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 June, 2022
Commission File Number: 001-36619
Affimed N.V.
Im Neuenheimer Feld 582,
69120 Heidelberg,
Germany
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F
☒ Form 20-F ☐ Form 40-F
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INCORPORATION BY REFERENCE
Exhibits 99.1 and 99.2 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration Number 333-227933), Form F-3 (Registration Number 333-251658), Form F-3 (Registration Number 333-260946) and Form S-8 (Registration Numbers 333-198812) of Affimed N.V. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibit 99.3 to this Report on Form 6-K shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 (the Exchange Act) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, in Heidelberg, Germany, June 1, 2022.
AFFIMED N.V. | ||
By: | /s/ Adi Hoess | |
Name: Adi Hoess | ||
Title: Chief Executive Officer | ||
By: | /s/ Angus Smith | |
Name: Angus Smith | ||
Title: Chief Financial Officer |
EXHIBIT INDEX
Exhibit 99.1
Affimed N.V.
Unaudited consolidated statements of comprehensive income / (loss)
(in thousand)
For the three months ended | ||||||||||||
March 31 | ||||||||||||
Note | 2022 | 2021 | ||||||||||
Revenue |
3 | 8,006 | 11,659 | |||||||||
Other income net |
284 | 147 | ||||||||||
Research and development expenses |
(18,379 | ) | (11,405 | ) | ||||||||
General and administrative expenses |
(7,045 | ) | (4,486 | ) | ||||||||
|
|
|
|
|||||||||
Operating income / (loss) |
(17,134 | ) | (4,085 | ) | ||||||||
Finance income / (costs) net |
4 | 471 | 5,499 | |||||||||
|
|
|
|
|||||||||
Income / (loss) before tax |
(16,663 | ) | 1,414 | |||||||||
Income taxes |
(2 | ) | (2 | ) | ||||||||
|
|
|
|
|||||||||
Income / (loss) for the period |
(16,665 | ) | 1,412 | |||||||||
|
|
|
|
|||||||||
Other comprehensive income / (loss) |
||||||||||||
Items that will not be reclassified to profit or loss |
||||||||||||
Equity investments at fair value OCI - net change in fair value |
5 | (6,174 | ) | (1,253 | ) | |||||||
|
|
|
|
|||||||||
Other comprehensive income / (loss) |
(6,174 | ) | (1,253 | ) | ||||||||
Total comprehensive income / (loss) |
(22,839 | ) | 159 | |||||||||
|
|
|
|
|||||||||
Basic and diluted earnings / (loss) per share in per share |
(0.14 | ) | 0.01 | |||||||||
(undiluted = diluted) |
||||||||||||
Weighted number of common shares outstanding |
123,444,217 | 116,204,455 |
The notes are an integral part of these condensed consolidated interim financial statements.
Affimed N.V.
Consolidated statements of financial position
(in thousand)
Note | March 31, 2022 | December 31, 2021 |
||||||||||
(unaudited) | ||||||||||||
ASSETS |
||||||||||||
Non-current assets |
||||||||||||
Intangible assets |
1,580 | 1,607 | ||||||||||
Leasehold improvements and equipment |
3,754 | 3,814 | ||||||||||
Long-term financial assets |
5 | 6,174 | 12,348 | |||||||||
Right-of-use assets |
813 | 972 | ||||||||||
|
|
|
|
|||||||||
12,321 | 18,741 | |||||||||||
Current assets |
||||||||||||
Cash and cash equivalents |
169,850 | 197,630 | ||||||||||
Trade and other receivables |
6 | 4,547 | 4,809 | |||||||||
Inventories |
485 | 421 | ||||||||||
Other assets and prepaid expenses |
7 | 6,048 | 3,534 | |||||||||
|
|
|
|
|||||||||
180,930 | 206,394 | |||||||||||
TOTAL ASSETS |
193,251 | 225,135 | ||||||||||
EQUITY AND LIABILITIES |
||||||||||||
Equity |
||||||||||||
Issued capital |
1,234 | 1,234 | ||||||||||
Capital reserves |
478,395 | 474,087 | ||||||||||
Fair value reserves |
(12,147 | ) | (5,973 | ) | ||||||||
Accumulated deficit |
(350,062 | ) | (333,397 | ) | ||||||||
|
|
|
|
|||||||||
Total equity |
8 | 117,420 | 135,951 | |||||||||
Non-current liabilities |
||||||||||||
Borrowings |
10 | 15,713 | 17,060 | |||||||||
Contract liabilities |
3 | 2,035 | 7,209 | |||||||||
Lease liabilities |
288 | 368 | ||||||||||
|
|
|
|
|||||||||
Total non-current liabilities |
18,036 | 24,637 | ||||||||||
Current liabilities |
||||||||||||
Trade and other payables |
13,537 | 18,860 | ||||||||||
Borrowings |
10 | 2,039 | 580 | |||||||||
Lease liabilities |
592 | 683 | ||||||||||
Contract liabilities |
3 | 41,627 | 44,424 | |||||||||
|
|
|
|
|||||||||
Total current liabilities |
57,795 | 64,547 | ||||||||||
TOTAL EQUITY AND LIABILITIES |
193,251 | 225,135 |
The notes are an integral part of these condensed consolidated interim financial statements.
Affimed N.V.
Unaudited consolidated statements of cash flows (in thousand)
(in thousand)
For the three months ended | ||||||||||||
March 31 | ||||||||||||
Note | 2022 | 2021 | ||||||||||
Cash flow from operating activities |
||||||||||||
Income / (loss) for the period |
(16,665 | ) | 1,412 | |||||||||
Adjustments for the period: |
||||||||||||
- Income taxes |
2 | 2 | ||||||||||
- Depreciation and amortization |
352 | 331 | ||||||||||
- Share-based payments |
9 | 4,247 | 1,109 | |||||||||
- Finance income / costs net |
4 | (471 | ) | (5,499 | ) | |||||||
|
|
|
|
|||||||||
(12,535 | ) | (2,645 | ) | |||||||||
Change in trade and other receivables |
262 | (1,735 | ) | |||||||||
Change in inventories |
(64 | ) | (189 | ) | ||||||||
Change in other assets and prepaid expenses |
(2,435 | ) | 411 | |||||||||
Change in trade, other payables, provisions and contract liabilities |
(13,336 | ) | (11,822 | ) | ||||||||
|
|
|
|
|||||||||
(28,108 | ) | (15,980 | ) | |||||||||
Interest received |
27 | 0 | ||||||||||
Paid interest |
(337 | ) | (50 | ) | ||||||||
Paid income tax |
(2 | ) | (2 | ) | ||||||||
|
|
|
|
|||||||||
Net cash used in operating activities |
(28,420 | ) | (16,032 | ) | ||||||||
Cash flow from investing activities |
||||||||||||
Purchase of intangible assets |
0 | (4 | ) | |||||||||
Purchase of leasehold improvements and equipment |
(106 | ) | (962 | ) | ||||||||
|
|
|
|
|||||||||
Net cash used for investing activities |
(106 | ) | (966 | ) | ||||||||
Cash flow from financing activities |
||||||||||||
Proceeds from issue of common shares, including exercise of share-based payment awards |
|
61 | 101,860 | |||||||||
Transaction costs related to issue of common shares |
(35 | ) | (6,350 | ) | ||||||||
Proceeds from borrowings |
10 | 0 | 10,000 | |||||||||
Transaction costs related to borrowings |
0 | (201 | ) | |||||||||
Repayment of lease liabilities |
(172 | ) | (92 | ) | ||||||||
Repayment of borrowings |
10 | (23 | ) | (23 | ) | |||||||
|
|
|
|
|||||||||
Cash flow from financing activities |
(169 | ) | 105,194 | |||||||||
Exchange rate related changes of cash and cash equivalents |
915 | 5,622 | ||||||||||
Net changes to cash and cash equivalents |
(28,695 | ) | 88,196 | |||||||||
Cash and cash equivalents at the beginning of the period |
197,630 | 146,854 | ||||||||||
|
|
|
|
|||||||||
Cash and cash equivalents at the end of the period |
169,850 | 240,672 | ||||||||||
|
|
|
|
The notes are an integral part of these condensed consolidated interim financial statements.
