair value reserves
Accumulated deficit
Total
Balance beginning at Dec. 31, 2021 € 1,234 € 474,087 € (5,973) € (333,397) € 135,951
Issue of common shares 259 89,484     89,743
Exercise of share-based payment awards   101     101
Equity-settled share-based payment awards   9,872     9,872
Transfer of cumulative loss on sale of financial assets     2,819 (2,819) 0
Loss for the period       (36,074) (36,074)
Other comprehensive loss     (6,773)   (6,773)
Balance ending at Jun. 30, 2022 1,493 573,544 (9,927) (372,290) 192,820
Balance beginning at Dec. 31, 2022 1,493 582,843 (1,231) (430,190) 152,915
Equity-settled share-based payment awards   7,389     7,389
Loss for the period       (61,378) (61,378)
Other comprehensive loss         0
Balance ending at Jun. 30, 2023 € 1,493 € 590,232 € (1,231) € (491,568) € 98,926
v3.23.2
Reporting entity
6 Months Ended
Jun. 30, 2023
Reporting entity  
Reporting entity

1.     Reporting entity

Affimed N.V. is a Dutch company with limited liability (naamloze vennootschap) and has its corporate seat in Amsterdam, the Netherlands, registered with the trade register of the Chamber of Commerce (handelsregister van de Kamer van Koophandel) under number 60673389.

The condensed consolidated interim 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, and Affimed Inc., Delaware, USA (collectively “Affimed”, the “Company” or the “Group”).

Affimed is a clinical-stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies. The Group’s product candidates are developed in the field of immuno-oncology, which represents 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, where the Group is performing research services for third parties.

v3.23.2
Basis of preparation and changes to Group's accounting policies
6 Months Ended
Jun. 30, 2023
Basis of preparation and changes to Group's accounting policies  
Basis of preparation and changes to Group's accounting policies

2.     Basis of preparation and changes to Group’s accounting policies

Statement of compliance

The condensed consolidated interim financial statements (referred to as the “interim financial statements”) as of June 30, 2023 and December 31, 2022 and for the three and six months ended June 30, 2023 and 2022 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 consolidated annual financial statements and should be read in conjunction with Affimed N.V.’s annual consolidated financial statements as of December 31, 2022.

The interim financial statements were authorized for issuance by the Company’s Management Board on August 10, 2023.

Loss per share

Loss per common share is calculated by dividing the loss for the period by the weighted average number of common shares outstanding during the period.  

As of June 30, 2023, the Group has granted 25,885,194 options and warrants in connection with share-based payment programs (see note 10) and a loan agreement, which could potentially have a dilutive effect but were excluded from the diluted weighted average number of ordinary shares calculation because their effect would have been anti-dilutive due to the net loss generated by the Group.

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 Group’s accounting policies were the same as those that applied to the consolidated financial statements as of and for the year ended December 31, 2022.

Functional and presentation currency

These interim financial statements are presented in euro. The functional currency of the Group’s subsidiaries is also the euro. 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 Group in these interim financial statements are the same as those applied by the Group in its consolidated financial statements as of and for the year ended December 31, 2022.

New standards and amendments to standards

The following forthcoming standards and amendments to standards have not been applied  in preparing these interim financial statements.

Standard/interpretation

    

Effective Date1

Amendments to IAS 1 Presentation of Financial Statements:

Classification of Liabilities as Current or Non-current

January 1, 2024

Amendments to IAS 1 Presentation of Financial Statements:

Non-current Liabilities with Covenants

January 1, 2024

Amendments to IFRS 16 Leases:

Lease Liability in a Sale and Leaseback

January 1, 2024

Amendments to IAS 7 Statement of Cash Flows and IFRS 7 Financial Instruments:

Disclosures: Supplier Finance Arrangements

January 1, 2024

The amended standards are not expected to have a significant effect on the interim financial statements of the Group.

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; and
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.

The carrying amount of all trade and other receivables, other assets and prepaid expenses, cash and cash equivalents, trade and other payables and loans 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 preferred and common shares in other companies held by the group is based on level 1 and 3 inputs (see note 5). The Group recognizes transfers between levels of the fair value hierarchy as the date at which the change has occurred.

1 Shall apply for periods beginning on or after the date shown in the effective date column.

v3.23.2
Revenue
6 Months Ended
Jun. 30, 2023
Revenue  
Revenue

3.     Revenue

Collaboration with Genentech Inc.

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

The Group recognized €0.2 million and €0.3 million as revenue during the three and six months ended June 30, 2023 (2022: €3.3 million and €7.3 million). As of the end of 2022, Affimed had completed work on and/or handed over all product candidates for further investigation by Genentech. The remaining revenue recognized during the six months ended June 30, 2023 relates to a platform license. As of June 30, 2023, the Group held contract liabilities of €1.4 million (December 31, 2022: €1.7 million), which 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.

Collaboration with Roivant Sciences Ltd.

On November 9, 2020, Affimed and Affivant Sciences GmbH (formerly Pharmavant 6 GmbH), a subsidiary of Roivant Sciences Ltd. (Roivant), announced a strategic collaboration agreement which grants Roivant a license to the preclinical molecule AFM32. Under the terms of the agreement, Affimed received $60 million in upfront consideration, comprised of $40 million in cash and pre-funded research and development funding, and $20 million of common shares in Roivant. The Group is eligible to receive up to an additional $2 billion in milestone payments upon achievement of specified development, regulatory and commercial milestones, as well as tiered royalties on net sales.

