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, 2020
Commission File Number: 001-36619
Affimed N.V.
Im Neuenheimer Feld 582,
69120 Heidelberg,
Germany
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INCORPORATION BY REFERENCE
Exhibits 99.1 and 99.2 to this Report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form F-3 (Registration Number 333-227933) and Form S-8 (Registration Numbers 333-198812) of Affimed N.V. and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibit 99.3 to this Report on Form 6-K shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 (the Exchange Act) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, in Heidelberg, Germany, June 23, 2020.
AFFIMED N.V. | ||
By: | /s/ Adi Hoess | |
Name: Adi Hoess | ||
Title: Chief Executive Officer | ||
By: | /s/ Wolfgang Fischer | |
Name: Wolfgang Fischer | ||
Title: Chief Operating Officer |
EXHIBIT INDEX
EXHIBIT 99.1
Affimed N.V.
Unaudited consolidated statements of comprehensive income / (loss) (in thousand)
Note | For the three months ended March 31 |
|||||||||||
2020 | 2019 | |||||||||||
Revenue |
3 | 5,135 | 11,353 | |||||||||
Other income net |
(57 | ) | 86 | |||||||||
Research and development expenses |
(11,449 | ) | (7,987 | ) | ||||||||
General and administrative expenses |
(3,525 | ) | (2,434 | ) | ||||||||
|
|
|
|
|||||||||
Operating income / (loss) |
(9,896 | ) | 1,018 | |||||||||
Finance income / (costs) net |
4 | 1,607 | 834 | |||||||||
|
|
|
|
|||||||||
Income / (loss) before tax |
(8,289 | ) | 1,852 | |||||||||
|
|
|
|
|||||||||
Income / (loss) for the period |
(8,289 | ) | 1,852 | |||||||||
|
|
|
|
|||||||||
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 | 81 | 73 | |||||||||
|
|
|
|
|||||||||
Other comprehensive income / (loss) |
81 | 73 | ||||||||||
Total comprehensive income / (loss) |
(8,208 | ) | 1,925 | |||||||||
|
|
|
|
|||||||||
Earnings / (loss) per share in per share (undiluted = diluted) |
(0.11 | ) | 0.03 | |||||||||
Weighted number of common shares outstanding |
76,249,901 | 62,430,106 |
The notes are an integral part of these consolidated financial statements.
Affimed N.V.
Consolidated statements of financial position (in thousand)
Note | March 31, 2020 |
December 31, 2019 |
||||||||||
(unaudited) | ||||||||||||
ASSETS |
||||||||||||
Non-current assets |
||||||||||||
Intangible assets |
121 | 137 | ||||||||||
Leasehold improvements and equipment |
2,193 | 2,291 | ||||||||||
Long term financial assets |
5 | 3,274 | 3,193 | |||||||||
Right-of-use assets |
679 | 824 | ||||||||||
|
|
|
|
|||||||||
6,267 | 6,445 | |||||||||||
Current assets |
||||||||||||
Cash and cash equivalents |
82,765 | 95,234 | ||||||||||
Financial assets |
6 | 5,476 | 8,902 | |||||||||
Trade and other receivables |
2,171 | 1,482 | ||||||||||
Inventories |
337 | 296 | ||||||||||
|
|
|
|
|||||||||
90,749 | 105,914 | |||||||||||
TOTAL ASSETS |
97,016 | 112,359 | ||||||||||
EQUITY AND LIABILITIES |
||||||||||||
Equity |
||||||||||||
Issued capital |
762 | 762 | ||||||||||
Capital reserves |
271,178 | 270,451 | ||||||||||
Fair value reserves |
2,043 | 1,962 | ||||||||||
Accumulated deficit |
(242,797 | ) | (234,508 | ) | ||||||||
|
|
|
|
|||||||||
Total equity |
7 | 31,186 | 38,667 | |||||||||
Non-current liabilities |
||||||||||||
Borrowings |
10 | 254 | 278 | |||||||||
Contract liabilities |
30,430 | 37,961 | ||||||||||
Lease liabilities |
155 | 272 | ||||||||||
|
|
|
|
|||||||||
Total non-current liabilities |
30,839 | 38,511 | ||||||||||
Current liabilities |
||||||||||||
Trade and other payables |
8,434 | 10,674 | ||||||||||
Provisions |
9 | 497 | 517 | |||||||||
Borrowings |
10 | 1,401 | 2,105 | |||||||||
Lease liabilities |
522 | 532 | ||||||||||
Contract liabilities |
24,137 | 21,353 | ||||||||||
|
|
|
|
|||||||||
Total current liabilities |
34,991 | 35,181 | ||||||||||
TOTAL EQUITY AND LIABILITIES |
97,016 | 112,359 |
The notes are an integral part of these consolidated financial statements.