Affimed N.V.
Unaudited consolidated statements of changes in equity
(in thousand)
Note | Issued capital |
Capital reserves |
Fair value reserves |
Accumulated deficit |
Total equity |
|||||||||||||||||||
Balance as of January 1, 2021 |
983 | 345,164 | 1,720 | (275,874 | ) | 71,993 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Issue of common shares |
204 | 94,215 | 94,419 | |||||||||||||||||||||
Exercise of share-based payment awards |
3 | 1,156 | 1,159 | |||||||||||||||||||||
Equity-settled share-based payment awards |
1,109 | 1,109 | ||||||||||||||||||||||
Income for the period |
1,412 | 1,412 | ||||||||||||||||||||||
Other comprehensive loss |
(1,253 | ) | (1,253 | ) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance as of March 31, 2021 |
1,190 | 441,644 | 467 | (274,462 | ) | 168,839 | ||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance as of January 1, 2022 |
1,234 | 474,087 | (5,973 | ) | (333,397 | ) | 135,951 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Exercise of share-based payment awards |
61 | 61 | ||||||||||||||||||||||
Equity-settled share-based payment awards |
9 | 4,247 | 4,247 | |||||||||||||||||||||
Loss for the period |
(16,665 | ) | (16,665 | ) | ||||||||||||||||||||
Other comprehensive loss |
(6,174 | ) | (6,174 | ) | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||||
Balance as of March 31, 2022 |
1,234 | 478,395 | (12,147 | ) | (350,062 | ) | 117,420 | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
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, AbCheck s.r.o., Plzen, Czech Republic, and Affimed Inc., Delaware, USA (collectively Affimed, the Company or the Group).
Affimed is a clinical-stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies. The Groups product candidates are developed in the field of immuno-oncology, which represents an innovative approach to cancer treatment that seeks to harness the bodys own immune defenses to fight tumor cells. Affimed has its own research and development programs, strategic collaborations and service contracts, where the Group is performing research services for third parties.
2. | Basis of preparation and changes to Groups accounting policies |
Statement of compliance
The condensed consolidated interim financial statements (referred to as interim financial statements) for the three months ended March 31, 2022 and 2021 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, 2021.
The interim financial statements were authorized for issuance by the management board on June 1, 2022.
Loss per share
Loss per common share is calculated by dividing the loss for the period by the weighted average number of common shares outstanding during the period.
As of March 31, 2022, the Group has granted 16,278,740 options and warrants in connection with share-based payment programs (see note 9) and certain loan agreements, 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.
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.
1
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 Companys accounting policies were the same as those that applied to the consolidated financial statements as of and for the year ended December 31, 2021.
Functional and presentation currency
These interim financial statements are presented in Euro. The functional currency of the Groups subsidiaries is also the Euro. All financial information presented in Euro has been rounded to the nearest thousand (abbreviated ) or million (abbreviated million).
Significant accounting policies
The accounting policies applied by the Group in these interim financial statements are the same as those applied by the Group in its consolidated financial statements as of and for the year ended December 31, 2021.
New standards and amendments to standards
The following new standards and amendments to standards have not been applied in preparing these interim financial statements.
Standard/interpretation | Effective Date1 | |
Amendments to IAS 1 Presentation of Financial Statements: | ||
Classification of Liabilities as Current or Non-current | January 1, 2023 | |
Amendments to IAS 1 Presentation of Financial Statements and IFRS Practice Statement 2: Disclosure of Accounting policies | January 1, 2023 | |
Amendments to IAS 8 Accounting policies, Changes in Accounting | ||
Estimates and Errors: Definition of Accounting Estimates | January 1, 2023 | |
Amendments to IAS 12 Income Taxes: Deferred Tax related to Assets and Liabilities arising from a Single Transaction | January 1, 2023 |
The amended standards are not expected to have a significant effect on the interim financial statements of the Group.
1 | Shall apply for periods beginning on or after the date shown in the effective date column. |
2
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, certificates of deposit, cash and cash equivalents, trade and other payables and loans is a reasonable approximation of the fair value and, therefore, information about the fair values of those financial instruments has not been disclosed. The measurement of the fair value of preferred and common shares in other companies held by the group is based on level 1 and 3 inputs (see note 5). The Group recognises transfers between levels of the fair value hierarchy as at the date at which the change has occurred.
3. | Revenue |
Collaboration with Genentech Inc.
In August 2018, Affimed entered into a strategic collaboration agreement with Genentech Inc. (Genentech), headquartered in South San Francisco, USA. Under the terms of the agreement, Affimed is providing services related to the development of novel NK cell engager-based immunotherapeutics to treat multiple cancers. The Genentech agreement became effective at the beginning of October 2018. Under the terms of the agreement, Affimed received $96.0 million (83.2 million) in initial upfront and committed funding on October 31, 2018.
The Group recognized 3.9 million and 8.4 million as revenue during the three months ended March 31, 2022 and 2021, respectively. As of March 31, 2022, contract liabilities of 16.3 million (December 31, 2021: 20.2 million) will be recognized as revenue in subsequent periods as services are provided.
Under the terms of the agreement, Affimed is eligible to receive up to an additional $5.0 billion over time, including payments upon achievement of specified development, regulatory and commercial milestones. Affimed is also eligible to receive royalties on any potential sales.
Collaboration with Roivant Sciences Ltd.
On November 9, 2020, Affimed and Pharmavant 6 GmbH, a subsidiary of Roivant Sciences Ltd. (Roivant), announced a strategic collaboration agreement which grants Roivant a license to the preclinical molecule AFM32. Under the terms of the agreement, Affimed received $60 million in upfront consideration, comprised of $40 million in cash and pre-funded research and development funding, and $20 million of common shares in Roivant. Affimed is eligible to receive additional proceeds in the form of option fees contingent on the commencement of additional programs contemplated under the agreement. The Company is eligible to receive up to an additional $2 billion in milestones over time upon achievement of specified development, regulatory and commercial milestones, as well as tiered royalties on net sales.
3
The Group recognized 3.9 million and 3.0 million as revenue during the three months ended March 31, 2022 and 2021,
respectively. As of March 31, 2022, contract liabilities of 27.4 million (December 31, 2021: 31.3 million) will be recognized as revenue in subsequent periods as services are provided.
Research service agreements
The Group has entered into certain research service agreements. These research service agreements provide for non-refundable upfront technology access research funding or capacity reservation fees and milestone payments. The Group recognized 0.1 million as revenue in the three months ended March 31, 2022 (2021: 0.3 million).
Contract balances
The following table provides information about receivables and contract liabilities from contracts with customers.
March 31, 2022 | December 31, 2021 | |||||||
Receivables |
25 | 150 | ||||||
Contract liabilities |
43,662 | 51,633 |
An amount of 8.0 million recognized in contract liabilities at the beginning of the period has been recognized as revenue during the three months ended March 31, 2022.
The remaining performance obligations as of March 31, 2022 are approximately 43.7 million and are expected to be largely recognized as revenue over the next 12 months (41.7 million), with a smaller portion being realized the 12 months thereafter (2.0 million).