The Group recognized €1.1 million and €5.4 million as revenue during the three and six months ended June 30, 2023 (2022: €4.0 million and €7.9 million). As of June 30, 2023, the Group held contract liabilities of €3.3 million (December 31, 2022: €8.6 million), which will be recognized as revenue in subsequent periods as services are provided.

Contract balances

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

    

June 30, 2023

    

December 31, 2022

Receivables

 

10

 

0

Contract liabilities

 

4,729

 

10,331

An amount of  €1.2 million and €5.7 million included in contract liabilities at the beginning of the period has been recognized as revenue during the three and six months ended June 30, 2023.

The remaining performance obligations as of June 30, 2023 are approximately €4.7 million and are expected to be largely recognized as revenue over the next 12 months (€4.0 million), with a smaller portion being realized thereafter (€0.8 million).

Disaggregation of revenue

Three months

Three months

Six months

Six months

ended

ended

ended

ended

    

June 30, 2023

    

June 30, 2022

    

June 30, 2023

    

June 30, 2022

Geographic information

Revenue:

 

  

 

  

 

  

 

  

Germany

 

0

 

14

 

0

 

151

USA

 

1,390

 

7,287

 

5,900

 

15,156

1,390

 

7,301

 

5,900

 

15,307

Major service lines:

 

 

Collaboration revenue

 

1,215

 

7,284

 

5,671

 

15,153

Service revenue

 

175

 

17

 

229

 

154

 

1,390

 

7,301

 

5,900

 

15,307

Timing on revenue recognition:

Point in time

 

0

 

0

 

0

 

0

Over time

 

1,390

 

7,301

 

5,900

 

15,307

 

1,390

 

7,301

 

5,900

 

15,307

v3.23.2
Operating loss
6 Months Ended
Jun. 30, 2023
Operating loss  
Operating loss

4.      Operating loss

In April 2023, Affimed conducted a reorganization of its operations to focus on the Group’s three clinical stage development programs. As a result of the reorganization, the Group incurred a one-time expenditure for termination payments of €1.1 million during the three and six months ended June 30, 2023. Certain of these termination payments have already been settled and the balance will be settled in the second half of 2023. However, all of these termination payments have already been accrued for in calculating operating loss for the three and six months ended June 30,2023.

v3.23.2
Finance income and finance costs
6 Months Ended
Jun. 30, 2023
Finance income and finance costs  
Finance income and finance costs

5.     Finance income and finance costs

Three months ended

  

Three months ended

  

Six months ended

  

Six months ended

    

June 30, 2023

    

June 30, 2022

    

June 30, 2023

    

June 30, 2022

Interest SVB Loan Agreement

 

(470)

 

(381)

 

(947)

 

(759)

Foreign exchange differences

 

121

 

2,653

 

(431)

 

3,568

Other finance income/finance costs - net

 

396

 

(19)

 

906

 

(85)

47

2,253

(472)

2,724

v3.23.2
Long-term financial assets
6 Months Ended
Jun. 30, 2023
Long-term financial assets  
Long-term financial assets

6.     Long- term financial assets

The Group holds preferred shares in Amphivena, which are currently recognized at their fair value of nil. The impairment of the asset was recognized in 2021 based on the decision made by the board of Amphivena to wind down the company. Based on current information, we continue to estimate that the fair value remains at nil (December 31, 2022: nil).

v3.23.2
Trade and other receivables
6 Months Ended
Jun. 30, 2023
Trade and other receivables  
Trade and other receivables

7.     Trade and other receivables

The trade receivables as of June 30, 2023 were €10 (December 31, 2022: €0). These trade receivables are all due in the short-term, do not bear interest and are not impaired. Other receivables are all due within the short-term and mainly comprise value-added tax receivables of €0.9 million (December 31, 2022: €1.5 million).

v3.23.2
Other assets and prepaid expenses
6 Months Ended
Jun. 30, 2023
Other assets and prepaid expenses  
Other assets and prepaid expenses

8.     Other assets and prepaid expenses

The other assets and prepaid expenses as of June 30, 2023 of €7.9 million (December 31, 2022: €2.5 million) are short-term in nature, do not bear interest and are not impaired. The other assets and prepaid expenses mainly comprise a prepayment of €3.2 million for clinical trial management services and €0.7 million for reservation for toxicity study capacity (December 31, 2022: €1.1 million for the reservation of manufacturing capacity), a directors and officers’ liability insurance premium of €1.2 million (December 31, 2022: €0 million) and €1.5 million (December 31, 2022: €0.5 million) prepayment for assets secured for new premises.

v3.23.2
Equity
6 Months Ended
Jun. 30, 2023
Equity  
Equity

9.     Equity

As of June 30, 2023, the share capital of €1,493 (December 31, 2022: €1,493) is comprised of 149,339,335 (December 31, 2022: 149,339,335) common shares with a par value of €0.01 per share.

On April 18, 2022, the Company closed its public offering of 25,875,000 common shares (including over-allotment shares) at the public offering price of $4.00 per share, generating net proceeds of €89.8 million ($97.1 million), after deducting €6.0 million ($6.5 million) in underwriting commissions and other offering expenses.

v3.23.2
Share-based payments
6 Months Ended
Jun. 30, 2023
Share-based payments  
Share-based payments

10.     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, certain members of the Company’s Supervisory Board, non-employee consultants and employees.

