Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16]

Share Name	Share Symbol	Market	Type
Affimed NV	NASDAQ:AFMD	NASDAQ	Common Stock

	Price Change	% Change	Share Price	Bid Price	Offer Price	High Price	Low Price	Open Price	Shares Traded	Last Trade
	0.05	4.24%	1.23	1.16	2.75	1.25	1.1438	1.21	414,367	05:00:01

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

of the Securities Exchange Act of 1934

For the month of November, 2024

Commission File Number: 001-36619

Affimed N.V.

Gottlieb-Daimler-Straße 2,

68165 Mannheim

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 333-282978), 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333-270798) of Affimed N.V. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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: November 14, 2024	By:	/s/ Shawn Leland
	Name:	Shawn Leland
	Title:	Chief Executive Officer

	By:	/s/ Denise Mueller
	Name:	Denise Mueller
	Title:	Chief Business Officer

EXHIBIT INDEX


Exhibit		Description of Exhibit

99.1		Affimed N.V. Unaudited Condensed Consolidated Interim Financial Statements as of September 30, 2024.

99.2		Affimed N.V. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

99.3		Affimed N.V. Press Release dated November 14, 2024.

Exhibit 99.1

Affimed N.V.

Unaudited consolidated interim statements of comprehensive loss

(in € thousand)


		For the three months ended September 30						For the nine months ended September 30
	Note	2024			2023			2024			2023
Revenue	3		155			1,962			464			7,862
Other income and expenses – net			9			(6	)		242			1,121
Research and development expenses			(10,136	)		(21,498	)		(37,254	)		(76,302	)
General and administrative expenses			(4,311	)		(5,381	)		(12,823	)		(18,507	)

Operating loss	4		(14,283	)		(24,923	)		(49,371	)		(85,826	)
Finance income / (costs) – net	5		(855	)		568			(390	)		96

Loss before tax			(15,138	)		(24,355	)		(49,761	)		(85,730	)
Income taxes			(1	)		0			(4	)		(3	)

Loss for the period			(15,139	)		(24,355	)		(49,765	)		(85,733	)

Total comprehensive loss			(15,139	)		(24,355	)		(49,765	)		(85,733	)

Basic and diluted loss per share in € per share (undiluted = diluted)			(0.94	)		(1.63	)		(3.20	)		(5.74	)
Weighted number of common shares outstanding			16,100,185			14,933,934			15,553,627			14,933,934

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

Affimed N.V.

Consolidated interim statements of financial position

(in € thousand)


	Note		September 30, 2024 (unaudited)			December 31, 2023
ASSETS
Non-current assets
Intangible assets				15			25
Leasehold improvements and equipment				2,246			4,905
Right-of-use assets				5,307			8,039

				7,568			12,969
Current assets
Cash and cash equivalents				7,405			38,529
Investments		6		16,695			33,518
Other financial assets		7		840			851
Trade and other receivables		8		4,543			5,327
Inventories				0			463
Other assets and prepaid expenses		9		2,908			5,500

				32,391			84,188
TOTAL ASSETS				39,959			97,157
EQUITY AND LIABILITIES
Equity
Issued capital				1,639			1,500
Capital reserves				602,680			593,666
Fair value reserves				(1,231	)		(1,231	)
Accumulated deficit				(585,893	)		(536,128	)

Total equity		10		17,195			57,807
Non current liabilities
Borrowings		12		2,231			6,319
Contract liabilities		3		0			464
Lease liabilities				3,755			6,660

Total non-current liabilities				5,986			13,443
Current liabilities
Trade and other payables				9,256			18,916
Borrowings		12		5,833			5,833
Lease liabilities				1,070			539
Contract liabilities		3		619			619

Total current liabilities				16,778			25,907
TOTAL EQUITY AND LIABILITIES				39,959			97,157

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

Affimed N.V.

Unaudited consolidated interim statements of cash flows

(in € thousand)


			For the nine months ended September 30
	Note		2024			2023
Cash flow from operating activities
Loss for the period				(49,765	)		(85,733	)
Adjustments for the period:
- Income taxes				4			3
- Depreciation and amortization				2,945			1,273
- Net (gain)/loss on disposal of leasehold improvements and equipment				(24	)		74
- Loss from write-down of inventories				456			0
- Share-based payments		11		2,133			9,238
- Finance income / (costs) – net		5		390			(96	)

				(43,861	)		(75,241	)
Change in trade and other receivables				783			251
Change in inventories				7			(181	)
Change in other assets and prepaid expenses				2,641			(3,639	)
Change in trade, other payables, provisions and contract liabilities				(10,276	)		(6,442	)

				(50,706	)		(85,252	)
Interest received				203			1,497
Paid interest				(955	)		(1,069	)
Paid income tax				(4	)		(3	)

Net cash used in operating activities				(51,462	)		(84,827	)

Cash flow from investing activities
Purchase of leasehold improvements and equipment, including upfront payments for right-of-use assets				(25	)		(3,220	)
Cash received from the sale of financial assets				17,529			0
Cash paid for investments in financial assets				0			(34,246	)
Cash received from the sale of leasehold improvements and equipment				768			0

Net cash generated / (used) for investing activities				18,272			(37,466	)

Cash flow from financing activities
Proceeds from issue of common shares				7,331			0
Transaction costs related to issue of common shares				(209	)		0
Repayment of lease liabilities				(637	)		(377	)
Repayment of borrowings		12		(4,375	)		(4,447	)

Net cash generated / (used) for financing activities				2,110			(4,824	)

Exchange-rate related changes of cash and cash equivalents				(44	)		(352	)
Net changes to cash and cash equivalents				(31,080	)		(127,117	)
Cash and cash equivalents at the beginning of the period				38,529			190,286

Cash and cash equivalents at the end of the period				7,405			62,817

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

Affimed N.V.

Unaudited consolidated interim statements of changes in equity for the year

(in € thousand)


	Note		Issued capital		Capital reserves		Fair Value reserves			Accumulated deficit			Total equity
Balance as of January 1, 2023				1,493		582,843		(1,231	)		(430,190	)		152,915

Equity-settled share-based payment awards						9,238								9,238
Loss for the period											(85,733	)		(85,733	)

Balance as of September 30, 2023				1,493		592,081		(1,231	)		(515,923	)		76,420

Balance as of January 1, 2024				1,500		593,666		(1,231	)		(536,128	)		57,807

Issue of common shares		10		139		6,881								7,020
Equity-settled share-based payment awards		11				2,133								2,133
Loss for the period											(49,765	)		(49,765	)

Balance as of September 30, 2024				1,639		602,680		(1,231	)		(585,893	)		17,195

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

1.	Reporting entity

Affimed N.V. is a Dutch company with limited liability (naamloze vennootschap) and has its corporate seat in Amsterdam, the Netherlands, 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 and Affimed Inc., Delaware, USA (collectively “Affimed”, the “Company” or the “Group”). Previously the Group also included AbCheck s.r.o., Plzen, Czech Republic, however this wholly owned subsidiary was sold as of December 28, 2023.

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 development programs and strategic collaborations. The Group previously performed research services for third parties under service contracts at its former subsidiary, AbCheck.

In January 2024, Affimed announced a strategic restructuring which led to a reduction of its headcount by approximately 50% via the dissolution of its research and preclinical development departments. During the nine months ended September 30, 2024, the Group incurred €1.6 million as termination expenses, with €1.5 million included in research and development expenses and €0.1 million included in general administrative expenses.

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

Statement of compliance

The unaudited condensed consolidated interim financial statements (referred to as the “interim financial statements”) as of September 30, 2024 and December 31, 2023 and for the three and nine months ended September 30, 2024 and 2023 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, 2023.

The interim financial statements were authorized for issuance by the Company’s Management Board on November 14, 2024.

Going concern

The interim financial statements have been prepared on the basis that the Group will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. As a clinical-stage biopharmaceutical company, the Group has incurred operating losses since inception. As of September 30, 2024, the Group had an accumulated deficit of €585.9 million and total net equity of €17.2 million.