Disaggregation of revenue
Three months ended March 31, 2022 |
Three months ended March 31, 2021 |
|||||||
Geographic information |
||||||||
Revenue: |
||||||||
Germany |
137 | 236 | ||||||
USA |
7,869 | 11,423 | ||||||
8,006 | 11,659 | |||||||
Major service lines: |
||||||||
Collaboration revenue |
7,869 | 11,403 | ||||||
Service revenue |
137 | 256 | ||||||
8,006 | 11,659 | |||||||
Timing on revenue recognition: |
||||||||
Point in time |
0 | 60 | ||||||
Over time |
8,006 | 11,599 | ||||||
8,006 | 11,659 |
4
4. | Finance income and finance costs |
Three months ended March 31, 2022 |
Three months ended March 31, 2021 |
|||||||
Interest SVB Loan Agreement |
(378 | ) | (73 | ) | ||||
Foreign exchange differences |
915 | 5,622 | ||||||
Other finance income/finance costs - net |
(66 | ) | (50 | ) | ||||
471 | 5,499 |
5. | Long-term financial assets |
The Group holds preferred shares in Amphivena, which are currently recognized at their fair value of nil. The impairment of the asset was recognized in 2021 based on the decision made by the Board of Amphivena to wind down the company. Based on current information, we continue to estimate that the fair value remains at nil (December 31, 2021: nil).
The Group also holds common shares in Roivant at their fair value of 6.2 million (December 31, 2021: 12.3 million). During the three months ended March 31, 2022 the fair value decreased by 6.2 million due to a decline in the quoted market price for Roivants common shares, and this decline has been recognized in other comprehensive income. During the three months ended March 31, 2021 the fair value decreased by 1.4 million.
6. | Trade and other receivables |
The trade receivables as of March 31, 2022, were 25 (December 31, 2021: 150), these are all due in the short-term, do not bear interest and are not impaired. Other receivables are all due within the short-term and mainly comprise value-added tax receivables of 3.6 million (December 31, 2021: 2.7 million).
7. | Other assets and prepaid expenses |
The other assets and prepaid expenses as of March 31, 2022 of 6.0 million (December 31, 2021: 3.5 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 2.5 million (December 31, 2021: 2.9 million) for the reservation of manufacturing capacity and a Directors and Officers liability insurance premium of 2.2 million (December 31, 2021: 0 million).
8. | Equity |
As of March 31, 2022, the share capital of 1,234 (December 31, 2021: 1,234) is comprised of 123,445,341 (December 31, 2021: 123,419,772) common shares with a par value of 0.01 per share.
In November 2021, the Company entered into an agreement for a new at-the-market (ATM) program providing for the sales over time of up to $100 million of its common shares.
5
9. | Share-based payments |
In 2014, an equity-settled share-based payment program was established by Affimed N.V. (ESOP 2014). Under this program, the Company granted awards to certain members of the Management Board, the Supervisory Board, non-employee consultants and employees.
Share-based payments with service condition
The majority of the awards vest in instalments over three years and can be exercised up to 10 years after the grant date. The Group granted 4,282,600 awards in the three months ended March 31, 2022 to employees, members of the Management Board and the Supervisory Board. Fair value of the awards at grant date amounts to 12.7 million ($14.2 million). 85,665 ESOP 2014 awards were cancelled or forfeited and 24,446 options were exercised at a weighted-average share price of $2.73. As of March 31, 2022, 14,847,490 (December 31, 2021: 10,675,001) ESOP 2014 options were outstanding, and 6,710,711 awards (December 31, 2021: 5,422,591) had vested. The options outstanding as of March 31, 2022 had an exercise price in the range of $1.30 to $13.47 and a weighted average remaining contractual life of 8.1 years (December 31, 2021: 7.7 years) and a weighted average exercise price of $4.98.
Share-based payments with market condition
On March 30, 2022, the Company issued 1,325,000 options with market-based performance conditions to members of the Management Board. Each grant consists of three tranches, whereby one-third of the total grant will vest when the volume-weighted average share price over the preceding thirty trading days reaches $12.00, $15.00, and $18.00, respectively. Except with respect to a change of control, these options shall not vest before the first anniversary of the grant date. Fair value of the awards at grant date amounts to 1.3 million ($1.4 million) and the contractual life time of the options is two years. Any unvested awards on the date that is two years following the grant date will be cancelled.
Share-based payment expense
In the three months ended March 31, 2022, compensation expense of 4,247 was recognized affecting research and development expenses (2,305) and general and administrative expenses (1,942). In the three months ended March 31, 2021, compensation expense of 1,109 was recognized affecting research and development expenses (469) and general and administrative expenses (640).
Fair value measurement
The fair value of options with service conditions was determined using the Black-Scholes-Merton valuation model. The significant inputs into the valuation model are as follows (weighted average):
March 31, 2022 | March 31, 2021 | |||||||
Fair value at grant date |
$ | 3.32 | $ | 6.77 | ||||
Share price at grant date |
$ | 4.47 | $ | 8.44 | ||||
Exercise price |
$ | 4.47 | $ | 8.44 | ||||
Expected volatility |
90 | % | 95 | % | ||||
Expected life |
5.87 | 5.86 | ||||||
Expected dividends |
0.00 | 0.00 | ||||||
Risk-free interest rate |
2.18 | % | 1.12 | % |
6
The fair value of options with market conditions was determined using a Monte Carlo simulation. The significant inputs into the valuation model are as follows (weighted average):
March 31, 2022 | ||||
Fair value at grant date |
$ | 1.06 | ||
Share price at grant date |
$ | 4.45 | ||
Exercise price |
$ | 4.45 | ||
Expected volatility |
70 | % | ||
Expected life |
2.00 | |||
Expected dividends |
0.00 | |||
Risk-free interest rate |
2.30 | % |
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.
10. | Borrowings |
Silicon Valley Bank
In January 2021, the Group entered into a new loan agreement with Silicon Valley Bank German Branch (SVB) which provides Affimed with up to 25 million in term loans in three tranches: 10 million available at closing, an additional 7.5 million upon the achievement of certain conditions, including milestones related to Affimeds pipeline and market capitalization, and a third tranche of 7.5 million upon the achievement of certain additional conditions related to Affimeds pipeline and liquidity. The first tranche of 10 million was drawn in February 2021 and the second tranche of 7.5 million in December 2021. Pursuant to the terms of the agreement, the loans will bear interest at the greater of the European Central Bank Base Rate and 0%, plus 5.5%, and Affimed is entitled to make interest only payments through December 1, 2022, or June 1, 2023 if Affimed draws on the third tranche of the loans. The loans will mature at the end of November 2025. As of March 31, 2022, the fair value of the liability did not differ significantly from its carrying amount (17.5 million).
7
The loan is secured by a pledge of 100% of the Groups ownership interest in Affimed GmbH, all intercompany claims owed to Affimed N.V. by its subsidiaries, and collateral agreements for all bank accounts, inventory, trade receivables and other receivables of Affimed N.V. and Affimed GmbH recognized in the interim financial statements.
UniCredit Leasing CZ
In April 2019, the Group entered into a loan agreement with UniCredit Leasing CZ for 562. After an initial instalment of 127 in the second quarter of 2019, repayment is effected in monthly instalments of 8 until May 2024. As of March 31, 2022, an amount of 207 (December 31, 2021: 231) was outstanding, of which 95 was classified as current liabilities (December 31, 2021: 94). As of March 31, 2022, the fair value of the liability did not differ significantly from its carrying amount.
11. | Related parties |
The supervisory directors of Affimed N.V. received compensation for their services on the Supervisory Board of 109 (98) in the three months ended March 31, 2022 (2021), remuneration of managing directors and other key management personnel amounted to 893 (877).
The Company recognized share-based payment expenses of 279 (108) for supervisory directors and 1,570 (647) for managing directors and other key management personnel in the three months ended March 31, 2022 (2021).