Share-based payments with service conditions

The majority of the awards vest in instalments over three years and can be exercised up to 10 years after the grant date. The Group granted 384,000 and 8,052,750 awards for the three and six months ended June 30, 2023 to employees, members of the Management Board and members of the Supervisory Board. Fair value of the awards at grant date in the three and six months ended June 30, 2023 amounts to €0.2 million ($0.2 million) and €5.9 million ($6.3 million). 217,725 and 368,540 ESOP 2014 awards were cancelled or forfeited due to termination of employment during the three and six months ended June 30, 2023 (June 30, 2022: 13,926 and 99,591). During the three and six months ended June 30, 2023, no options were exercised (June 30, 2022: 18,994 and 43,440 options at a weighted average share price of $2.26 and $2.52).

As of June 30, 2023, 22,953,944 ESOP 2014 options were outstanding (December 31, 2022: 15,269,734), and 11,169,133 awards had vested (December 31, 2022: 8,510,863). The options outstanding as of June 30, 2023 had an exercise price in the range of $0.60 to $13.47 and a weighted average remaining contractual life of 7.7 years (December 31, 2022: 7.4 years) and a weighted average exercise price of $3.55 (December 31, 2022: $4.91).

Share-based payments with market condition

During 2022, the Company issued 2,825,000 options (1,325,000 awards in the first quarter and 1,500,000 awards in the second quarter of 2022), with market-based performance conditions to members of the Management Board and employees. Each grant consists of three tranches, whereby one-third of the total grant will vest when the volume-weighted average share price over the preceding thirty trading days reaches $12.00, $15.00, and $18.00, respectively. Except with respect to a change of control, these options shall not vest before the first anniversary of the grant date. As of June 30, 2023, no options were cancelled, forfeited or exercised.

Fair value at grant date of the awards granted in the three and six months ended June 30, 2022 amounts to €1.4 million ($1.8 million) and €2.9 million ($3.2 million). The contractual lifetime of the options is two years. Any unvested awards on the date that is two years following the grant date will lapse.

Share-based payment expense

In the three and six months ended June 30, 2023, compensation expense of €3,231 (including an accelerated expense due to the reduction of the Company’s headcount in the course of the reorganization) and €7,389 was recognized affecting research and development expenses (€1,709 and €4,022) and general and administrative expenses (€1,523 and €3,368). In the three and six months ended June 30, 2022, compensation expense of €5,625 and €9,872 was recognized affecting research and development expenses (€2,889 and €5,194) and general and administrative expenses (€2,736 and €4,678).

Fair value measurement

The fair value of options with service conditions granted in the six months ended June 30, 2023 and 2022, respectively, was determined using the Black-Scholes-Merton valuation model. The significant inputs into the valuation model are as follows (weighted average):

    

June 30, 2023

    

June 30, 2022

Fair value at grant date

$

0.79

$

3.30

Share price at grant date

$

1.05

$

4.45

Exercise price

$

1.05

$

4.45

Expected volatility

 

90

%

 

90

%

Expected life

 

5.86

 

5.87

Expected dividends

 

0.00

 

0.00

Risk-free interest rate

 

3.95

%

 

2.22

%

The fair value of options with market conditions granted in the six months ended June 30, 2022, was determined using a Monte Carlo simulation. The significant inputs into the valuation model are as follows (weighted average):

    

June 30, 2022

 

Fair value at grant date

$

1.13

Share price at grant date

$

4.58

Exercise price

$

4.58

Expected volatility

 

70

%

Expected life

 

2.00

Expected dividends

 

0.00

Risk-free interest rate

 

2.41

%

Expected volatility is estimated based on the observed daily share price returns of Affimed 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 (as best available indication for risk-free rates), for a term equal to the expected life, as measured as of the grant date.

v3.23.2
Borrowings
6 Months Ended
Jun. 30, 2023
Borrowings  
Borrowings

11.     Borrowings

Silicon Valley Bank

In January 2021, the Group entered into a new loan agreement with Silicon Valley Bank German Branch (now: Silicon Valley Bridge Bank N.A. Germany Branch) or “SVB” which provides Affimed with up to €25 million in term loans in three tranches: €10 million available at closing, an additional €7.5 million upon the achievement of certain conditions, including milestones related to Affimed’s pipeline and market capitalization, and a third tranche of €7.5 million upon the achievement of certain additional conditions related to Affimed’s pipeline and liquidity. The first tranche of €10 million was drawn in February 2021 and the second tranche of €7.5 million in December 2021. Pursuant to the terms of the agreement, the loan bears interest at the greater of the European Central Bank Base Rate and 0%, plus 5.5%. Affimed was entitled to make interest only payments through December 1, 2022. The loan will mature at the end of November 2025. As of June 30, 2023, the fair value of the liability did not differ significantly from its carrying amount.

The loan is secured by a pledge of 100% of the Group’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 interim financial statements.

In July 2023, Bootstrap Europe announced the acquisition of SVB. The loan agreement is expected to be transferred to Bootstrap Europe with no change in the terms of the loan agreement.