The Group expects it will incur operating losses for the foreseeable future due to, among other things, costs related to continued clinical programs and its administrative organization. Historically, Affimed has successfully financed its operations through collaborations, licensing, venture loans and equity issuances. Based on current operating and budget assumptions, management anticipates that the Group’s cash and cash equivalents and investments, together with anticipated proceeds from the ATM program and the sale of AbCheck, will finance the Group into Q4 2025. In addition, management is pursuing various financing alternatives to meet the Group’s future cash requirements, including the issuance of equity to existing or new shareholders, payments from arrangements with strategic partners and other sources. Based on such operating and budget assumptions, management has concluded that the Group is able to continue as a going concern.

We are advancing our product candidates through clinical development. Developing pharmaceutical products, including conducting preclinical studies and clinical studies, is expensive and highly regulated. In order to obtain necessary regulatory approval, we are required to conduct clinical studies for each of our product candidates and each of their indications. The Group’s clinical programs with acimtamig, AFM24 and AFM28 are still in the development stage. Any further development until market approval and successful financing is dependent on meaningful clinical trial results, among other factors. Achieving such results implies uncertainty, including relating to estimated costs for completing ongoing clinical programs, the timing for bringing such programs to market or for substantially partnering or out-licensing arrangements, among others. It is unknown when, if ever, material cash inflows may commence.

Based on the quality of the Group’s clinical data, management believes that it will be able to obtain financing for the implementation of the Group’s business strategy. If the Company is not able to raise sufficient capital when needed, Affimed could be forced to delay, reduce or eliminate the Company’s product development programs and the ability to continue as a going concern would be uncertain. Based on management’s going concern assessment, the interim financial statements do not include any adjustments that may result from the outcome of these uncertainties.

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.

On March 8, 2024, the Company effected a 1-for-10 reverse stock split of its outstanding common shares. According to IAS 33.64, the Group has adjusted the weighted average number of ordinary shares and the loss per share (diluted/undiluted) retroactively for the for the three and nine months ended September 30, 2023. In addition, all share and per share information (including such information related to share-based payments) have been retroactively adjusted (see note 11).

As of September 30, 2024, the Group has 2,842,659 options and warrants outstanding in connection with share-based payment programs (see note 11) 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 audited consolidated financial statements as of and for the year ended December 31, 2023 except for the following issue:

As of March 31 2024, the lease term for the property leased in Mannheim was reassessed (refer details provided in note 13). The lease term was reduced from 10 years to 5 years. The discount rate was adjusted to align with the revised lease term from 9.56% to 8.06%. The financial effect of this reassessment is an overall decrease in the consolidated depreciation and interest expense as shown below:


Impact of the estimation changes	Depreciation expense - previous		Change			Depreciation expense - revised
2024		825		331			1,156
2025		825		331			1,156
2026		825		331			1,156
2027 and thereafter		5,564		(3,539	)		2,025
Total		8,039		(2,546	)		5,493

	Interest expense - previous		Change			Interest expense - revised
2024		629		(304	)		325
2025		577		(320	)		257
2026		521		(338	)		183
2027 and thereafter		1,756		(1,630	)		126
Total		3,483		(2,592	)		891

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 audited consolidated financial statements as of and for the year ended December 31, 2023.

New standards and amendments to standards

A number of new accounting standards and amendments to accounting standards are effective for annual periods beginning on January 1, 2024 but none of the applied standards had a material effect on these interim financial statements.

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


Standard/interpretation		Effective Date¹
Amendments to IAS 21 The Effects of Changes in Foreign Exchange Rates: Lack of Exchangeability		January 1, 2025
Amendments to IFRS 9 and IFRS 7 Classification and Measurement of Financial Instruments		January 1, 2026
IFRS 18 Presentation and Disclosure in Financial Statements		January 1, 2027
Annual Improvements Volume 11		January 1, 2026

IFRS 18 will have an effect on the presentation of the Group`s financial statements with the following key impacts:

•

Income and expenses will be classified into five categories including the new categories operation, investing and financing, therefore new subtotals will be introduced;

•

Enhanced principles of aggregation and disaggregation will lead to a different grouping of information and/or additional disclosures; and

•

Presentation options in the statements of cash flows will be eliminated leading to a reclassification of cash flows (e.g. interest received and interest paid).

The other 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 Group recognizes transfers between levels of the fair value hierarchy as the date at which the change has occurred. There were no transfers between levels for the periods presented.

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 provided 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. As of the end of 2022, Affimed had completed work on and/or handed over all product candidates for further investigation by Genentech.

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

In the third quarter of 2024, Genentech terminated the research collaboration and license agreement.

The Group recognized €0.2 million and €0.5 million as revenue during the three and nine months ended September 30, 2024 and 2023, respectively. The revenue recognized relates to a platform license. As of September 30, 2024, the Group held contract liabilities of €0.6 million (December 31, 2023: €1.1 million), which will be recognized as revenue in subsequent periods.

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 granted 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. We entered into an agreement with Roivant providing for the reversion to Affimed of all clinical development and commercialization rights for AFM32, effective April 29, 2024.

The Group recognized €0 million as revenue during the three and nine months ended September 30, 2024 (2023: €1.6 million and €6.9 million respectively). As of December 31, 2023, Affimed had completed all work on the product candidate and by March 31, 2024 all remaining funds not utilised for the research project had been refunded. As of December 31, 2023, the liability of €1.4 million with regard to the refund was included under trade and other payables (Contract liabilities as at December 31, 2023: €0).

Contract balances

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


	September 30, 2024		December 31, 2023
Receivables		0		0
Contract liabilities		619		1,083

An amount of €0.2 million and €0.5 million included in contract liabilities at the beginning of the period has been recognized as revenue during the three and nine months ended September 30, 2024.

The remaining obligation as of September 30, 2024 is approximately €0.6 million and is expected to be recognized as revenue over the next 12 months.

Disaggregation of revenue


	Three months ended September 30, 2024		Three months ended September 30, 2023		Nine months ended September 30, 2024		Nine months ended September 30, 2023
Geographic information
Revenue:
Germany		0		5		0		5
USA		15		1,957		464		7,857
		155		1,962		464		7,862
Major service lines:
Collaboration revenue		155		1,713		464		7,384
Service revenue		0		249		0		478
		155		1,962		464		7,862
Timing on revenue recognition:
Point in time		0		0		0		0
Over time		155		1,962		464		7,862
		155		1,962		464		7,862

4.	Operating loss

In January 2024, Affimed announced a strategic restructuring which led to a reduction of its headcount by approximately 50% via the dissolution of its research and preclinical development departments. The Group incurred €1.6 million as termination expenses, with €1.5 million included in research and development expenses and €0.1 million included in general administrative expenses, to be offset by cost savings in 2024 achieved by a reduction in payroll, laboratory activities and related costs. Further, this restructuring resulted in the selling of laboratory equipment which led to an impairment of €1.6 million and an impairment of laboratory inventory of €0.5 million in the nine months ended September 30, 2024.

In April 2023, Affimed had also conducted a reorganization of its operations to focus on the Group’s three clinical stage development programs. As a result, of that reorganization, the Group incurred a one-time expenditure for termination payments of €1.1 million during the nine months ended September 30, 2023.

5.	Finance income and finance costs


	Three months ended September 30, 2024			Three months ended September 30, 2023			Nine months ended September 30, 2024			Nine months ended September 30, 2023
Interest Bootstrap Loan Agreement		(267	)		(447	)		(945	)		(1,394	)
Foreign exchange gains/(losses)		(758	)		353			(252	)		(78	)
Interest on Government treasury bonds		228			138			901			138
Other finance income/(costs) - net		(58	)		524			(94	)		1,430
		(855	)		568			(390	)		96

6.	Investments

As of September 30, 2024, the Group holds investments in Government treasury bonds of €16.7 million (December 31, 2023: €33.5 million). These bonds generated interest income for the three and nine months ended September 30, 2024 of €0.2 million and €0.9 million, respectively (September 30, 2023: €0.1 million for the three and nine month period) recognized in finance income/(cost) net. These investments are considered short-term as they all mature within a period of six months.