The following table provides the total amounts of outstanding balances for supervisory board compensation and expense reimbursement related to key management personnel:
Outstanding balances | ||||||||||||
March 31, 2022 | December 31, 2021 | |||||||||||
Adi Hoess |
|
0 | 5 | |||||||||
Thomas Hecht |
|
19 | 19 | |||||||||
Mathieu Simon |
|
7 | 8 | |||||||||
Ferdinand Verdonck 1 |
|
0 | (1 | ) | ||||||||
Ulrich Grau |
|
15 | 16 | |||||||||
Bernhard Ehmer |
|
20 | 20 | |||||||||
Harry Welten |
|
11 | 10 | |||||||||
Annalisa Jenkins |
|
8 | 9 | |||||||||
Uta Kemmerich-Keil |
17 | 19 |
1 | left the Supervisory Board in June 2021. |
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12. | Subsequent events |
The average quoted share price of our investment in Roivant (refer note 5) for the week ended May 20, 2022 was $3.66. This results in a decline in the fair value of the investment by 1.4 million.
On April 18, 2022, the Company closed its public offering of 22,500,000 common shares, at the public offering price of $4.00 per share. The exercise of the underwriters option to purchase over-allotment shares brought the total number of common shares sold by Affimed to 25,875,000 and increased the gross proceeds raised in the offering, before deducting underwriting discounts and commissions and estimated expenses, to $103.5 million (93.2 million).
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Exhibit 99.2
AFFIMED N.V.
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This managements 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-month periods ended March 31, 2022 and 2021 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 2021, and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2021 (the Annual Report) filed with the U.S. Securities and Exchange Commission (the SEC).
Unless otherwise indicated or the context otherwise requires, all references to Affimed or the company, we, our, ours, us or similar terms refer to Affimed N.V. and its subsidiaries.
We prepare and report our consolidated financial statements and financial information in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (the IASB). None of our financial statements were prepared in accordance with generally accepted accounting principles in the United States. We maintain our books and records in euros. We have made rounding adjustments to some of the figures included in this managements discussion and analysis. Accordingly, numerical figures shown as totals in some tables may not be an arithmetic aggregation of the figures that precede them. Unless otherwise indicated, all references to currency amounts in this discussions and analysis are in euros.
Overview
We are a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. Our product candidates represent an innovative approach to cancer treatment that seeks to harness the bodys own immune defenses to fight tumor cells. One of the most potent cells of the human defense arsenal are types of white blood cells called innate immune cells (Natural Killer cells, or NK cells, and macrophages). Leveraging our fit-for-purpose ROCK® (Redirected Optimized Cell Killing) platform, we develop proprietary, next-generation bispecific antibodies, so-called innate cell engagers, which are designed to direct innate immune cells and establish a bridge to cancer cells. Our innate cell engagers have the ability to bring innate immune cells into the proximity of tumor cells and trigger a signal cascade that leads to the destruction of cancer cells. Due to their novel tetravalent architecture with four binding domains, our innate cell engagers bind to their targets with high affinity and have half-lives that allow for regular intravenous administration. Different dosing schemes are being explored to allow for improved exposure in relapsed and refractory cancer patient populations. Based on their mechanism of action as well as the preclinical and clinical data we have generated to date, we believe that our product candidates as monotherapy or in combination, may ultimately improve response rates, clinical outcomes and survival in cancer patients, and could eventually become a cornerstone of modern targeted oncology care. Building on our leadership in the innate cell engager space, we are also developing novel antibody formats with the potential to tailor innate cell-engaging therapy to different indications and settings.
To date, we have financed our operations primarily through our public offerings of our common shares, private placements of equity securities, the incurrence of loans including convertible loans and through government grants and payments for collaborative research and development services. Through March 31, 2022, we have raised an aggregate of approximately 475 million (gross proceeds) through the issuance of equity and incurrence of loans. To date, we have not generated any revenues from product sales or royalties. Based on our current plans, we do not expect to generate product or royalty revenues unless and until we or any collaboration partner obtain marketing approval for, and commercialize, any of our product candidates.
We have generated losses since we began our drug development operations in 2000. As of March 31, 2022, we had an accumulated deficit of 350.1 million.
Notwithstanding our collaborations with Genentech and Roivant, we expect to continue incurring losses as we continue our preclinical and clinical development programs, apply for marketing approval for our product candidates and, subject to obtaining regulatory approval for our product candidates, build a marketing and sales team to commercialize our product candidates. Our profitability is dependent upon the successful development, approval, and commercialization of our product candidates and achieving a level of revenues adequate to support our cost structure. We may never achieve profitability, and unless and until we do, we will continue to need to raise additional capital. We intend to fund future operations through additional equity and debt financings, and we may seek additional capital through arrangements with strategic partners or from other sources.
In 2009, we formed AbCheck, our 100% owned, independently run antibody screening platform company, located in the Czech Republic. AbCheck is devoted to the generation and optimization of fully human antibodies. Its technologies include a naïve human antibody library combined with a phage and yeast display antibody library, a proprietary algorithm to optimize affinity, stability and manufacturing efficiency and a mass humanization technology to discover and optimize high-quality human antibodies. In addition to
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providing candidates for Affimed projects, AbCheck is recognized for its expertise in antibody discovery throughout the United States and Europe and has been working with globally active pharmaceutical and biotechnology companies such as Tusk Therapeutics, bluebird bio, Eli Lilly, Daiichi Sankyo, Pierre Fabre and others.
We have one U.S. subsidiary, Affimed Inc., with senior employees in finance, investor relations, business development, corporate strategy and clinical operations.
Recent Developments
On January 6, 2022, the Company announced the completion of enrollment in the REDIRECT study for AFM13 in patients with relapsed refractory peripheral T-cell lymphoma. A topline clinical readout is expected in the second half of 2022.
On April 10, 2022, the Company announced updated data from the phase 1/2 trial investigating cord blood-derived NK cells pre-complexed with AFM13. For the 13 patients treated at the RP2D, the response rate after two cycles of treatment remained 100% with a 62% complete response rate. Treatment was well tolerated; no instances of cytokine release syndrome, immune effector cell-associated neurotoxicity or graft versus host disease were observed.
On April 18, 2022, the Company closed its public offering of 22,500,000 common shares, at the public offering price of $4.00 per share, and the exercise in full by the underwriters of their option to purchase an additional 3,375,000 common shares. The exercise of the option to purchase over-allotment shares brought the total number of common shares sold by Affimed to 25,875,000 common shares and increased the gross proceeds raised in the offering, before deducting underwriting discounts and commissions and estimated expenses, to $103.5 million.
Collaboration and License Agreements
There have been no material changes to our license agreements from those reported in Item 4. Information on the CompanyB. Business OverviewCollaborations in the Annual Report.