UniCredit Leasing CZ

In April 2019, the Group entered into a loan agreement with UniCredit Leasing CZ for €562. After an initial instalment of €127 in the second quarter of 2019, repayment is effected in monthly instalments of €8 until May 2024. As of June 30, 2023, an amount of €89 (December 31, 2022: €136) was outstanding, of which  €89 was classified as current liabilities (December 31, 2022: €96). As of June 30, 2023, the fair value of the liability did not differ significantly from its carrying amount.

v3.23.2
Related parties
6 Months Ended
Jun. 30, 2023
Related parties  
Related parties

12.     Related parties

The supervisory board directors of Affimed N.V. received compensation in the amounts of €114 and €238 (€107 and €216) for their services on the Supervisory Board in the three and six months ended June 30, 2023 (2022). Members of the Management Board received compensation in the amounts of €972 and €1,916 (€936 and €1,829) for their services on the Management Board in the three and six months ended June 30, 2023 (2022).

The Company recognized share-based payment expenses of €83 and €195 (€719 and €998) for supervisory directors and €1,317 and €2,954 (€1,816 and €3,389) for managing directors in the three and six months ended June 30, 2023 (2022).

The following table provides the total amounts of outstanding balances for supervisory board compensation and expense reimbursement related to key management personnel:

Outstanding balances

June 30, 

December 31, 

    

2023

    

2022

Adi Hoess

 

-

 

1

Wolfgang Fischer

-

2

Arndt Schottelius

-

3

Thomas Hecht

 

20

 

21

Mathieu Simon

 

9

 

10

Ulrich Grau

 

22

 

26

Bernhard Ehmer

12

17

Harry Welten

9

8

Annalisa Jenkins

11

11

Uta Kemmerich-Keil

 

17

 

18

Constanze Ulmer-Eilfort

5

-

v3.23.2
Basis of preparation and changes to Group's accounting policies (Policies)
6 Months Ended
Jun. 30, 2023
Basis of preparation and changes to Group's accounting policies  
Statement of compliance

Statement of compliance

The condensed consolidated interim financial statements (referred to as the “interim financial statements”) as of June 30, 2023 and December 31, 2022 and for the three and six months ended June 30, 2023 and 2022 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 consolidated annual financial statements and should be read in conjunction with Affimed N.V.’s annual consolidated financial statements as of December 31, 2022.

The interim financial statements were authorized for issuance by the Company’s Management Board on August 10, 2023.

Loss per share

Loss per share

Loss per common share is calculated by dividing the loss for the period by the weighted average number of common shares outstanding during the period.  

As of June 30, 2023, the Group has granted 25,885,194 options and warrants in connection with share-based payment programs (see note 10) and a loan agreement, which could potentially have a dilutive effect but were excluded from the diluted weighted average number of ordinary shares calculation because their effect would have been anti-dilutive due to the net loss generated by the Group.

Critical judgments and accounting estimates

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 Group’s accounting policies were the same as those that applied to the consolidated financial statements as of and for the year ended December 31, 2022.

Functional and presentation currency

Functional and presentation currency

These interim financial statements are presented in euro. The functional currency of the Group’s subsidiaries is also the euro. All financial information presented in euro has been rounded to the nearest thousand (abbreviated €) or million (abbreviated € million).

Significant accounting policies

Significant accounting policies

The accounting policies applied by the Group in these interim financial statements are the same as those applied by the Group in its consolidated financial statements as of and for the year ended December 31, 2022.

New standards and amendments to standards

New standards and amendments to standards

The following forthcoming standards and amendments to standards have not been applied  in preparing these interim financial statements.

Standard/interpretation

    

Effective Date1

Amendments to IAS 1 Presentation of Financial Statements:

Classification of Liabilities as Current or Non-current

January 1, 2024

Amendments to IAS 1 Presentation of Financial Statements:

Non-current Liabilities with Covenants

January 1, 2024

Amendments to IFRS 16 Leases:

Lease Liability in a Sale and Leaseback

January 1, 2024

Amendments to IAS 7 Statement of Cash Flows and IFRS 7 Financial Instruments:

Disclosures: Supplier Finance Arrangements

January 1, 2024

The amended standards are not expected to have a significant effect on the interim financial statements of the Group.

Fair Value Measurement

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; and
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.

The carrying amount of all trade and other receivables, other assets and prepaid expenses, cash and cash equivalents, trade and other payables and loans 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 preferred and common shares in other companies held by the group is based on level 1 and 3 inputs (see note 5). The Group recognizes transfers between levels of the fair value hierarchy as the date at which the change has occurred.