7.	Other financial assets

On December 28, 2023, the Group entered into an agreement regarding the sale of its wholly owned subsidiary AbCheck s.r.o. (‘AbCheck sale agreement‘) to Ampersand Biomedicines Inc (‘Ampersand’) for a gross purchase price of €5.8 million ($6.4 million), consisting of €4.9 million ($5.4 million) in cash to be paid in two tranches and €0.9 million ($1.0 million) to be paid by delivery of a variable number of Ampersand shares subject to certain adjustments and a holdback. The first cash tranche of €1.6 million ($1.8 million) was received in December 2023. An additional €0.2 million ($0.2 million) was received in April 2024 after certain accounts were finalized. The settlement of the balance of the purchase price (both cash and shares) is required once Ampersand has completed a financing round but no later than December 31, 2024. As of September 30, 2024, the portion to be settled by way of shares is included under other financial assets and amounts to €0.8 million ($0.9 million) (December 31, 2023: €0.9 million ($0.9 million)); the balance of the cash portion of €2.9 million (December 31, 2023: €3.1 million) is included under trade and other receivables.

8.	Trade and other receivables

The Group had no trade receivables as of September 30, 2024 (December 31, 2023: €0).

Other receivables are all due within the short-term and mainly comprise value-added tax receivables of €0.7 million (December 31, 2023: €0.9 million) and the balance of the consideration of €2.9 million (December 31, 2023: €3.1 million) for the sale of AbCheck to Ampersand, refer note 7.

9.	Other assets and prepaid expenses

The other assets and prepaid expenses as of September 30, 2024 of €2.9 million (December 31, 2023: €5.5 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 €1.6 million (December 31, 2023: €3.4 million) for services to be provided in respect of managing clinical trials, €0.2 million (December 31, 2023: €0.9 million) as a start-up fee for services associated with a clinical trial for the reservation of manufacturing capacity and the directors’ and officers’ liability insurance premium of €0.3 million (December 31, 2023: €0 million).

10.

Equity

The share and per share information presented in this note retrospectively reflects the effects of the reverse stock split effective March 8, 2024, which was approved by the Company’s shareholders at the Company’s Annual General Meeting of Shareholders on June 21, 2023.

At the annual general meeting, held on June 26, 2024, shareholders approved the increase of the authorized share capital to 75,000,000 shares, from 31,195,000 shares.

As of September 30, 2024, the share capital of €1,639 (December 31, 2023: €1,500) is comprised of 16,392,343 (December 31, 2023: 14,998,804) common shares with a par value of €0.10 per share.

In November 2021, we entered into a $100 million ATM program. As of December 31, 2023, 0.08 million common shares were sold, generating net proceeds of €1.8 million in the aggregate. For the three and nine months ended September 30, 2024, an additional 0.7 million and 1.4 million common shares were sold under the ATM program, generating net proceeds of €3.0 million and €7.2 million in the aggregate.

11.

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.

The share and per share information presented in this note retrospectively reflects the effects of the reverse stock split which was effective March 8, 2024.

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 405,500 and 975,750 awards for the three and nine months ended September 30, 2024 to employees, members of the Management Board, members of the Supervisory Board and consultants. Fair value of the awards at grant date for the nine months ended September 30, 2024, amounts to €3.3 million ($3.6 million).

232,628 and 325,604 ESOP 2014 awards were cancelled or forfeited due to termination of employment during the three and nine months ended September 30, 2024 (September 30, 2023: 454,238 and 822,778).

As of September 30, 2024, 2,832,034 ESOP 2014 options were outstanding (December 31, 2023: 2,181,888), and 1,574,774 awards had vested (December 31, 2023: 1,240,852). The options outstanding as of September 30, 2024, had an exercise price in the range of $3.50 to $134.70, a weighted average remaining contractual life of 7.6 years (December 31, 2023: 7.3 years) and a weighted average exercise price of $25.0 (December 31, 2023: $35.7).

Share-based payments with market conditions

During 2022, the Company issued 282,500 options with market-based performance conditions to members of the Management Board and employees. As of September 30, 2024, all of these options had been forfeited.

Fair value of the awards at grant date in 2022 amounted to €2.9 million ($3.2 million) and the contractual lifetime of the options was two years. Any unvested awards on the date that is two years following the grant date would lapse, accordingly these are now all lapsed.

Share-based payment expense

For the three and nine months ended September 30, 2024, compensation expense of €660 and €2,133 was recognized affecting research and development expenses (€0.3 million and €0.9 million) and general and administrative expenses (€0.4 million and €1.3 million). In the three and nine months ended September 30, 2023, compensation expense of €1,848 and €9,238 was recognized affecting research and development expenses (€970 and €4,992) and general and administrative expenses (€879 and €4,247).

Fair value measurement

The fair value of options with service conditions granted in the nine months ended September 30, 2024 and 2023, respectively, was determined using the Black-Scholes-Merton valuation model. The significant inputs into the valuation model are as follows (weighted average):


	September 30, 2024			September 30, 2023
Fair value at grant date	$	3.72		$	7.8
Share price at grant date	$	5.14		$	10.5
Exercise price	$	5.14		$	10.5
Expected volatility		79	%		90	%
Expected life		5.88			5.86
Expected dividends		0.00			0.00
Risk-free interest rate		4.01	%		3.95	%

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.

12.

Borrowings

Bootstrap Europe

In January 2021, the Group entered into a loan agreement with Bootstrap Europe (formerly Silicon Valley Bank German Branch (“SVB”)) which provided 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. The third tranche of €7.5 million expired undrawn at the end of 2022. 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 September 30, 2024, the fair value of the liability did not differ significantly from its carrying amount (€8.1 million).

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 subsidiary, 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.

UniCredit Leasing CZ

In April 2019, the Group (through its previously held subsidiary AbCheck s.r.o.) entered into a loan agreement with UniCredit Leasing CZ for €562. As a result of the sale of AbCheck, the loan was derecognized as of December 28, 2023.

13.

Lease liabilities

As part of the original property lease agreement in Mannheim, additional office space has been made available to the Group and occupation was taken on January 1, 2024. This has resulted in an addition to the right-of-use asset of €0.8 million, and a corresponding increase to the lease liabilities.

The lease term for the property leased in Mannheim has been reassessed considering current events following the restructure relating to exploring financing options and discussions held with the landlord and potential sub lessees. As a result, the Group had concluded that it is highly likely that the Group will opt to exercise the early termination option of the lease and therefore terminate the lease after 5 years, reduced from the original 10 years. Together with the reduction in lease term the discount rate used has also been reviewed and reduced from 9.56% to 8.06% for 2024. The lease liability and right-of-use asset has been adjusted to take these changes into account.

14.

Related parties

The supervisory board directors of Affimed N.V. received compensation in the amounts of €55 and €294 (€119 and €357) for their services on the Supervisory Board in the three and nine months ended September 30, 2024 (2023). Members of the Management Board received compensation in the amounts of €453 and €1,258 (€680 and €2,596) for their services on the Management Board in the three and nine months ended September 30, 2024 (2023).

The Company recognized share-based payment expenses of €15 and €99 (€53 and €248) for supervisory directors and €364 and €714 (€1,003 and €3,957) for managing directors in the three and nine months ended September 30, 2024 (2023).