Affimed N.V.
Unaudited consolidated statements of cash flows (in thousand)
For the three months ended March 31 |
||||||||||||
Note | 2020 | 2019 | ||||||||||
Cash flow from operating activities |
||||||||||||
Income / (loss) for the period |
(8,289 | ) | 1,852 | |||||||||
Adjustments for the period: |
||||||||||||
- Depreciation and amortization |
280 | 210 | ||||||||||
- Net gain from disposal of leasehold improvements and equipment |
0 | (9 | ) | |||||||||
- Share based payments |
8 | 727 | 601 | |||||||||
- Finance income / costs net |
4 | (1,607 | ) | (834 | ) | |||||||
|
|
|
|
|||||||||
(8,889 | ) | 1,820 | ||||||||||
Change in trade and other receivables |
(750 | ) | (6,688 | ) | ||||||||
Change in inventories |
(41 | ) | (65 | ) | ||||||||
Change in other assets |
0 | (183 | ) | |||||||||
Change in trade, other payables, provisions and contract liabilities |
(6,999 | ) | (8,252 | ) | ||||||||
|
|
|
|
|||||||||
Cash used in operating activities |
(16,679 | ) | (13,368 | ) | ||||||||
Interest received |
160 | 62 | ||||||||||
Paid interest |
(28 | ) | (77 | ) | ||||||||
|
|
|
|
|||||||||
Net cash used in operating activities |
(16,547 | ) | (13,383 | ) | ||||||||
Cash flow from investing activities |
||||||||||||
Purchase of intangible assets |
(2 | ) | (64 | ) | ||||||||
Purchase of leasehold improvements and equipment |
(20 | ) | (66 | ) | ||||||||
Cash paid for investments in financial assets |
0 | (21,061 | ) | |||||||||
Cash received from maturity of financial assets |
3,736 | 3,513 | ||||||||||
|
|
|
|
|||||||||
Net cash used for investing activities |
3,714 | (17,678 | ) | |||||||||
Cash flow from financing activities |
||||||||||||
Repayment of lease liabilities |
(128 | ) | (82 | ) | ||||||||
Repayment of borrowings |
10 | (773 | ) | (833 | ) | |||||||
|
|
|
|
|||||||||
Cash flow from financing activities |
(901 | ) | (915 | ) | ||||||||
|
|
|
|
|||||||||
Exchange-rate related changes of cash and cash equivalents |
1,265 | 236 | ||||||||||
Net changes to cash and cash equivalents |
(13,734 | ) | (31,976 | ) | ||||||||
Cash and cash equivalents at the beginning of the period |
95,234 | 94,829 | ||||||||||
|
|
|
|
|||||||||
Cash and cash equivalents at the end of the period |
82,765 | 63,089 | ||||||||||
|
|
|
|
The notes are an integral part of these consolidated 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, 2019 |
624 | 239,055 | 2,594 | (202.144 | ) | 40,129 | ||||||||||||||||
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|
|
|
|
|
|
|
|
|
|||||||||||||
Equity-settled share based payment awards |
8 | 601 | 601 | |||||||||||||||||||
Income for the period |
1,852 | 1,852 | ||||||||||||||||||||
Other comprehensive income |
73 | 73 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance as of March 31, 2019 |
624 | 239,656 | 2,667 | (200,292 | ) | 42,655 | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance as of January 1, 2020 |
762 | 270,451 | 1,962 | (234,508 | ) | 38,667 | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Equity-settled share based payment awards |
8 | 727 | 727 | |||||||||||||||||||
Loss for the period |
(8,289 | ) | (8,289 | ) | ||||||||||||||||||
Other comprehensive income |
81 | 81 | ||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||||
Balance as of March 31, 2020 |
762 | 271,178 | 2,043 | (242,797 | ) | 31,186 | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
The notes are an integral part of these consolidated financial statements.
1. | Reporting entity |
Affimed N.V. is a Dutch company with limited liability (naamloze vennootschap) and has its corporate seat in Amsterdam, the Netherlands. The consolidated financial statements are comprised of Affimed N.V., and its controlled (and wholly owned) subsidiaries Affimed GmbH, Heidelberg, Germany, AbCheck s.r.o., Plzen, Czech Republic, Affimed Inc., Delaware, USA and AbCheck Inc., Delaware, USA (together Affimed, the Company or the Group).