1 Shall apply for periods beginning on or after the date shown in the effective date column.

v3.23.2
Basis of preparation and changes to Group's accounting policies (Tables)
6 Months Ended
Jun. 30, 2023
Basis of preparation and changes to Group's accounting policies  
Schedule of new standards and amendments to standards

Standard/interpretation

    

Effective Date1

Amendments to IAS 1 Presentation of Financial Statements:

Classification of Liabilities as Current or Non-current

January 1, 2024

Amendments to IAS 1 Presentation of Financial Statements:

Non-current Liabilities with Covenants

January 1, 2024

Amendments to IFRS 16 Leases:

Lease Liability in a Sale and Leaseback

January 1, 2024

Amendments to IAS 7 Statement of Cash Flows and IFRS 7 Financial Instruments:

Disclosures: Supplier Finance Arrangements

January 1, 2024

v3.23.2
Revenue (Tables)
6 Months Ended
Jun. 30, 2023
Revenue  
Schedule of receivables and contract liabilities from contracts with customers

    

June 30, 2023

    

December 31, 2022

Receivables

 

10

 

0

Contract liabilities

 

4,729

 

10,331

Schedule of disaggregation of revenue

Three months

Three months

Six months

Six months

ended

ended

ended

ended

    

June 30, 2023

    

June 30, 2022

    

June 30, 2023

    

June 30, 2022

Geographic information

Revenue:

 

  

 

  

 

  

 

  

Germany

 

0

 

14

 

0

 

151

USA

 

1,390

 

7,287

 

5,900

 

15,156

1,390

 

7,301

 

5,900

 

15,307

Major service lines:

 

 

Collaboration revenue

 

1,215

 

7,284

 

5,671

 

15,153

Service revenue

 

175

 

17

 

229

 

154

 

1,390

 

7,301

 

5,900

 

15,307

Timing on revenue recognition:

Point in time

 

0

 

0

 

0

 

0

Over time

 

1,390

 

7,301

 

5,900

 

15,307

 

1,390

 

7,301

 

5,900

 

15,307

v3.23.2
Finance income and finance costs (Tables)
6 Months Ended
Jun. 30, 2023
Finance income and finance costs  
Schedule of finance income and finance costs

Three months ended

  

Three months ended

  

Six months ended

  

Six months ended

    

June 30, 2023

    

June 30, 2022

    

June 30, 2023

    

June 30, 2022

Interest SVB Loan Agreement

 

(470)

 

(381)

 

(947)

 

(759)

Foreign exchange differences

 

121

 

2,653

 

(431)

 

3,568

Other finance income/finance costs - net

 

396

 

(19)

 

906

 

(85)

47

2,253

(472)

2,724

v3.23.2
Share-based payments (Tables)
6 Months Ended
Jun. 30, 2023
Share-based payments with service condition  
Share-based payments  
Schedule of fair value of options

    

June 30, 2023

    

June 30, 2022

Fair value at grant date

$

0.79

$

3.30

Share price at grant date

$

1.05

$

4.45

Exercise price

$

1.05

$

4.45

Expected volatility

 

90

%

 

90

%

Expected life

 

5.86

 

5.87

Expected dividends

 

0.00

 

0.00

Risk-free interest rate

 

3.95

%

 

2.22

%

Share-based payments with market condition  
Share-based payments  
Schedule of fair value of options

    

June 30, 2022

 

Fair value at grant date

$

1.13

Share price at grant date

$

4.58

Exercise price

$

4.58

Expected volatility

 

70

%

Expected life

 

2.00

Expected dividends

 

0.00

Risk-free interest rate

 

2.41

%

v3.23.2
Related parties (Tables)
6 Months Ended
Jun. 30, 2022
Related parties  
Outstanding balances for supervisory board compensation and expense reimbursement related to key management personnel

Outstanding balances

June 30, 

December 31, 

    

2023

    

2022

Adi Hoess

 

-

 

1

Wolfgang Fischer

-

2

Arndt Schottelius

-

3

Thomas Hecht

 

20

 

21

Mathieu Simon

 

9

 

10

Ulrich Grau

 

22

 

26

Bernhard Ehmer

12

17

Harry Welten

9

8

Annalisa Jenkins

11

11

Uta Kemmerich-Keil

 

17

 