Research and Development Expense
We will use our existing liquidity primarily to fund research and development expense. Our research and development expense is highly dependent on the development phases of our research projects and therefore fluctuates highly from period to period. Our research and development expense mainly relates to the following key programs:
| AFM13. The following is a summary of completed and ongoing research and development activities for AFM13: |
| In April 2022, the Company announced updated data from the phase 1/2 trial investigating cord blood-derived NK cells pre-complexed with AFM13. For the 13 patients treated at the RP2D, the response rate after two cycles of treatment remained at 100% with a 62% complete response rate. Treatment was well tolerated and no instances of cytokine release syndrome, immune effector cell-associated neurotoxicity or graft versus host disease were observed. |
| In September 2020, a phase 1 clinical study was initiated in collaboration with the University of Texas MD Anderson Cancer Center (MDACC), in which MDACC is investigating the combination of AFM13 with allogeneic NK cells. MDACC is administering a stable complex of AFM13 pre-complexed with cord blood-derived allogeneic NK cells in different doses (numbers of pre-complexed NK cells) into patients with relapsed/refractory CD30-positive lymphoid malignancies. |
| In November 2019, we initiated a registration directed phase 2 study of AFM13 as monotherapy in relapsed or refractory patients suffering from peripheral T cell lymphoma (PTCL). In March 2021, we announced a positive pre-planned interim futility analysis for the study. In January 2022, we completed enrollment of the study and expect to release topline results in the fourth quarter of 2022. |
| We anticipate that our research and development expenses in 2022 for AFM13 will increase compared to 2021 due to the continuation of certain clinical and pre-clinical studies and upscaling the production of AFM13 for commercial purposes. |
| AFM24. AFM24, a tetravalent, bispecific epidermal growth factor receptor, and CD16A-binding innate cell engager, is currently enrolling three phase 1/2a clinical trials in patients with advanced cancers known to express EGFR. We have initiated enrollment |
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in the expansion phase of the monotherapy AFM24 trial and also initiated enrollment in two separate phase 1/2a combination studies. As a result, we anticipate that our research and development expenses in 2022 for AFM24 will increase compared to those in 2021. |
| AFM28. AFM28 is designed to bind to CD123, an established target in myeloid malignancies. We chose CD123 as it is almost universally expressed on leukemic blasts and leukemic stem cells in patients with AML, both at diagnosis and at relapse, and independently of cytogenetic risk. AFM28 is being developed for the treatment of patients with acute myeloid leukemia. AFM28 is currently in preclinical development, and we expect to file an IND application with the FDA in June 2022. |
| Other projects and infrastructure costs. Our other research and development expenses relate to our Genentech, Roivant and Artiva collaborations, and early-stage development/discovery activities. We have allocated a material amount of our resources to such discovery activities. The expenses mainly consist of salaries, manufacturing costs for pre-clinical study material and pre-clinical studies. In addition, we incur a significant amount of costs associated with our research and development that are non-project specific, including intellectual property-related expenses, depreciation expenses and facility costs. Because these are less dependent on individual ongoing programs, they are not allocated to specific projects. We assume that other projects and infrastructure costs will increase in 2022 due to increased early-stage development/discovery activities. |
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Results of Operations
The financial information shown below was derived from our unaudited interim consolidated financial statements for the three month periods ended March 31, 2022 and 2021. The discussion below should be read along with these financial statements, and it is qualified in its entirety by reference to them.
Comparison of the three months ended March 31, 2022 and 2021
Three months ended March 31, |
||||||||
2022 | 2021 | |||||||
(unaudited) | ||||||||
(in thousand) | ||||||||
Total Revenue |
8,006 | 11,659 | ||||||
Other income (expenses)net |
284 | 147 | ||||||
Research and development expenses |
(18,379 | ) | (11,405 | ) | ||||
General and administrative expenses |
(7,045 | ) | (4,486 | ) | ||||
Operating loss |
(17,134 | ) | (4,085 | ) | ||||
Finance income/(costs)net |
471 | 5,499 | ||||||
Income/(loss) before tax |
(16,663 | ) | 1,414 | |||||
Income taxes |
(2 | ) | (2 | ) | ||||
Income/(loss) for the period |
(16,665 | ) | 1,412 | |||||
Other comprehensive income/(loss) |
(6,174 | ) | (1,253 | ) | ||||
Total comprehensive income/(loss) |
(22,839 | ) | 159 | |||||
Earnings/(loss) per common share in per share (undiluted) |
(0.14 | ) | 0.01 | |||||
Earnings/(loss) per common share in per share (diluted) |
(0.14 | ) | 0.01 |
Revenue
Revenue decreased to 8.0 million in the three months ended March 31, 2022 from 11.7 million for the three months ended March 31, 2021. Revenue in the three months ended March 31, 2022 and 2021 predominantly relate to the Genentech and Roivant collaborations with 3.9 million, (2021: 8.4 million) and 3.9 million (2021: 3.0 million) respectively. Revenue from the Genentech and Roivant collaborations in the three months ended March 31, 2022 was comprised of revenue recognized for collaborative research services performed during the quarter. We expect the Genentech collaboration revenue to decline in 2022 compared to 2021, as certain projects come to an end.
Research and development expenses
Three months ended March 31 | ||||||||||||
2022 | 2021 | Change % | ||||||||||
Unaudited | ||||||||||||
R&D Expenses by Project | (in thousand) | |||||||||||
Project |
||||||||||||
AFM13 |
2,022 | 2,450 | (17 | %) | ||||||||
AFM24 |
4,163 | 2,589 | 61 | % | ||||||||
AFM28 |
2,707 | 496 | 445 | % | ||||||||
Other projects and infrastructure costs |
7,183 | 5,401 | 33 | % | ||||||||
Share-based payment expense |
2,304 | 469 | 391 | % | ||||||||
Total |
18,379 | 11,405 | 61 | % |
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Research and development expenses amounted to 18.4 million in the three months ended March 31, 2022 compared to research and development expenses of 11.4 million in the three months ended March 31, 2021. The variances in project-related expenses between the projects for the three months ended March 31, 2022 and the corresponding period in 2021 are mainly due to the following:
| AFM13. In the three months ended March 31, 2022 we incurred lower expenses (17%) than in the three months ended March 31, 2021 primarily due to lower expenses for the procurement of clinical trial material. |
| AFM24. In the three months ended March 31, 2022, we incurred higher expenses (61%) than in the three months ended March 31, 2021 due to the continued enrollment of patients in our ongoing phase 1/2a clinical trials and for the procurement of clinical trial material. |
| AFM28. In the three months ended March 31, 2022, we incurred higher expenses (445%) than in the three months ended March 31, 2021 due to preclinical development as we prepare to file an IND application with the FDA. |
| Other projects and infrastructure costs. In the three months ended March 31, 2022, expenses were higher (33%) than in the three months ended March 31, 2021 primarily due to higher expenses incurred in relation to our earlier stage programs, including our collaborations with Genentech and Roivant, and discovery/early stage development activities and infrastructure costs. |
General and administrative expenses
General and administrative expenses amounted to 7.0 million in the three months ended March 31, 2022 compared to 4.5 million in the three months ended March 31, 2021. The increase is mainly due to higher personnel expenses, higher insurance fees for D&O insurance coverage, higher share-based payment expenses and higher consulting costs.
Finance income / (costs)-net
Finance income for the three months ended March 31, 2022 totaled 0.5 million, compared to 5.5 million for the three months ended March 31, 2021. Finance income in the three months ended March 31, 2022 and 2021 primarily made up of foreign exchange gains related to cash and cash equivalents denominated in U.S. dollars as a result of the strengthening of the U.S. dollar compared to the Euro.
Other comprehensive income/(loss)
The Group holds common shares in Roivant at their fair value of 6.2 million (December 31, 2021: 12.3 million). During the three months ended March 31, 2022 the fair value decreased by 6.2 million due to a decline of the quoted market price for Roivants common shares, and this decline has been recognized in other comprehensive income/(loss).
Liquidity and Capital Resources
Since inception, we have not generated any revenue from product sales and we have incurred significant operating losses. We have funded our operations to date primarily through our public offerings of our common shares, private placements of equity securities and loans, grants and payments from collaboration partners.
5
Cash flows
The table below summarizes our consolidated statement of cash flows for the three months ended March 31, 2022 and 2021:
Three months ended March 31, |
||||||||
2022 | 2021 | |||||||
(unaudited) (in thousand) |
||||||||
Net cash used in operating activities |
(28,420 | ) | (16,032 | ) | ||||
Net cash used for/generated from investing activities |
(106 | ) | (966 | ) | ||||
Net cash generated from/used in financing activities |
(169 | ) | 105,194 | |||||
Exchange rate related changes of cash and cash equivalents |
915 | 5,622 | ||||||
Net changes to cash and cash equivalents |
(28,695 | ) | 88,196 | |||||
Cash and cash equivalents at the beginning of the period |
197,630 | 146,854 | ||||||
Cash and cash equivalents at the end of the period |
169,850 | 240,672 |
Net cash used in operating activities of 28.4 million in the three months ended March 31, 2022 is higher than net cash used in operating activities in the three months ended March 31, 2021 (16.0 million) mainly due to higher cash expenditure for research and development, including a milestone payment of 6.3 million. The investing activities in the three months ended March 31, 2022 and 2021 primarily related to investment in acquisition of equipment. Net cash used in financing activities in the three months ended March 31, 2022 (0.2 million) resulted primarily from the payment of lease liabilities, while the cash generated in the three months ended March 31, 2021 from financing activities primarily resulted from proceeds of a public equity offering and proceeds from borrowings.