The following table provides the total amounts of outstanding balances for supervisory board compensation and expense reimbursement:


	Outstanding balances
	September 30, 2024		December 31, 2023
Thomas Hecht		16		21
Mathieu Simon*		—		8
Ulrich Grau*		—		18
Bernhard Ehmer		10		15
Annalisa Jenkins		9		11
Uta Kemmerich-Keil*		—		16
Constanze Ulmer-Eilfort		13		16

*	No longer Supervisory Board members, effective June 26, 2024

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 nine month periods ended September 30, 2024 and 2023 (the “interim financial statements”) 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 2023, and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2023 (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 unaudited condensed consolidated interim financial statements and audited consolidated financial statements in accordance with International Financial Reporting Standards (“IFRS”) as issued by the International Accounting Standards Board (the “IASB”). None of our unaudited condensed consolidated interim financial statements or audited consolidated financial statements are 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 developing highly targeted cancer immunotherapies. Our product candidates are being developed in the field of immune-oncology, which represents an innovative approach to cancer treatment that seeks to harness the body’s own immune defenses to fight tumor cells. The most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (natural killer (“NK”) cells and macrophages) and T cells. Leveraging our fit-for-purpose ROCK^® (Redirected Optimized Cell Killing) platform, we have the potential to develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct and establish a bridge between innate immune cells and cancer cells. Our innate cell engagers have the ability to bring innate immune cells into proximity and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture (which provides for four binding domains), our innate cell engagers bind to their targets with high affinity and have half-lives that allow regular intravenous administration, with different dosing schemes being explored to allow for improved exposure in heavily pretreated patient populations. We believe, based on their mechanism of action and the preclinical and clinical data we have generated to date, that our product candidates, alone 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 immune cell space, we also have the ability to develop novel tetravalent, bispecific antibody formats with the potential to tailor immune-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 September 30, 2024, we have raised an aggregate of approximately €578 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. For the nine months ended September 30, 2024, we incurred a net loss of €49.8 million. As of September 30, 2024, we had an accumulated deficit of €585.9 million.

In December 2023 we reached a definitive agreement to sell our former subsidiary AbCheck s.r.o. (“AbCheck”) to Ampersand Biomedicines. No revenues or expenses of AbCheck are therefore included in the three and nine month periods ended September 30, 2024, whereas in the three and nine month periods ended September 30, 2023, revenues and expenses of AbCheck are included.

On January 8, 2024, we announced a restructuring initiative aimed at transforming us into a focused clinical organization, positioned to successfully advance our programs to key value inflection points. As part of the restructuring, we reduced our workforce by dissolving our research and preclinical development departments.. All restructuring measures have been completed. Based on our operating and budget assumptions, our cash runway is into Q4 2025.

We expect to continue incurring losses as we continue 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 depends on the successful development, approval and commercialization of our product candidates and our ability to achieve a level of revenues adequate to support our cost structure. We may never achieve profitability and unless and until we do, we will continue to need to raise additional cash. We intend to fund future operations through additional equity and debt financing and we may seek additional capital through arrangements with strategic partners or from other sources. See Note 2, Basis of preparation and changes to Group’s accounting policies, Going concern, in the notes to the interim financial statements.

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

Recent Developments

In January 2024, we initiated a strategic restructuring of our operations to focus on our three clinical stage development programs. As a result of the restructuring, we reduced our full-time equivalent headcount by approximately 50%. We incurred a one-time cash expenditure for termination payments of approximately €1.6 million. Further, the financial impact from the selling of laboratory equipment resulted in an impairment of €1.6 million in the six months ended June 30, 2024.

On March 6, 2024, we announced a 1-for-10 reverse stock split of our outstanding common shares, effective after market close on March 8, 2024.

In May 2024, the U.S. Food and Drug Administration granted a Fast Track designation to the combination of our innate cell engager (ICE^®) AFM24 with atezolizumab for the treatment of patients with advanced and/or metastatic non-small cell lung cancer (“NSCLC”) epidermal growth factor receptor (“EGFR”)-wildtype (“wt”) after progression on PD-(L)1 targeted therapy and platinum-based chemotherapy. Fast Track is a process designed to facilitate the development and expedite the review of new drugs that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need.

On June 1, 2024, we announced a AFM24-102 phase 2 study update from the NSCLC EGFRwt cohort. As of the updated data cutoff on May 13, 2024 for the 17 EGFRwt patients previously reported on, 15 patients were response-evaluable. Four confirmed objective responses were seen: 1 complete response (“CR”) and 3 partial responses (“PR”). In addition, 8 patients achieved stable disease (“SD”), resulting in a disease control rate of 71%. Importantly, all responding patients had a documented progression on their previous PD targeting therapy. Median progression-free survival was 5.9 months with median follow-up of 7.4 months. These data are remarkable as little progress has been made in the therapy for NSCLC patients who fail platinum-based therapy as well as PD1. Standard of care is still single agent Docetaxel which produces a response rate of approximately 10% and a PFS of 4.0 – 4.5 months.

On June 26, 2024, we held our annual general meeting, at which, among other things, shareholders authorized our management board to issue, and/or grant rights to subscribe for, up to an additional 15,227,463 shares in the share capital of the Company until December 26, 2025, that is, up to a maximum of 30,454,926 shares, of which 15,227,463 shares were issued and outstanding as of the date of the meeting, and to exclude pre-emptive rights accruing to shareholders in respect of an issuance of such shares, or granting of such rights, until December 26, 2025.

On September 3, 2024, we announced that Dr. Shawn M. Leland, PharmD, RPh was appointed as Chief Executive Officer (CEO). Dr. Andreas Harstrick, who had been serving as acting CEO since January 2024, remained in his position as Chief Medical Officer.

On September 5, 2024, we announced a AFM24-102 phase 2 study update from the EGFR mutant (“EGFRmut”) cohort. 24 heavily pretreated EGFRmut NSCLC patients are in the trial and, of 17 patients that are response evaluable per protocol, 1 CR, 3 PR and 8 SD were observed. All responses were confirmed by follow-up scan. Median follow-up is more than 7 months, and 8 out of the 17 patients continue on treatment. All 4 responders remained on treatment for at least 7 months. The EGFRwt NSCLC cohort for patients who failed chemotherapy and PD-1/PD-L1 has continued enrollment with 40 patients on trial. ORR and safety data from the EGFRwt cohort are expected in Q4 2024. Overall response and PFS data from EGFRmut and PFS data from the EGFRwt cohorts are expected to be presented at a major scientific conference in H1 2025.

On September 5, 2024, we announced a data update from the LuminICE-203 study (acimtamig/AlloNK^® co-administered combination therapy in relapsed/refractory (“R/R”) Hodgkin lymphoma (“HL”). The recruitment in cohorts 1 and 2 is completed and for the 12 treated refractory HL patients, an objective response rate of 83.3% with 6 CRs and 4 PRs were observed by independent read. Treatment-related adverse events were consistent with previous experience, and side effects related to acimtamig and AlloNK^® were well manageable with standard of care treatment. Recruitment in cohorts 3 and 4 has meanwhile been completed and updated study results will be reported at the 66th ASH Annual Meeting and Exposition in December 2024.

On September 5, 2024, we further announced a data update from the multi-center Phase 1 open-label, dose-escalation study (AFM28-101), of AFM28 monotherapy in CD123-positive R/R AML. Of 6 patients treated at dose level 6 at 300 mg, 1 patient showed a CR, 2 patients showed a CRi (complete remission with incomplete hematologic recovery) and 2 patients achieved SD. As previously announced in June 2024, at dose level 5 at 250 mg, out of 6 patients 1 patient showed a CR, lasting 6 months. The other 5 patients reached a SD as best response. No dose-limiting toxicities were reported in dose levels 5 and 6. We will enroll additional 6 patients in this study at dose level 6. Updated response and safety data will be reported at the 66th ASH Annual Meeting and Exposition in December 2024.

On November 5, 2024, we announced the acceptance of three abstracts on two of our ICE^® therapies for presentation at the 66th ASH Annual Meeting and Exposition taking place December 7-10, 2024, in San Diego, California. An oral presentation will feature clinical results, including promising efficacy and safety data from the AFM28 phase 1 dose escalation study in R/R AML. A poster with preclinical data will highlight the in vitro efficacy of AFM28 in combination with both patient-derived autologous NK cells and healthy volunteer-derived allogeneic NK cells against leukemic blasts. Updated clinical results from all 4 cohorts of the run-in phase from the LuminICE-203 study evaluating acimtamig in combination with AlloNK^® (AB-101) for relapsed/ refractory Hodgkin Lymphoma will be shared in a poster session.

Collaboration and License Agreements

We finalized an agreement with Roivant Sciences Ltd. (“Roivant”) providing for the reversion to Affimed of all clinical development and commercialization rights for AFM32, effective April 29, 2024.