18

Constanze Ulmer-Eilfort

5

-

v3.23.2
Basis of preparation and changes to Group's accounting policies (Details)
6 Months Ended
Jun. 30, 2023
shares
Basis of preparation and changes to Group's accounting policies  
Number of shares excluded from calculation of earnings per share because their effect would have been anti-dilutive 25,885,194
v3.23.2
Basis of preparation and changes to Group's accounting policies - New standards and amendments to standards (Details)
6 Months Ended
Jun. 30, 2023
Amendments to IAS 1 Presentation of Financial Statements: Classification of Liabilities as Current or Non-current  
Basis of preparation and changes to Group's accounting policies  
Standard/interpretation Classification of Liabilities as Current or Non-current
Effective Date Jan. 01, 2024
Amendments to IAS 1 Presentation of Financial Statements: Non-current Liabilities with Covenants  
Basis of preparation and changes to Group's accounting policies  
Standard/interpretation Non-current Liabilities with Covenants
Effective Date Jan. 01, 2024
Amendments to IFRS 16 Leases: Lease Liability in a Sale and Leaseback  
Basis of preparation and changes to Group's accounting policies  
Standard/interpretation Lease Liability in a Sale and Leaseback
Effective Date Jan. 01, 2024
Amendments to IAS 7 Statement of Cash Flows and IFRS 7 Financial Instruments, Disclosures: Supplier Finance Arrangements  
Basis of preparation and changes to Group's accounting policies  
Standard/interpretation Disclosures: Supplier Finance Arrangements
Effective Date Jan. 01, 2024
v3.23.2
Revenue - Additional Information (Details)
€ in Millions, $ in Millions
1 Months Ended 3 Months Ended 6 Months Ended 12 Months Ended
Nov. 09, 2020
USD ($)
Oct. 31, 2018
USD ($)
Oct. 31, 2018
EUR (€)
Jun. 30, 2023
EUR (€)
Jun. 30, 2022
EUR (€)
Jun. 30, 2023
EUR (€)
Jun. 30, 2022
EUR (€)
Dec. 31, 2022
EUR (€)
Jun. 30, 2023
USD ($)
Jun. 30, 2023
EUR (€)
Disclosure of disaggregation of revenue from contracts with customers [line items]                    
Revenue under contract liabilities       € 1.2   € 5.7        
Remaining performance obligations                   € 4.7
Remaining performance obligation period           12 months        
Performance obligations description           The remaining performance obligations as of June 30, 2023 are approximately €4.7 million and are expected to be largely recognized as revenue over the next 12 months (€4.0 million), with a smaller portion being realized thereafter (€0.8 million).        
Over the next 12 months                    
Disclosure of disaggregation of revenue from contracts with customers [line items]                    
Remaining performance obligations                   4.0
12 months thereafter                    
Disclosure of disaggregation of revenue from contracts with customers [line items]                    
Remaining performance obligations                   € 0.8
Genentech Inc                    
Disclosure of disaggregation of revenue from contracts with customers [line items]                    
Collaboration agreement initial upfront consideration   $ 96.0 € 83.2              
Revenue       0.2 € 3.3 € 0.3 € 7.3      
Revenue under contract liabilities           1.4   € 1.7    
Additional payments upon achievement of milestones | $                 $ 5,000.0  
Roivant Sciences Ltd.                    
Disclosure of disaggregation of revenue from contracts with customers [line items]                    
Collaboration agreement initial upfront consideration | $ $ 60.0                  
Revenue       € 1.1 € 4.0 5.4 € 7.9      
Revenue under contract liabilities           € 3.3   € 8.6    
Additional payments upon achievement of milestones | $ 2,000.0                  
Collaboration agreement cash consideration | $ 40.0                  
Collaboration agreement consideration in shares | $ $ 20.0                  
v3.23.2
Revenue (Details) - EUR (€)
€ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Revenue    
Receivables € 10 € 0
Contract liabilities € 4,729 € 10,331
v3.23.2
Revenue - Disaggregation of revenue (Details) - EUR (€)
€ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Revenue        
Revenues € 1,390 € 7,301 € 5,900 € 15,307
Germany        
Revenue        
Revenues 0 14 0 151
USA        
Revenue        
Revenues 1,390 7,287 5,900 15,156
Point in time        
Revenue        
Revenues 0 0 0 0
Over time        
Revenue        
Revenues 1,390 7,301 5,900 15,307
Collaboration        
Revenue        
Revenues 1,215 7,284 5,671 15,153
Service        
Revenue        
Revenues € 175 € 17 € 229 € 154
v3.23.2
Operating loss (Details) - EUR (€)
€ in Millions
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2023
Operating loss    
Termination payments € 1.1 € 1.1
v3.23.2
Finance income and finance costs (Details) - EUR (€)
€ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Disclosure of Finance Income and Finance Costs Line Items]        
Finance income/costs - net € 47 € 2,253 € (472) € 2,724
Interest SVB Loan Agreement        
Disclosure of Finance Income and Finance Costs Line Items]        
Finance income/costs - net (470) (381) (947) (759)
Foreign exchange differences        
Disclosure of Finance Income and Finance Costs Line Items]        
Finance income/costs - net 121 2,653 (431) 3,568
Other finance income/finance costs - net        
Disclosure of Finance Income and Finance Costs Line Items]        
Finance income/costs - net € 396 € (19) € 906 € (85)
v3.23.2
Long-term financial assets (Details) - Preferred Shares - EUR (€)
€ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Long-term financial assets    
Fair value of shares € 0  
Fair value shares of remaining € 0 € 0
v3.23.2
Trade and other receivables (Details) - EUR (€)
€ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Trade and other receivables    