Cash and Funding Sources
Our cash and cash equivalents as of March 31, 2022 were 169.9 million, compared with 197.6 million as of December 31, 2021. Funding sources generally comprise proceeds from the issuance of equity instruments, payments from collaboration agreements and loans.
On April 18, 2022, the Company closed its public offering of 22,500,000 common shares, at the public offering price of $4.00 per share, and the exercise in full by the underwriters of their option to purchase an additional 3,375,000 common shares. The exercise of the option to purchase over-allotment shares brought the total number of common shares sold by Affimed to 25,875,000 common shares and increased the gross proceeds raised in the offering, before deducting underwriting discounts and commissions and estimated expenses, to $103.5 million.
Funding Requirements
We expect that we will require additional funding to complete the development of our product candidates and to continue to advance the development of our other product candidates. In addition, we expect that we will require additional capital to commercialize our product candidates, including AFM13, AFM24 and AFM28. If we receive regulatory approval for AFM13, AFM24, AFM28 or other earlier programs, and if we choose not to grant any licenses to partners, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We also continue to incur substantial costs associated with operating as a public company. Additional funds may not be available on a timely basis, on favorable terms, or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy. If we are not able to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
Based on our current operating and budget assumptions, we believe that our existing liquidity, including the net proceeds received from our public offering in April 2022, will enable us to fund our operating expenses and capital expenditure requirements at least into mid-2024. 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; |
6
| 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 three months ended March 31, 2022, there were no significant changes to our quantitative and qualitative disclosures about market risk from those reported in Item 11. Quantitative and Qualitative Disclosures About Risk in the Annual Report.
Critical Judgments and Accounting Estimates
There have been no material changes to the significant accounting policies and estimates described in Item 5. Operating and Financial Review and ProspectsA. Operating Results OverviewCritical Judgments and Accounting Estimates in the Annual Report.
Recent Accounting Pronouncements
We refer to note 2 of the notes to the unaudited interim consolidated financial statements for the three month periods ended March 31, 2022 and 2021 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 managements 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 March 31, 2022, our accumulated deficit was 350.1 million; |
| the chance our clinical trials may be delayed or put on clinical hold, for example, due to slower than expected enrollment or regulatory actions, or not be successful and clinical results may not reflect results seen in previously conducted preclinical studies and clinical trials, or expectations based on these preclinical studies and clinical trials; |
| our reliance on contract manufacturers and contract research organizations over which we have limited control; |
| our lack of adequate funding to complete development of our product candidates and the risk we may be unable to access additional capital on reasonable terms or at all to complete development and begin commercialization of our product candidates; |
| our dependence on the success of AFM13 and AFM24 (which are still in clinical development) and certain of our other product candidates including AFM28, each of which may eventually prove to be unsuccessful or commercially not exploitable; |
7
| uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; |
| the outcome of any, or any discussions we may enter regarding, acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; |
| the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or in the commercial stage; |
| if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory overview; |
| enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; |
| future legislation may materially impact our ability to realize revenue from any approved and commercialized products; |
| the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; |
| our reliance on our current strategic relationships with NKGen Biotech, Roivant, Artiva, The MD Anderson Cancer Center, and Genentech and the potential failure to enter into new strategic relationships or difficulties with our strategic partners that may slow the progress of our joint developments or lead to the termination of a partnership and the need to enter into a new one, all of which could take substantial time and attention of our management team; |
| our reliance on third parties to conduct our nonclinical and clinical trials and on third-party, single-source suppliers to supply or produce our product candidates; |
| our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization; |
| our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; |
| the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; |
| the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict; and |
| other risk factors discussed under Item 3. Key InformationD. Risk Factors in the Annual Report. |
Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do so, what impact they will have on our results of operations, cash flows or financial condition. Additionally, some of the risks and uncertainties identified above may be amplified by the COVID-19 outbreak. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknown. Except as required by law, we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.
8
Exhibit 99.3
PRESS RELEASE
Affimed Reports First Quarter 2022 Financial Results and
Highlights Recent Operational Progress
| AFM13 monotherapy: Completed enrollment in the REDIRECT study for patients with relapsed or refractory PTCL; on track to report topline data in the fourth quarter of 2022 |
| AFM13 combination with NK cells: Reported data at AACR 2022 showing a 100% objective response rate (ORR) and an increase in complete responses (CR) from 38%, reported in December, to 62% after a second cycle of therapy in 13 patients at the recommended phase 2 dose (RP2D) with encouraging signals on durability |
| AFM24 monotherapy: Completed enrollment of the 720mg cohort; presented data at AACR 2022 and NK2022; data show a plateau in NK cell activation and CD16 receptor binding and confirm 480mg as the RP2D |
| AFM24 combination studies with NK cells and anti PD-L1 checkpoint inhibitor: Continued enrollment of patients in two separate phase 1/2a studies investigating AFM24 in combination with atezolizumab and SNK01 NK cells |
| AFM28 monotherapy: On track for IND filing in relapsed/refractory AML in June 2022; initiation of phase 1 clinical trial expected in the second half of 2022 |
| AFM28 combination with NK cells: Presented a poster of preclinical data at NK2022 demonstrating that AFM28 exhibits greater surface retention than conventional monoclonal antibodies and lysis of CD123-positive tumor cells when pre-complexed or co-administered with cryopreserved NK cells |
| Cash runway into mid-2024 following completion of $103.5 million public offering in April 2022 |
| Conference call and webcast scheduled for June 1, 2022, at 8:30 a.m. EDT / 14:30 CET |
Heidelberg, Germany, June 1, 2022 Affimed N.V. (Nasdaq: AFMD) (Affimed or the Company), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results for the first quarter ended March 31, 2022 and provided an update on clinical and corporate progress.
We are excited about the progress we are making advancing our Innate Cell Engagers (ICE®) including completing enrollment of REDIRECT, our first registration directed study, and establishing a compelling proof of concept for AFM13 combined with NK cells as evidenced by the remarkable clinical data presented at AACR. These results continue to validate our three-pronged development approach and the potential of our ICE® molecules to offer novel treatments for heavily pretreated, relapsed/refractory patients with limited options, said Dr. Adi Hoess, CEO of Affimed. Our strong financial position allows us to maintain our focus on execution so that we can bring these important therapies to patients who need them as soon as possible.
Clinical Stage Program Updates
AFM13 (CD30/CD16A)
| Affimed completed enrollment of its REDIRECT study (AFM13-202). The Company expects to report top-line data in the fourth quarter of 2022. REDIRECT is a phase 2, registration-directed study of AFM13 monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL). |
| At an AACR 2022 Clinical Trials Plenary Session, Dr. Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at MD Anderson, presented follow-up data to the investigator sponsored trial (IST) (AFM13-104) investigating the combination of AFM13 pre-complexed with cord blood-derived natural killer cells followed by AFM13 monotherapy in relapsed/refractory CD30+ lymphomas. The treatment resulted in a 100% ORR with 8/13 (62%) patients achieving a complete response after two cycles of treatment at the RP2D. |
Durability data presented at AACR for patients treated at the RP2D was also promising. As of the cutoff date, of the eight patients who achieved a CR, seven remained in CR at median follow-up of 6.5 months, including two patients who remained in response after 10 months and two who received a consolidation autologous stem cell transplant (SCT).