In the third quarter of 2024, Genentech terminated the research collaboration and license agreement.

There have been no other 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 expenses for our ongoing clinical programs. Our research and development expenses are highly dependent on the development phases of our projects and therefore fluctuate widely from period to period. Our remaining research and continued development expenses mainly relate to the following key programs:

•

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

•

In January 2023, the Food and Drug Administration (“FDA”) issued a written response to our pre-investigational new drug (“IND”) meeting request for the acimtamig/AlloNK^® co-administered combination therapy in relapsed/refractory (“R/R”) Hodgkin lymphoma (“HL”) and the exploratory arm evaluating the combination in r/r CD30+ peripheral T cell lymphoma (“PTCL”). Based on the written response, we submitted and received clearance from the FDA for an IND application during the second quarter of 2023. We initiated enrollment into the study in October 2023. The recruitment in cohorts 1 and 2 is completed and for the first 12 treated refractory Hodgkin Lymphoma (HL) patients, an overall response rate (ORR) of 83.3% with 6 complete responses (CRs) and 4 partial responses (PRs) was observed by independent read.

•

In December 2023, we presented final data from the investigator-initiated trial at the American Society of Hematology (“ASH”) 2023 Annual Meeting. A total of 42 patients were enrolled in the study with 36 patients treated at the recommended phase 2 dose (“RP2D”). 32 of the 36 patients treated at the RP2D were HL patients. All 32 HL patients were heavily pretreated with multiple lines of chemotherapy, all had previously received checkpoint inhibitors (“CPIs”) and brentuximab vedotin (“BV”), and were refractory to their most recent line of therapy with active progressive disease at the time of enrollment. Across all dose levels, the treatment regimen achieved an objective response rate (“ORR”) of 93% with a CR rate of 67%; among the 32 HL patients treated at the RP2D the treatment regimen achieved an ORR of 97% and a CR rate of 78%. In addition, the treatment regimen demonstrated a good safety and tolerability profile with no cases of cytokine release syndrome (“CRS”), immune effector cell-associated neurotoxicity syndrome (“ICANS”) or graft versus host disease (“GvHD”) of any grade. Mild to moderate infusion related reactions (“IRRs”)

were seen in 7.7% of the acimtamig infusions. Across all dose levels, median event free survival (“EFS”) was 8.8 months and median overall survival (“OS”) was not reached. For the HL patients treated at the RP2D, median EFS was 9.8 months – with 84% patients alive at 12 months. The median duration of response (“DoR”) was 8.8 months and 72% CR assessed at 6 months for HL patients treated at the RP2D; 30% of patients with complete response remained in CR beyond 12 months.

•

In December 2022, we released topline data from our phase 2 REDIRECT study investigating acimtamig monotherapy in patients with advanced-stage R/R PTCL. Primary efficacy measures include ORR of 32.4% and a CR rate of 10.2%. Key secondary and exploratory outcome measures include safety, durability of response, PFS and OS. The safety profile of acimtamig was well managed and consistent with previously reported data of prior and ongoing clinical studies with acimtamig. Median 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 HL for the combination of acimtamig with cord blood-derived NK cells in the acimtamig (AFM13-104) study, we believe that the combination with AB-AlloNK^® 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 as compared to acimtamig monotherapy in PTCL. Accordingly, we do not intend to pursue an accelerated approval for acimtamig monotherapy in PTCL and will focus investment on clinical development in the combination of acimtamig and AlloNK^®.

•

In November 2022, we announced a new strategic partnership with Artiva Biotherapeutics, Inc. (“Artiva”) to jointly develop, manufacture and commercialize the combination of acimtamig and AlloNK^®. Under the terms of the agreement, we and Artiva will pursue the development of the acimtamig/AlloNK^® combination treatment in the United States on a co-exclusive basis. We will lead regulatory activities through phase 2 and any confirmatory studies. We will be responsible for funding clinical study costs through phase 2, while Artiva will be responsible for the costs of supplying AlloNK^® 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. We will be responsible for promotional activities and expenses of the combination therapy. Pursuant to the agreement, revenues from the strategic partnership will be shared, with us receiving 67% of the combination therapy revenue and Artiva receiving 33%.

We anticipate that our research and development expenses in 2024 for acimtamig will decrease significantly compared to those for 2023, mainly due to lower expenses for manufacturing activities.

•

AFM24. AFM24 is a tetravalent, bispecific epidermal growth factor receptor and CD16A-binding innate cell engager. We reported data at the American Society of Clinical Oncology Annual Meeting in June 2024 and announced a data update in September 2024 from our ongoing combination study with atezolizumab. In the latest data update in September, we reported that 24 heavily pretreated EGFRmut NSCLC patients are in the trial and, of 17 patients that are response evaluable per protocol, 1 CR, 3 PR and 8 SD were observed. All responses were confirmed by follow-up scan. Median follow-up is more than 7 months, and 8 out of the 17 patients continue on treatment. All 4 responders remained on treatment for at least 7 months. The EGFRwt NSCLC cohort for patients who failed chemotherapy and PD-1/PD-L1 has continued enrollment with 40 patients on trial. We anticipate that our research and development expenses in 2024 for AFM24 will decrease compared to those in 2023, primarily due to the decline in manufacturing activities for clinical trial materials as we focus on clinical development.

•

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 (“LSCs”) in patients with acute myeloid leukemia (“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 United States. Clinical trial applications were cleared in Belgium, Denmark, France and Spain and we initiated recruitment into a phase 1 clinical study in the first quarter of 2023. The enrollment of the sixth and final cohort is completed. Of 6 patients treated at dose level 6 at 300 mg, 1 patient showed a CR, 2 patients a CRi and 2 patients achieved SD. We will enroll additional 6 patients in this study at dose level 6.

•

Other projects and infrastructure costs. Our other research and development expenses relate to our Roivant and Artiva collaborations, and early-stage development/discovery activities, which were active until the end of 2023. We had allocated a material amount of our resources to such discovery activities. The expenses mainly consisted of salaries, manufacturing costs for pre-clinical study material and pre-clinical studies. In addition, we incurred a significant amount of costs associated with our research and development that was 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 2024 due to the dissolving of early-stage discovery activities.

Results of Operations

The financial information shown below was derived from our interim financial statements for the three months period ended September 30, 2024 and 2023. The discussion below should be read along with these financial statements and is qualified in its entirety by reference to them.

Comparison of the three months ended September 30, 2024 and 2023


	Three months ended September 30,
	2024			2023
	(unaudited)
	(in € thousand)
Total Revenue		155			1,962
Other income (expenses) — net		9			(6	)
Research and development expenses		(10,136	)		(21,498	)
General and administrative expenses		(4,311	)		(5,381	)
Operating loss		(14,283	)		(24,923	)
Finance income/(costs) — net		(855	)		568
Loss before tax		(15,138	)		(24,355	)
Income taxes		(1	)		—
Loss for the period		(15,139	)		(24,355	)
Other comprehensive loss		—			—
Total comprehensive loss		(15,139	)		(24,355	)
Basic loss per common share in € per share (undiluted = diluted)		(0.94	)		(1.63	)

Revenue

Revenue decreased to €0.2 million in the three months ended September 30, 2024 from €2.0 million for the three months ended September 30, 2023. Revenue in the three months ended September 30, 2024, relates to the Genentech Inc. (“Genentech”) collaboration with €0.2 million in relation to a platform license, while 2023 predominantly related to the Roivant collaboration, which was €1.6 million. Revenue from the Roivant collaboration in the three months ended September 30, 2023 comprised revenue recognized from collaborative research services performed during the quarter.

Research and development expenses


	Three months ended September 30
	2024		2023		Change %
	(unaudited)
R&D Expenses by Project	(in € thousand)
Project
acimtamig		2,834		10,559		(73	%)
AFM24		2,781		3,693		(25	%)
AFM28		809		1,335		(39	%)
Other projects and infrastructure costs		3,408		4,941		(31	%)
Share-based payment expense		304		970		(69	%)
Total		10,136		21,498		(53	%)

Research and development expenses amounted to €10.1 million in the three months ended September 30, 2024 compared to research and development expenses of €21.5 million in the three months ended September 30, 2023. The decrease in project-related expenses between the projects for the three months ended September 30, 2024 and the corresponding period in 2023 are mainly due to the following:

•

acimtamig. In the three months ended September 30, 2024, we incurred lower expenses (73%) than in the three months ended September 30, 2023, primarily due to the decrease in manufacturing activities for clinical trial material and a decline in clinical trial costs.