Trade receivables € 10 € 0
Value added tax receivables € 900 € 1,500
v3.23.2
Other assets and prepaid expenses (Details) - EUR (€)
€ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Other assets and prepaid expenses    
Other assets and prepaid expenses € 7,932 € 2,459
Prepayment for Directors and Officers' liability insurance premium 1,200 0
Reservation of manufacturing capacity    
Other assets and prepaid expenses    
Prepayment for reservation of manufacturing capacity   1,100
Assets secured for the new premises    
Other assets and prepaid expenses    
Prepayments 1,500 € 500
Clinical trial management services    
Other assets and prepaid expenses    
Prepayment for reservation of manufacturing capacity 3,200  
Reservation for toxicity study capacity    
Other assets and prepaid expenses    
Prepayment for reservation of manufacturing capacity € 700  
v3.23.2
Equity (Details)
€ / shares in Units, $ / shares in Units, € in Thousands, $ in Millions
6 Months Ended
Apr. 18, 2022
EUR (€)
shares
Apr. 18, 2022
USD ($)
$ / shares
shares
Jun. 30, 2023
EUR (€)
€ / shares
shares
Jun. 30, 2022
EUR (€)
Dec. 31, 2022
EUR (€)
€ / shares
shares
Issued capital | €     € 1,493   € 1,493
Number of shares outstanding | shares     149,339,335   149,339,335
Par value | € / shares     € 0.01   € 0.01
Net proceeds from issue of common shares | €     € 0 € 95,907  
Public offering          
Number of shares issued | shares 25,875,000 25,875,000      
Net proceeds from issue of common shares € 89,800 $ 97.1      
Share price | $ / shares   $ 4.00      
Underwriting commissions, legal and consulting expenses € 6,000 $ 6.5      
v3.23.2
Share-based payments - Fair value of options (Details)
6 Months Ended
Jun. 30, 2023
USD ($)
Y
$ / shares
Jun. 30, 2022
USD ($)
Y
EUR (€)
$ / shares
Share-based payments with service condition    
Share-based payments    
Fair value at grant date | $ $ 0.79 $ 3.30
Share price at grant date | $ / shares $ 1.05 $ 4.45
Exercise price | $ / shares $ 1.05 $ 4.45
Expected volatility 90.00% 90.00%
Expected life | Y 5.86 5.87
Expected dividends | $ $ 0.00 $ 0.00
Risk-free interest rate 3.95% 2.22%
Share-based payments with market condition    
Share-based payments    
Fair value at grant date | $   $ 1.13
Share price at grant date | $ / shares   $ 4.58
Exercise price | $ / shares   $ 4.58
Expected volatility   70.00%
Expected life | €   2.00
Expected dividends | $   $ 0.00
Risk-free interest rate   2.41%
v3.23.2
Share-based payments - Service conditions (Details)
$ / shares in Units, $ in Millions
3 Months Ended 6 Months Ended 12 Months Ended
Jun. 30, 2023
EUR (€)
EquityInstruments
shares
Jun. 30, 2023
USD ($)
EquityInstruments
$ / shares
shares
Jun. 30, 2022
EquityInstruments
$ / shares
shares
Jun. 30, 2023
EUR (€)
EquityInstruments
shares
Jun. 30, 2023
USD ($)
EquityInstruments
$ / shares
shares
Jun. 30, 2022
EquityInstruments
$ / shares
shares
Dec. 31, 2022
EquityInstruments
$ / shares
Share-based payments with service condition              
Awards cancelled or forfeited | €       0      
ESOP 2014              
Share-based payments with service condition              
Vesting period (in years)       3 years 3 years    
Exercise period       10 years 10 years    
Awards granted | EquityInstruments 384,000 384,000   8,052,750 8,052,750    
Fair value of the awards at grant date € 200,000 $ 0.2   € 5,900,000 $ 6.3    
Awards cancelled or forfeited | EquityInstruments 217,725 217,725 13,926 368,540 368,540 99,591  
Awards exercised | shares 0 0 18,994 0 0 43,440  
Weighted average exercise price of awards exercised         $ 3.55   $ 4.91
Awards outstanding | EquityInstruments   22,953,944     22,953,944   15,269,734
Awards vested | EquityInstruments       11,169,133 11,169,133   8,510,863
Weighted average remaining contractual life       7 years 8 months 12 days 7 years 8 months 12 days   7 years 4 months 24 days
ESOP 2014 | Minimum              
Share-based payments with service condition              
Weighted average exercise price of awards exercised     $ 2.26        
Exercise price   $ 0.60     $ 0.60    
ESOP 2014 | Maximum              
Share-based payments with service condition              
Weighted average exercise price of awards exercised           $ 2.52  
Exercise price   $ 13.47     $ 13.47    
v3.23.2
Share-based payments - Market condition (Details)
3 Months Ended 6 Months Ended
Jun. 30, 2022
shares
Mar. 31, 2022
shares
Jun. 30, 2023
EUR (€)
tranche
$ / shares
Jun. 30, 2022
shares
Share-based payments with market condition        
Number of options issued | shares 1,500,000 1,325,000   2,825,000
Number of tranches | tranche     3  
Awards cancelled or forfeited | €     0  
Trading days     30 days  
Contractual lifetime of the options       2 years
Tranche I        
Share-based payments with market condition        
Hurdle rate     $ 12.00  
Tranche II        
Share-based payments with market condition        
Hurdle rate     15.00  
Tranche III        
Share-based payments with market condition        
Hurdle rate     $ 18.00  
v3.23.2
Share-based payments - Payment expense (Details) - EUR (€)
€ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Share-based payments        
Share-based expense € 3,231 € 5,625 € 7,389 € 9,872
Research and Development        
Share-based payments        
Share-based expense 1,709 2,889 4,022 5,194
General and Administrative        
Share-based payments        
Share-based expense € 1,523 € 2,736 € 3,368 € 4,678
v3.23.2
Share-based payments - Additional Information (Details)
$ / shares in Units, $ in Millions
3 Months Ended 6 Months Ended 12 Months Ended
Jun. 30, 2023
EUR (€)
EquityInstruments
shares
Jun. 30, 2023
USD ($)
EquityInstruments
$ / shares
shares
Jun. 30, 2022
EUR (€)
EquityInstruments
shares
Jun. 30, 2022
USD ($)
EquityInstruments
$ / shares
shares