The safety profile was well managed, with the main treatment related side-effect being infusion related reactions. The investigators did not observe any cases of cytokine release syndrome (CRS), neurotoxicity or graft versus host disease often associated with T-cell therapies. In general, side effects observed in the trial were transient and did not lead to treatment delays or discontinuation.
The recently approved amendment to the AFM13-104 trial protocol allows for an increase in the number of CD30-positive lymphoma patients treated at the RP2D to 40including Hodgkin and non-Hodgkins lymphoma patients. Furthermore, under the amended protocol, patients can receive more than two cycles of treatment.
The Company and MD Anderson expect to report updates on the study at a medical conference in the second half of the 2022.
AFM24 (EGFR/CD16A)
| In the monotherapy phase 1/2a clinical trial (AFM24-101), enrollment in cohort seven of the dose escalation study, which treated patients at the 720mg dose, was completed without dose limiting toxicities. Based on the pharmacokinetic and pharmacodynamic data, and in agreement with the Safety Review Committee (SRC), no further dose escalation is planned. The data confirm the selection of 480mg as the RP2D. |
The Company is continuing enrollment in the expansion phase of the monotherapy study at the RP2D. The expansion cohorts include patients with renal cell carcinoma (clear cell), non-small cell lung cancer (EFGR mutant), and colorectal cancer.
| Enrollment continues in the phase 1/2a combination study of AFM24 with the anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®) (AFM24-102) to treat patients with non-small cell lung cancer (EGFR wildtype), gastric and gastroesophageal junction adenocarcinoma and pancreatic/hepatocellular/biliary tract cancer. |
| Enrollment continues in the phase 1/2a combination study of AFM24 with the SNK01 (ex vivo expanded and activated autologous NK cell therapy from NKGen Biotech) cells (AFM24-103) to treat patients with non-small cell lung cancer (NSCLC, EGFR-wildtype), squamous cell carcinoma of the head and neck, and colorectal cancer. |
| In these studies, the Company is evaluating the safety and efficacy of AFM24 in nine indication-specific cohorts, with a particular focus on NSCLC, which is represented in all three studies, and CRC, represented in two of the three studies. Affimed expects to report initial data from the studies in the second half of 2022. |
| Presented a poster at AACR 2022 including data from dose escalation phase of AFM24-101, highlighting data that informed the selection of 480mg as the RP2D. Presented a poster at NK2022 conference featuring an analysis of the longitudinal effects of AFM24 in patients treated in AFM24-101, confirming the mechanism of action of AFM24 on the innate immune system. |
Preclinical Programs
AFM28 (CD123/CD16A)
| AFM28 is a bispecific, tetravalent ICE® that targets CD16A on NK cells and macrophages, and CD123 on leukemic blasts and leukemic stem cells that are prevalent in acute myeloid leukemia (AML). |
| The Company expects to submit an IND in June and is planning to start clinical investigation of AFM28 in the second half of 2022. |
| At the NK2022 conference, the Company presented preclinical data demonstrating that AFM28 exhibits greater cell surface retention on NK cells than conventional monoclonal antibodies. Furthermore, AFM28 induced lysis of CD123-positive tumor cells when pre-complexed or when co-administered with cryopreserved NK cells, suggesting that AFM28 in combination with NK cells maintains anti-tumor activity, an exciting finding in that it presents the promise for an off-the-shelf therapy targeting leukemic blasts and LSCs in patients with AML. |
Preclinical Pipeline
| Affimed is continuing the generation of several novel ICE® molecules derived from its proprietary ROCK® platform. |
Partnerships and Collaborations
| The Company continues to advance its work with existing partners including MD Anderson, Artiva, and NKGen Biotech to ensure access to an off-the-shelf, cryopreserved NK cell for further development with its ICE® molecules and expects to provide updates on its NK cell development strategy in the second half of 2022. |
| Partnered programs with both Genentech and Roivant continue to progress according to plan, and Affimed is eligible for additional proceeds from meeting pre-clinical and early regulatory achievement milestones. |
First Quarter 2022 Financial Highlights
Affimeds consolidated financial statements are prepared in accordance with IFRS as issued by the International Accounting Standard Board (IASB). The consolidated financial statements are presented in euros, the Companys functional and presentation currency.
As of March 31, 2022, cash and cash equivalents totaled 169.9 million compared to 197.6 million on December 31, 2021. The pro forma cash position as of March 31, 2022, including net proceedsbefore offering expensesfrom the April 2022 underwritten public offering would be approximately 257.5 million.
Based on the Companys current operating plan and assumptions, cash and cash equivalents, including proceeds from the April 2022 public offering, are expected to support operations into mid-2024.
Net cash used in operating activities for the quarter ended March 31, 2022, was 28.4 million compared to 16.0 million for the quarter ended March 31, 2021. Included in the cash burn for the quarter was a milestone payment to MD Anderson for the initiation of the Phase 2 portion of the AFM13-104 trial, which was expensed in Q4 2021 and paid in Q1 2022.
Total revenue for the quarter ended March 31, 2022, was 8.0 million compared with 11.7 million for the quarter ended March 31, 2021. Revenue predominately relates to the Genentech and Roivant collaborations.
Research and development expenses for the quarter ended March 31, 2022, increased by 61% from 11.4 million to 18.4 million compared to the quarter ended March 31, 2021. Research and development expenses increased primarily due to increased expenses associated with the development of the AFM24 and AFM28 programs and included costs to produce clinical trial material, an increase in costs associated with other early-stage programs and infrastructure, and an increase in share-based payment expenses.
General and administrative expenses increased 57% from 4.5 million in the quarter ended March 31, 2021, to 7.0 million in the quarter ended March 31, 2022. The increase predominately relates to higher share-based payment expenses and an increase in insurance premiums.
Net finance income for the quarter ended March 31, 2022, decreased by 91% from 5.5 million in the quarter ended March 31, 2021, to 0.5 million. Net finance income is largely the result of foreign exchange gains related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and Euro during the year.
Net loss for the quarter ended March 31, 2022, was 16.7 million, or 0.14 loss per common share compared with a net income of 1.4 million, or 0.01 earnings per common share, for the quarter ended March 31, 2021.
The weighted number of common shares outstanding for the quarter ended March 31, 2022, was 123.4 million.
Additional information regarding these results is included in the notes to the consolidated financial statements as of March 31, 2022, which will be included in Affimeds filings with the U.S. Securities and Exchange Commission (SEC).
Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.
Conference Call and Webcast Information
Affimed will host a conference call and webcast June 1, 2022, at 8:30 a.m. EDT / 14:30 CET to discuss first quarter 2022 financial results and corporate developments. The conference call will be available via phone and webcast.
To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference passcode 4440407 approximately 15 minutes prior to the call.
A live audio webcast of the conference call will be available in the Webcasts section on the Investors page of the Affimed website at https://www.affimed.com/investors/webcasts-and-corporate-presentation/.
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 Companys proprietary ROCK® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK® platform predictably generates customized innate cell engager (ICE®) molecules, which use patients immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE®. Headquartered in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients lives. For more about the Companys people, pipeline and partners, please visit: www.affimed.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as anticipate, believe, could, estimate, expect, goal, intend, look forward to, may, plan, potential, predict, project, should, will, would and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, AFM28 and our other product candidates, the value of our ROCK® platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict and the risks, uncertainties and other factors described under the heading Risk Factors in Affimeds filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.
Investor Relations Contact
Alexander Fudukidis
Director, Head of Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102
Affimed N.V.