Affimed is a clinical-stage immuno-oncology company focused on discovering and developing highly targeted cancer immunotherapies. The Groups product candidates represent 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, pursuant to which Affimed is performing research services for third parties.
2. | Basis of preparation and changes to Groups accounting policies |
Statement of compliance
The interim financial statements for the three months ended March 31, 2020 and 2019 have been prepared in accordance with IAS 34 Interim Financial Reporting. The interim financial statements do not include all the information and disclosures required in the annual financial statements, and should be read in conjunction with Affimed N.V.s annual consolidated financial statements as of December 31, 2019.
The interim financial statements were authorized for issuance by the management board on June 23, 2020.
Critical judgments and accounting estimates
The preparation of the interim financial statements in conformity with IFRS requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimates are revised and in any future periods affected.
In preparing these interim financial statements, the critical judgments made by management in applying the Companys accounting policies were the same as those that applied to the consolidated financial statements as of and for the year ended December 31, 2019.
Functional and presentation currency
These interim financial statements are presented in Euro, which is the functional currency of all consolidated entities. All financial information presented in Euro has been rounded to the nearest thousand (abbreviated ) or million (abbreviated million).
Significant accounting policies
The accounting policies applied by the Company in these interim financial statements are the same as those applied by the Company in its consolidated financial statements as of and for the year ended December 31, 2019 with the exception of new amendments to standards and new or amended interpretations applied for the first time as described below.
New standards and interpretations applied for the first time
The following amendments to standards and new or amended interpretations are effective for annual periods beginning on or after January 1, 2020, and have been applied in preparing these financial statements:
Standard/interpretation | Effective Date | |
Amendments to References to the Conceptional Framework |
January 1, 2020 | |
Amendments to IAS 1 and IAS 8: Definition of Material |
January 1, 2020 | |
Amendments to IFRS 9, IAS 39 and IFRS 7: |
||
Interest Rate Benchmark Reform |
January 1, 2020 | |
Amendments to IFRS 3 Business Combination |
January 1, 2020 |
None of the amendments to standards and new or amended interpretations had a material effect on the interim financial statements.
Fair Value Measurement
All assets and liabilities for which fair value is recognized in the interim financial statements are classified in accordance with the following fair value hierarchy, based on the lowest level input parameter that is significant on the whole for fair value measurement:
| Level 1 Prices for identical assets or liabilities quoted in active markets (non-adjusted) |
| Level 2 Measurement procedures, in which the lowest level input parameter significant on the whole for fair value measurement is directly or indirectly observable for on the market |
| Level 3 Measurement procedures, in which the lowest level input parameter significant on the whole for fair value measurement is not directly or indirectly observable for on the market |
The carrying amount of all trade and other receivables, certificates of deposit, cash and cash equivalents and trade and other payables is a reasonable approximation of the fair value and, therefore, information about the fair values of those financial instruments has not been disclosed. The measurement of the fair value of the shares held by the group and note disclosure for the fair value of a loan (financial liability) is based on level 2 measurement procedures (see notes 5 and 10).
3. | Revenue |
Collaboration agreement The Leukemia & Lymphoma Society (LLS)
Affimed is party to a collaboration with LLS to fund the development of specific product candidates (immune cell engagers). Under the terms of the agreement, LLS has agreed to contribute up to $4.4 million contingent upon the achievement of certain milestones.
In the event that the research and development is successful, Affimed must proceed with commercialization of the licensed product. If Affimed decides for business reasons not to continue the commercialization, Affimed must at its option either repay the amount funded or grant a license to LLS to enable LLS to continue with the development program. In addition, LLS is entitled to receive royalties from Affimed based on the Groups future revenue from any licensed product, with the amount of royalties not to exceed three times the amount funded.
In June 2016, the research funding agreement with LLS was amended to reflect a shift to the development of combination therapeutic approaches so that the milestones now relate primarily to the development of a combination therapy.
During the three months ended March 31, 2020, the Company recognized revenue totalling 0.1 million (2019: 0 million).
Collaboration with Genentech Inc.
In August 2018, Affimed entered into a strategic collaboration agreement with Genentech Inc., headquartered in South San Francisco, USA. Under the terms of the agreement Affimed will develop novel NK cell engager-based immunotherapeutics to treat multiple cancers. The Genentech agreement became effective at the beginning of October 2018. Affimed received $96.0 million (83.2 million) in initial upfront and committed funding on October 31, 2018.