Mar. 31, 2022
shares
Jun. 30, 2023
EUR (€)
EquityInstruments
tranche
shares
Jun. 30, 2023
USD ($)
EquityInstruments
tranche
$ / shares
shares
Jun. 30, 2022
EUR (€)
EquityInstruments
shares
Jun. 30, 2022
USD ($)
EquityInstruments
$ / shares
shares
Dec. 31, 2022
EquityInstruments
$ / shares
Share-based payments                    
Awards cancelled or forfeited | €           0        
Number of options issued | shares     1,500,000 1,500,000 1,325,000     2,825,000 2,825,000  
Number of tranches | tranche           3 3      
Trading days           30 days 30 days      
Contractual lifetime of the options               2 years 2 years  
Share-based expense | € € 3,231,000   € 5,625,000     € 7,389,000   € 9,872,000    
Vesting percentage           0.33% 0.33%      
Tranche I                    
Share-based payments                    
Hurdle rate             $ 12.00      
Tranche II                    
Share-based payments                    
Hurdle rate             15.00      
Tranche III                    
Share-based payments                    
Hurdle rate             $ 18.00      
Research and Development                    
Share-based payments                    
Share-based expense | € 1,709,000   2,889,000     € 4,022,000   5,194,000    
General and Administrative                    
Share-based payments                    
Share-based expense | € € 1,523,000   € 2,736,000     € 3,368,000   € 4,678,000    
ESOP 2014                    
Share-based payments                    
Vesting period (in years)           3 years 3 years      
Exercise period           10 years 10 years      
Awards granted | EquityInstruments 384,000 384,000       8,052,750 8,052,750      
Fair value of the awards at grant date € 200,000 $ 0.2       € 5,900,000 $ 6.3      
Awards cancelled or forfeited | EquityInstruments 217,725 217,725 13,926 13,926   368,540 368,540 99,591 99,591  
Awards exercised | shares 0 0 18,994 18,994   0 0 43,440 43,440  
Weighted average exercise price of awards exercised             $ 3.55     $ 4.91
Awards outstanding | EquityInstruments   22,953,944         22,953,944     15,269,734
Awards vested | EquityInstruments           11,169,133 11,169,133     8,510,863
Weighted average remaining contractual life           7 years 8 months 12 days 7 years 8 months 12 days     7 years 4 months 24 days
Grant date fair value     € 1,400,000 $ 1.8       € 2,900,000 $ 3.2  
ESOP 2014 | Minimum                    
Share-based payments                    
Weighted average exercise price of awards exercised       $ 2.26            
Exercise price   $ 0.60         $ 0.60      
ESOP 2014 | Maximum                    
Share-based payments                    
Weighted average exercise price of awards exercised                 $ 2.52  
Exercise price   $ 13.47         $ 13.47      
v3.23.2
Borrowings - Additional Information (Details) - EUR (€)
€ in Thousands
1 Months Ended 3 Months Ended 6 Months Ended
Dec. 31, 2021
Feb. 28, 2021
Jun. 30, 2019
Jun. 30, 2023
Dec. 31, 2022
Jan. 31, 2021
Apr. 30, 2019
Loan agreement with UniCredit Leasing CZ              
Borrowings              
Amount outstanding       € 89 € 136   € 562
Loan repaid     € 127        
Monthly repayment instalment             € 8
Current liabilities       € 89 € 96    
Silicon Valley Bank Loan              
Borrowings              
Percentage of ownership interest pledged as security       100.00%      
SVB Loan Agreement | Loan facility trance one              
Borrowings              
Term loans           € 10,000  
Amount drawdown   € 10,000          
SVB Loan Agreement | Loan facility trance two              
Borrowings              
Term loans           7,500  
Amount drawdown € 7,500            
SVB Loan Agreement | Loan facility trance three              
Borrowings              
Term loans           € 7,500  
Minimum | EURIBOR              
Borrowings              
Variable interest rate           0.00%  
Maximum              
Borrowings              
Variable interest rate           5.50%  
Maximum | SVB Loan Agreement              
Borrowings              
Term loans           € 25,000  
v3.23.2
Related parties - Outstanding Balances (Details) - EUR (€)
€ in Thousands
Jun. 30, 2023
Dec. 31, 2022
Adi Hoess    
Related parties    
Key management personnel outstanding balance   € 1
Wolfgang Fischer    
Related parties    
Key management personnel outstanding balance   2
Arndt Schottelius    
Related parties    
Key management personnel outstanding balance   3
Thomas Hecht    
Related parties    
Key management personnel outstanding balance € 20 21
Mathieu Simon    
Related parties    
Key management personnel outstanding balance 9 10
Ulrich Grau    
Related parties    
Key management personnel outstanding balance 22 26
Bernhard Ehmer    
Related parties    
Key management personnel outstanding balance 12 17
Harry Welten    
Related parties    
Key management personnel outstanding balance 9 8
Annalisa Jenkins    
Related parties    
Key management personnel outstanding balance 11 11
Uta Kemmerich-Kell    
Related parties    
Key management personnel outstanding balance 17 € 18
Constanze Ulmer-Eilfort    
Related parties    
Key management personnel outstanding balance € 5  
v3.23.2
Related parties - Additional Information (Details) - EUR (€)
€ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2023
Jun. 30, 2022
Jun. 30, 2023
Jun. 30, 2022
Related parties        
Share-based expense € 3,231 € 5,625 € 7,389 € 9,872
Supervisory Board Directors        
Related parties        
Compensation received for their services 114 107 238 216
Share-based expense 83 719 195 998
Management Board        
Related parties        
Compensation received for their services 972 936 1,916 1,829
Share-based expense € 1,317 € 1,816 € 2,954 € 3,389

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