Unaudited consolidated statements of comprehensive income / (loss)
(in thousand)
For the three months ended | ||||||||
March 31 | ||||||||
2022 | 2021 | |||||||
Revenue |
8,006 | 11,659 | ||||||
Other income net |
284 | 147 | ||||||
Research and development expenses |
(18,379 | ) | (11,405 | ) | ||||
General and administrative expenses |
(7,045 | ) | (4,486 | ) | ||||
|
|
|
|
|||||
Operating income / (loss) |
(17,134 | ) | (4,085 | ) | ||||
Finance income / (costs) net |
471 | 5,499 | ||||||
|
|
|
|
|||||
Income / (loss) before tax |
(16,663 | ) | 1,414 | |||||
Income taxes |
(2 | ) | (2 | ) | ||||
|
|
|
|
|||||
Income / (loss) for the period |
(16,665 | ) | 1,412 | |||||
|
|
|
|
|||||
Other comprehensive income / (loss) |
||||||||
Items that will not be reclassified to profit or loss |
||||||||
Equity investments at fair value OCI - net change in fair value |
(6,174 | ) | (1,253 | ) | ||||
|
|
|
|
|||||
Other comprehensive income / (loss) |
(6,174 | ) | (1,253 | ) | ||||
|
|
|
|
|||||
Total comprehensive income / (loss) |
(22,839 | ) | 159 | |||||
|
|
|
|
|||||
Basic and diluted earnings / (loss) per share in per share |
(0.14 | ) | 0.01 | |||||
(undiluted = diluted) |
||||||||
Weighted number of common shares outstanding |
123,444,217 | 116,204,455 |
Affimed N.V.
Consolidated statements of financial position
(in thousand)
March 31, 2022 |
December 31, 2021 |
|||||||
(unaudited) | ||||||||
ASSETS |
||||||||
Non-current assets |
||||||||
Intangible assets |
1,580 | 1,607 | ||||||
Leasehold improvements and equipment |
3,754 | 3,814 | ||||||
Long-term financial assets |
6,174 | 12,348 | ||||||
Right-of-use assets |
813 | 972 | ||||||
|
|
|
|
|||||
12,321 | 18,741 | |||||||
Current assets |
||||||||
Cash and cash equivalents |
169,850 | 197,630 | ||||||
Trade and other receivables |
4,547 | 4,809 | ||||||
Inventories |
485 | 421 | ||||||
Other assets and prepaid expenses |
6,048 | 3,534 | ||||||
|
|
|
|
|||||
180,930 | 206,394 | |||||||
TOTAL ASSETS |
193,251 | 225,135 | ||||||
EQUITY AND LIABILITIES |
||||||||
Equity |
||||||||
Issued capital |
1,234 | 1,234 | ||||||
Capital reserves |
478,395 | 474,087 | ||||||
Fair value reserves |
(12,147 | ) | (5,973 | ) | ||||
Accumulated deficit |
(350,062 | ) | (333,397 | ) | ||||
|
|
|
|
|||||
Total equity |
117,420 | 135,951 | ||||||
Non-current liabilities |
||||||||
Borrowings |
15,713 | 17,060 | ||||||
Contract liabilities |
2,035 | 7,209 | ||||||
Lease liabilities |
288 | 368 | ||||||
|
|
|
|
|||||
Total non-current liabilities |
18,036 | 24,637 | ||||||
Current liabilities |
||||||||
Trade and other payables |
13,537 | 18,860 | ||||||
Borrowings |
2,039 | 580 | ||||||
Lease liabilities |
592 | 683 | ||||||
Contract liabilities |
41,627 | 44,424 | ||||||
|
|
|
|
|||||
Total current liabilities |
57,795 | 64,547 | ||||||
TOTAL EQUITY AND LIABILITIES |
193,251 | 225,135 |
Affimed N.V.
Unaudited consolidated statements of cash flows (in thousand)
(in thousand)
For the three months ended | ||||||||
March 31 | ||||||||
2022 | 2021 | |||||||
Cash flow from operating activities |
||||||||
Income / (loss) for the period |
(16,665 | ) | 1,412 | |||||
Adjustments for the period: |
||||||||
- Income taxes |
2 | 2 | ||||||
- Depreciation and amortization |
352 | 331 | ||||||
- Share-based payments |
4,247 | 1,109 | ||||||
- Finance income / costs net |
(471 | ) | (5,499 | ) | ||||
|
|
|
|
|||||
(12,535 | ) | (2,645 | ) | |||||
Change in trade and other receivables |
262 | (1,735 | ) | |||||
Change in inventories |
(64 | ) | (189 | ) | ||||
Change in other assets and prepaid expenses |
(2,435 | ) | 411 | |||||
Change in trade, other payables, provisions and contract liabilities |
(13,336 | ) | (11,822 | ) | ||||
|
|
|
|
|||||
(28,108 | ) | (15,980 | ) | |||||
Interest received |
27 | 0 | ||||||
Paid interest |
(337 | ) | (50 | ) | ||||
Paid income tax |
(2 | ) | (2 | ) | ||||
|
|
|
|
|||||
Net cash used in operating activities |
(28,420 | ) | (16,032 | ) | ||||
Cash flow from investing activities |
||||||||
Purchase of intangible assets |
0 | (4 | ) | |||||
Purchase of leasehold improvements and equipment |
(106 | ) | (962 | ) | ||||
|
|
|
|
|||||
Net cash used for investing activities |
(106 | ) | (966 | ) | ||||
Cash flow from financing activities |
||||||||
Proceeds from issue of common shares, including exercise of share-based payment awards |
61 | 101,860 | ||||||
Transaction costs related to issue of common shares |
(35 | ) | (6,350 | ) | ||||
Proceeds from borrowings |
0 | 10,000 | ||||||
Transaction costs related to borrowings |
0 | (201 | ) | |||||
Repayment of lease liabilities |
(172 | ) | (92 | ) | ||||
Repayment of borrowings |
(23 | ) | (23 | ) | ||||
|
|
|
|
|||||
Cash flow from financing activities |
(169 | ) | 105,194 | |||||
Exchange rate related changes of cash and cash equivalents |
915 | 5,622 | ||||||
Net changes to cash and cash equivalents |
(28,695 | ) | 88,196 | |||||
Cash and cash equivalents at the beginning of the period |
197,630 | 146,854 | ||||||
|
|
|
|
|||||
Cash and cash equivalents at the end of the period |
169,850 | 240,672 | ||||||
|
|
|
|
Affimed N.V.
Unaudited consolidated statements of changes in equity
(in thousand)
Issued capital |
Capital reserves |
Fair value reserves |
Accumulated deficit |
Total equity |
||||||||||||||||
Balance as of January 1, 2021 |
983 | 345,164 | 1,720 | (275,874 | ) | 71,993 | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Issue of common shares |
204 | 94,215 | 94,419 | |||||||||||||||||
Exercise of share-based payment awards |
3 | 1,156 | 1,159 | |||||||||||||||||
Equity-settled share-based payment awards |
1,109 | 1,109 | ||||||||||||||||||
Income for the period |
1,412 | 1,412 | ||||||||||||||||||
Other comprehensive loss |
(1,253 | ) | (1,253 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balance as of March 31, 2021 |
1,190 | 441,644 | 467 | (274,462 | ) | 168,839 | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balance as of January 1, 2022 |
1,234 | 474,087 | (5,973 | ) | (333,397 | ) | 135,951 | |||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Exercise of share-based payment awards |
61 | 61 | ||||||||||||||||||
Equity-settled share-based payment awards |
4,247 | 4,247 | ||||||||||||||||||
Loss for the period |
(16,665 | ) | (16,665 | ) | ||||||||||||||||
Other comprehensive loss |
(6,174 | ) | (6,174 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balance as of March 31, 2022 |
1,234 | 478,395 | (12,147 | ) | (350,062 | ) | 117,420 | |||||||||||||
|
|
|
|
|
|
|
|
|
|