•

AFM24. In the three months ended September 30, 2024, we incurred lower expenses (25%) than in the three months ended September 30, 2023, due to the decline in manufacturing activities for clinical trial materials as we focus on clinical development.

•

AFM28. In the three months ended September 30, 2024, we incurred lower expenses (39%) than in the three months ended September 30, 2023, due to a decrease in costs for preclinical development activities, as well as manufacturing costs for clinical trial material.

•

Other projects and infrastructure costs. In the three months ended September 30, 2024, expenses were lower (31%) than in the three months ended September 30, 2023, primarily due to a decline in costs incurred with respect to certain of our collaboration projects, such as the Roivant and Genentech collaboration, for which we have completed the work assigned to us under the respective collaboration agreements, set-off by a one-time termination expenditure. Further, the decrease is also attributable to lower costs following the sale of our subsidiary AbCheck and lower costs following the restructuring initiatives.

•

Share-based payment expense. In the three months ended September 30, 2024, this expense decreased by 69% compared to the three months ended September 30, 2023, due to a decrease in the number of newly issued share options and a reduction in head count.

General and administrative expenses

General and administrative expenses amounted to €4.3 million in the three months ended September 30, 2024 compared to €5.4 million in the three months ended September 30, 2023. These costs have decreased (20%) as a result of the decline in head count, decline in legal and consulting, insurance expenses and share-based payment expenses impacted by the decline in head count.

Finance income / (costs)-net

Finance costs for the three months ended September 30, 2024 totaled €0.9 million, compared to finance income of €0.6 million for the three months ended September 30, 2023. Finance income/costs in the three months ended September 30, 2024 and 2023 are primarily made up of foreign exchange gains / losses related to cash, cash equivalents and government treasury bonds denominated in U.S. dollars as a result of the change in the value of the U.S. dollar compared to the Euro, interest on our January 8, 2021 loan agreement with Bootstrap Europe (formerly Silicon Valley Bank German Branch (the “Bootstrap Loan”) and interest earned on the treasury bonds.

Comparison of the nine months ended September 30, 2024 and 2023


	Nine months ended September 30,
	2024			2023
	(unaudited)
	(in € thousand)
Total Revenue		464			7,862
Other income/(expenses) — net		242			1,121
Research and development expenses		(37,254	)		(76,302	)
General and administrative expenses		(12,823	)		(18,507	)
Operating loss		(49,371	)		(85,826	)
Finance income/(costs) — net		(390	)		96
Loss before tax		(49,761	)		(85,730	)
Income taxes		(4	)		(3	)
Loss for the period		(49,765	)		(85,733	)
Total comprehensive loss		(49,765	)		(85,733	)
Basic loss per common share in € per share (undiluted = diluted)		(3.20	)		(5.74	)

Revenue

Revenue decreased from €7.9 million in the nine months ended September 30, 2023 to €0.5 million for the nine months ended September 30, 2024. Revenue in the nine months ended September 30, 2024, relates to the Genentech Inc. (“Genentech”) collaboration with €0.5 million in relation to a platform license, while 2023 predominantly related to the Roivant collaboration, which was €6.9 million. Revenue from the Roivant collaboration in the nine months ended September 30, 2023 comprised revenue recognized from collaborative research services performed during the quarter.

Research and development expenses


	Nine months ended September 30
	2024		2023		Change %
	Unaudited
R&D Expenses by Project	(in € thousand)
Project
acimtamig		9,001		27,403		(67	%)
AFM24		9,043		15,761		(43	%)
AFM28		3,513		4,540		(23	%)
Other projects and infrastructure costs		14,841		23,606		(37	%)
Share-based payment expense		856		4,992		(83	%)
Total		37,254		76,302		(51	%)

Research and development expenses decreased from €76.3 million in the nine months ended September 30, 2023 to €37.3 million for the nine months ended September 30, 2024. The decrease in project-related expenses between the projects for the nine months ended September 30, 2024 and the corresponding period in 2023 are mainly due to the following:

•

acimtamig. In the nine months ended September 30, 2024 we incurred lower expenses (67%) than in the nine months ended September 30, 2023 primarily due to the scaling down of manufacturing activities for clinical trial material and a decline in clinical trial costs.

•

AFM24. In the nine months ended September 30, 2024, we incurred lower expenses (43%) than in the nine months ended September 30, 2023 due to the decline in manufacturing activities for clinical trial materials as we focus on clinical development.

•

AFM28. In the nine months ended September 30, 2024, we incurred lower expenses (23%) than in the nine months ended September 30, 2023 due to overall lower costs for preclinical development activities.

•

Other projects and infrastructure costs. In the nine months ended September 30, 2024, expenses were lower (37%) than in the nine months ended September 30, 2023, primarily due to a decline in costs incurred with respect to certain of our collaboration projects, such as the Roivant and Genentech collaboration, for which we have completed the work assigned to us under the respective collaboration agreements. Further, the decrease is also attributable to lower costs following the sale of our subsidiary AbCheck. The decline in other projects and infrastructure costs was offset by a one-time cash expenditure for termination payments of approximately €1.5 million, impairment of laboratory equipment of €1.6 million and impairment of inventory of €0.5 million.

•

Share-based payment expense. In the nine months ended September 30, 2024, this expense decreased by 83% compared to the nine months ended September 30, 2023, due to a decrease in the number of newly issued share options and to a reduction in head count, as well as to a reduction in the underlying fair value of newly issued share options.

General and administrative expenses

General and administrative expenses amounted to €12.8 million in the nine months ended September 30, 2024 compared to €18.5 million in the nine months ended September 30, 2023. These costs have declined (31%) 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.

Finance income / (costs)-net

Finance costs for the nine months ended September 30, 2024 totaled €0.4 million, compared to finance income of €0.1 million for the nine months ended September 30, 2023. Finance income/(costs) in the nine months ended September 30, 2024 are primarily made up of foreign exchange gains/(losses) related to cash, cash equivalents and government treasury bonds denominated in U.S. dollars as a result of the change in the value of the U.S. dollar compared to the Euro, interest on our Bootstrap Loan and interest earned on the treasury bonds. Finance income/(costs) in the nine months ended September 30, 2023 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.

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 public offerings of common shares, private placements of equity securities and loans, grants and payments from collaboration partners.

Cash flows

The table below summarizes our consolidated statement of cash flows for the nine months ended September 30, 2024 and 2023:


	Nine months ended September 30,
	2024			2023
	(unaudited)
	(in € thousand)
Net cash used in operating activities		(51,462	)		(84,827	)
Net cash generated/(used) in investing activities		18,272			(37,466	)
Net cash generated/(used) in financing activities		2,110			(4,824	)
Exchange rate related changes of cash and cash equivalents		(44	)		(352	)
Net changes to cash and cash equivalents		(31,080	)		(127,117	)
Cash and cash equivalents at the beginning of the period		38,529			190,286
Cash and cash equivalents at the end of the period		7,405			62,817

Net cash used in operating activities of €51.5 million in the nine months ended September 30, 2024 is lower than net cash used in operating activities in the nine months ended September 30, 2023 (€84.8 million), mainly due to our reduction in research and development expenditure and head count reduction. Net cash generated in investing activities in the nine months ended September 30, 2024 (€18.3 million) primarily resulted from the sale of government treasury bonds. Net cash generated in financing activities in the nine months ended September 30, 2024 (€2.1 million) resulted primarily from the payment of lease liabilities and the monthly Bootstrap loan installments, offset by cash generated from the issuance of common shares, while cash used in financing activities in the nine months ended September 30, 2023 was primarily used for the payment of lease liabilities and the monthly Bootstrap loan installments.

Cash and Funding Sources

Our cash and cash equivalents and investments as of September 30, 2024 were €24.1 million, compared with €72.0 million as of December 31, 2023. Funding sources generally comprise proceeds from the issuance of equity instruments, loans, payments from collaboration agreements and government grants.

Going concern

Our interim financial statements have been prepared on the basis that we will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities and commitments in the normal course of business. As a clinical-stage biopharmaceutical company, we have incurred operating losses since inception. As of September 30, 2024, we had an accumulated deficit of €585.9 million and total net equity of €17.2 million.

We expect to incur operating losses for the foreseeable future due to, among other things, costs related to our continued clinical programs and their administrative organization. Historically, we have successfully financed our operations through collaborations, licensing, venture loans and equity issuances. Based on our current operating and budget assumptions, we anticipate that our cash and cash equivalents and investments, together with anticipated proceeds from the ATM program and the sale of AbCheck, will finance us into Q4 2025. In addition, management is pursuing various financing alternatives to meet future cash requirements, including the issuance of equity to existing or new shareholders, payments from arrangements with strategic partners and other sources. Based on such operating and budget assumptions, management has concluded that the Group is able to continue as a going concern.

We are advancing our product candidates through clinical development. Developing pharmaceutical products, including conducting preclinical studies and clinical studies, is expensive and is highly regulated. In order to obtain necessary regulatory approval, we are required to conduct clinical studies for each of our product candidates and each of their indications. Our clinical programs with acimtamig, AFM24 and AFM28 are still in the development stage. Any further development until market approval and successful financing is dependent on meaningful clinical trial results, among other factors. Achieving such results implies uncertainty, including relating to estimated costs for completing our ongoing clinical programs, the timing for bringing such programs to market or for substantially partnering or out-licensing arrangements, among others. It is unknown when, if ever, material cash inflows may commence.

Based on the quality of the Group’s clinical data, management believes that it will be able to obtain financing for the implementation of the Group’s business strategy. If we are not able to raise sufficient capital when needed, we could be forced to delay, reduce or eliminate our product development programs and our ability to continue as a going concern would be uncertain. Based on management’s going concern assessment, our interim financial statements do not include any adjustments that may result from the outcome of these uncertainties.

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 acimtamig, AFM24 and AFM28. If we receive regulatory approval for acimtamig, 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 Q4 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.

Quantitative and Qualitative Disclosures About Market Risk

During the nine months ended September 30, 2024, 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

As of March 31, 2024, the lease term for the property leased in Mannheim has been reassessed and reduced to 5 years from 10 years and the relating right-of-use asset and lease liability have been adjusted accordingly. See Note 2, Basis of preparation and changes to Group’s accounting policies, and note 13, Lease liabilities, in the notes to our interim financial statements.

There have been no additional 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, Basis of preparation and changes to Group’s accounting policies in the notes to our interim financial statements with regard to the impact of recent accounting pronouncements.

Cautionary Statement Regarding Forward Looking Statements

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

•

our operation as a development stage company with a history of operating losses; as of September 30, 2024, our accumulated deficit was €585.9 million;

•

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. See Note 2, Basis of preparation and changes to Group’s accounting policies, Going concern, in the notes to our interim financial statements for additional information;

•

our ability, based upon our operating and budget assumptions, cash and cash equivalents and investments of approximately €24.1 million as of September 30, 2024, and assumptions regarding proceeds of future issuances under our ATM program and from the sale of AbCheck, to finance our operations into Q4 2025 and beyond;

•

our corporate restructuring and the associated headcount reduction could disrupt our business;

•

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 dependence on the success of acimtamig, AFM24 and AFM28 (which are still in clinical development), 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 acimtamig in combination with NK cell therapy is based on acimtamig 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 acimtamig;

•

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

•

decisions made by the United States FDA and other regulatory authorities with respect to the development and commercialization of our products, including decisions regarding accelerated approval with respect to the LuminICE-203 study design;

•

the outcome of any discussions we may enter into 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 clinical or commercial stage;

•

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

•

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

•

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

•

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

•

our reliance on our current strategic relationships with NKGen Biotech and Artiva 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 ability to retain key personnel and recruit additional qualified personnel;

•

the widespread outbreak of an illness or communicable disease or any other public health crisis, similar to the recent COVID-19 pandemic;

•

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 or the conflict in the Middle East, 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 transpire or occur, what impact they will have on our results of operations, cash flows or financial condition. 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.

Exhibit 99.3

LOGO

PRESS RELEASE

Affimed Reports Third Quarter 2024 Financial Results & Business Update

•

AFM24 combination with atezolizumab: The non-small cell lung cancer (NSCLC) EGFR wild-type (EGFRwt) cohort completed enrollment: Objective response rate (ORR) and safety data to be presented on a Company conference call on December 17, 2024.

•

Acimtamig (AFM13) combination with AlloNK^® (AB-101): Updated clinical data from the four cohorts of the run-in phase to be presented in a poster session at ASH 2024.

•

AFM28 monotherapy phase 1 dose-escalation study: Updated clinical data to be presented at an oral presentation at ASH 2024.

•

Cash runway into Q4 2025: As of September 30, 2024, cash, cash equivalents and investments were €24.1 million. Based on operating and financial plans cash-runway projected into Q4 2025.

Mannheim, Germany, November 14, 2024 – 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 quarter ended September 30, 2024.

“Our innate cell engager therapies are meeting the critical needs of cancer patients who often come to us after exhausting nearly all other treatment options. The responses we’ve observed, even in the heavily pre-treated populations, give us tremendous confidence,” said Dr. Shawn Leland, Chief Executive Officer of Affimed. “With clinical proof of concept established for all our innate cell engagers, the demonstrated activity across both hematological and solid tumors, combined with a strong safety profile, underscores the potential of our platform. We are refining our strategy to focus on clinical priorities and commercial viability, ensuring that our therapies deliver meaningful, long-term impact. I’m also very excited about expanding our efforts to seek collaborations with potential partners who share our vision to drive success for both patients and stakeholders.”

Pipeline Highlights:

AFM24 (EGFR / CD16A)

In the AFM24-102 trial (combination with atezolizumab):

•

The cohort of NSCLC EGFRwt patients who failed chemotherapy and PD-1/PD-L1 has completed enrollment. ORR and safety data for this cohort will be presented on a Company conference call on December 17, 2024.

•

As previously reported at ASCO 2024, in 17 EGFRwt NSCLC patients who failed chemotherapy and PD-1/PD-L1 treatment, 1 complete response (CR), 3 partial responses (PRs) and 8 stable diseases (SDs) had been observed. Disease control was 71%. At the time, 3 of the 4 responses were ongoing for more than 7 months and median progression free survival (PFS) was 5.9 months.

•

PFS data from the EGFRwt and ORR and PFS data from the EGFR mutant (EGFRmut) cohorts expected to be presented at a major scientific conference in H1 2025.

Acimtamig (AFM13) (CD30 / CD16A)

•

Updated clinical data from the four cohorts of the run-in phase of the LuminICE-203 study will be shared in a poster session at ASH 2024.

•

As previously reported on the Company’s Q2 2024 earnings call, in the phase 2 LuminICE-203 trial, 12 patients with advanced, treatment-refractory Hodgkin Lymphoma in cohorts 1 and 2, treated with a combination of the CD30-targeting innate cell engager acimtamig (AFM13) and AlloNK, demonstrated high efficacy, with an ORR of 83.3% and a CRR of 50%.

AFM28 (CD123 / CD16A)

•

An oral presentation at ASH 2024 will feature updated clinical data including efficacy and safety data from the AFM28 phase 1 dose escalation study in relapsed/refractory acute myeloid leukemia (AML).

•

A poster with preclinical data will highlight the in vitro efficacy of AFM28 in combination with both patient-derived autologous NK cells and healthy volunteer-derived allogeneic NK cells against leukemic blasts.

•

As previously reported, initial data on the six patients treated at dose level 6 at 300 mg in the multi-center phase 1 open-label, dose-escalation study (AFM28-101), of AFM28 monotherapy in CD123-positive r/r AML, showed 1 patient with a CR, 2 patients with a CRi for a composite complete remission (CRc) rate (defined as CR+CRi) of 50% (3/6).

•

An additional six patients have been enrolled in the 300 mg cohort.

Upcoming Milestones:

•

LuminICE-203: Efficacy update of four cohorts to be presented at ASH 2024.

•

AFM24-102: ORR and safety data from the EGFRwt cohort to be presented at a Company conference call on December 17, 2024.

•

AFM28-101: Updated data from the dose escalation to be presented at ASH 2024.

•

AMF24-102: ORR and PFS data from the EGFRmut and PFS data from the EGFRwt cohorts expected to be presented at a major scientific conference in H1 2025.

Third Quarter 2024 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 September 30, 2024, cash, cash equivalents and short-term investments totaled €24.1 million. Based on current operating and budget assumptions, the Company expects that cash, cash equivalents and investments, together with anticipated proceeds from its ATM program and the sale of AbCheck, will finance its operations into Q4 of 2025.

Net cash used in operating activities for the quarter ended September 30, 2024, was €11.1 million compared to €18.3 million for the quarter ended September 30, 2023. The decline was mainly due to lower research and development expenditure and personnel expenses.

Total revenue for the quarter ended September 30, 2024, was €0.2 million compared with €2.0 million for the quarter ended September 30, 2023. Revenue in 2024 only related to a platform license provided to Genentech and 2023 predominantly related to the Roivant research collaborations for which all work has been completed.

Research and development expenses for the quarter ended September 30, 2024, were €10.1 million compared to €21.5 million in 2023. The decrease was primarily a result of lower expenses associated with the development of acimtamig and AFM24, due to a decrease in procurement of clinical trial material, clinical trial costs and manufacturing costs, decrease in head count due to the corporate restructuring.

General and administrative expenses for the quarter ended September 30, 2024, were €4.3 million compared to €5.4 million for the quarter ended September 30, 2023. The decrease was due to the decline in headcount, in legal and consulting expenses, insurance expenses and share-based payment expenses.

Net loss for the quarter ended September 30, 2024, was €15.1 million, or €0.94 loss per common share compared with a net loss of €24.4 million, or €1.63 loss per common share, for the quarter ended September 30, 2023.

The weighted number of common shares outstanding for the quarter ended September 30, 2024, was 16,100,185 shares.

Additional information regarding these results will be included in the notes to the consolidated financial statements as of September 30, 2024, 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 November 14, 2024, at 8:30 a.m. EST / 14:30 CET to discuss third quarter 2024 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/BIb9251d6bc6504a4da37a53cdb1b0ac94, 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 innate cell engagers (ICE^®) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE^® are generated on the Company’s proprietary ROCK^® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE^® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, 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 acimtamig (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) acimtamig in combination with NK cell therapy is based on AFM13 (acimtamig) precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AlloNK^® (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

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 September 30						For the nine months ended September 30
	2024			2023			2024			2023
Revenue		155			1,962			464			7,862

Other income – net		9			(6	)		242			1,121
Research and development expenses		(10,136	)		(21,498	)		(37,254	)		(76,302	)
General and administrative expenses		(4,311	)		(5,381	)		(12,823	)		(18,507	)


Operating loss		(14,283	)		(24,923	)		(49,371	)		(85,826	)

Finance income / (costs) – net		(855	)		568			(390	)		96


Loss before tax		(15,138	)		(24,355	)		(49,761	)		(85,730	)

Income taxes		(1	)		0			(4	)		(3	)


Loss for the period		(15,139	)		(24,355	)		(49,765	)		(85,733	)


Total comprehensive loss		(15,139	)		(24,355	)		(49,765	)		(85,733	)


Basic and diluted loss per share in € per share (undiluted = diluted)		(0.94	)		(1.63	)		(3.20	)		(5.74	)
Weighted number of common shares outstanding		16,100,185			14,933,934			15,553,627			14,933,934

Affimed N.V.

Consolidated interim statements of financial position

(in € thousand)


	September 30, 2024 (unaudited)			December 31, 2023
ASSETS
Non-current assets
Intangible assets		15			25
Leasehold improvements and equipment		2,246			4,905
Right-of-use assets		5,307			8,039

		7,568			12,969
Current assets
Cash and cash equivalents		7,405			38,529
Investments		16,695			33,518
Other financial assets		840			851
Trade and other receivables		4,543			5,327
Inventories		0			463
Other assets and prepaid expenses		2,908			5,500

		32,391			84,188

TOTAL ASSETS		39,959			97,157

EQUITY AND LIABILITIES
Equity
Issued capital		1,639			1,500
Capital reserves		602,680			593,666
Fair value reserves		(1,231	)		(1,231	)
Accumulated deficit		(585,893	)		(536,128	)

Total equity		17,195			57,807

Non current liabilities
Borrowings		2,231			6,319
Contract liabilities		0			464
Lease liabilities		3,755			6,660

Total non-current liabilities		5,986			13,443

Current liabilities
Trade and other payables		9,256			18,916
Borrowings		5,833			5,833
Lease liabilities		1,070			539
Contract liabilities		619			619

Total current liabilities		16,778			25,907
TOTAL EQUITY AND LIABILITIES		39,959			97,157

Affimed N.V.

Unaudited consolidated interim statements of cash flows

(in € thousand)


	For the nine months ended September 30
	2024			2023
Cash flow from operating activities
Loss for the period		(49,765	)		(85,733	)
Adjustments for the period:
- Income taxes		4			3
- Depreciation and amortization		2,945			1,273
- Net (gain)/loss on disposal of leasehold improvements and equipment		(24	)		74
- Loss from write-down of inventories		456			0
- Share-based payments		2,133			9,238
- Finance income / (costs) – net		390			(96	)

		(43,861	)		(75,241	)
Change in trade and other receivables		783			251
Change in inventories		7			(181	)
Change in other assets and prepaid expenses		2,641			(3,639	)
Change in trade, other payables, provisions and contract liabilities		(10,276	)		(6,442	)

		(50,706	)		(85,252	)
Interest received		203			1,497
Paid interest		(955	)		(1,069	)
Paid income tax		(4	)		(3	)

Net cash used in operating activities		(51,462	)		(84,827	)


Cash flow from investing activities
Purchase of leasehold improvements and equipment, including upfront payments for right-of-use assets		(25	)		(3,220	)
Cash received from the sale of financial assets		17,529			0
Cash paid for investments in financial assets		0			(34,246	)
Cash received from the sale of leasehold improvements and equipment		768			0

Net cash generated / (used) for investing activities		18,272			(37,466	)


Cash flow from financing activities
Proceeds from issue of common shares		7,331			0
Transaction costs related to issue of common shares		(209	)		0
Repayment of lease liabilities		(637	)		(377	)
Repayment of borrowings		(4,375	)		(4,447	)

Net cash generated / (used) for financing activities		2,110			(4,824	)


Exchange-rate related changes of cash and cash equivalents		(44	)		(352	)
Net changes to cash and cash equivalents		(31,080	)		(127,117	)
Cash and cash equivalents at the beginning of the period		38,529			190,286

Cash and cash equivalents at the end of the period		7,405			62,817

Affimed N.V.

Unaudited consolidated interim statements of changes in equity for the year

(in € thousand)


	Issued capital		Capital reserves		Fair Value reserves			Accumulated deficit			Total equity
Balance as of January 1, 2023		1,493		582,843		(1,231	)		(430,190	)		152,915


Equity-settled share-based payment awards				9,238								9,238
Loss for the period									(85,733	)		(85,733	)


Balance as of September 30, 2023		1,493		592,081		(1,231	)		(515,923	)		76,420


Balance as of January 1, 2024		1,500		593,666		(1,231	)		(536,128	)		57,807


Issue of common shares		139		6,881								7,020
Equity-settled share-based payment awards				2,133								2,133
Loss for the period									(49,765	)		(49,765	)


Balance as of September 30, 2024		1,639		602,680		(1,231	)		(585,893	)		17,195

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