The Group recognized 4.8 million and 10.6 million as revenue during the three months ended March 31, 2020 and 2019, respectively. As of March 31, 2020, contract liabilities of 54.5 million (December 31, 2019: 59.3 million) will be recognized as revenue in subsequent periods.
Under the terms of the agreement, Affimed is eligible to receive up to an additional $5.0 billion over time, including payments upon achievement of specified development, regulatory and commercial milestones. Affimed is also eligible to receive royalties on any potential sales.
Research service agreements
The Group, through its subsidiary AbCheck s.r.o. has entered into certain research service agreements. These research service agreements provide for non-refundable upfront technology access research funding or capacity reservation fees and milestone payments. The Company recognized 0.2 million as revenue in the three months ended March 31, 2020 (2019: 0.7 million).
Contract balances
The following table provides information about receivables and contract liabilities from contracts with customers.
March 31, 2020 | December 31, 2019 | |||||||
Receivables |
146 | 204 | ||||||
Contract liabilities |
54,567 | 59,314 |
An amount of 4,952 recognized in contract liabilities at the beginning of the period has been recognized as revenue during the three months ended March 31, 2020.
The remaining performance obligations as of March 31, 2020 are approximately 54.6 million and are expected to be recognized as revenue to a large extent over the next two years.
Disaggregation of revenue
Geographic information
Three months ended March 31, 2020 |
Three months ended March 31, 2019 |
|||||||
Revenue: |
||||||||
Germany |
75 | 0 | ||||||
Europe |
2 | 752 | ||||||
USA |
5,058 | 10,601 | ||||||
|
|
|
|
|||||
5,135 | 11,353 | |||||||
|
|
|
|
Major service lines
Three months ended March 31, 2020 |
Three months ended March 31, 2019 |
|||||||
Collaboration revenue |
4,923 | 10,601 | ||||||
Service revenue |
212 | 752 | ||||||
|
|
|
|
|||||
5,135 | 11,353 | |||||||
|
|
|
|
Timing on revenue recognition
Three months ended March 31, 2020 |
Three months ended March 31, 2019 |
|||||||
Point in time |
177 | 5,633 | ||||||
Over time |
4,958 | 5,720 | ||||||
|
|
|
|
|||||
5,135 | 11,353 | |||||||
|
|
|
|
4. | Finance income and finance costs |
Three months ended March 31, 2020 |
Three months ended March 31, 2019 |
|||||||
Interest SVB Loan Agreement |
(57) | (155) | ||||||
Foreign exchange differences |
1,576 | 756 | ||||||
Finance cost lease liability |
(7) | (6) | ||||||
Other finance income/finance costs |
95 | 239 | ||||||
|
|
|
|
|||||
Finance income/costs - net |
1,607 | 834 |
5. | Long term financial assets |
The Company holds preferred shares in Amphivena recognized at their fair value of 3.3 million. As of March 31, 2020 the fair value increased by 0.1 million due to exchange rate differences recognized in other comprehensive income (2019: 0.1 million).
6. | Financial assets |
As of March 31, 2020 and December 31, 2019, financial assets consisted of U.S. Dollar denominated certificates of deposit with original maturities of more than three months.
7. | Equity |
As of March 31, 2020 the share capital of 762 (December 31, 2019: 762) is divided into 76,249,901 (December 31, 2019: 76,249,901) common shares with a par value of 0.01 per share.
8. | Share-based payments |
In 2014, an equity-settled share-based payment program was established by Affimed N.V. (ESOP 2014). Under this program, the Company granted awards to certain members of the Management Board, the Supervisory Board, non-employee consultants and employees.
Share based payments with service condition
The majority of the awards vest in instalments over three years and can be exercised up to 10 years after the grant date. The Group granted 909,809 awards in the three months ended March 31, 2020 to employees. 124,412 ESOP 2014 awards were cancelled or forfeited and no options were exercised. As of March 31, 2020, 8,092,964 (December 31, 2019: 7,307,567) ESOP 2014 options were outstanding, and 5,366,419 awards (December 31, 2019: 4,773,840) had vested. The options outstanding as of March 31, 2020 had an exercise price in the range of $1.30 to $13.47.
Share based payments with market condition
On April 20, 2018, Affimed issued 240,000 options, of which each grant consists of three tranches that vest when the volume-weighted average share price (measured based on Affimed closing share prices over the preceding fifteen trading days) reaches a certain hurdle ($6.15, $8.20 and $10.25). Fair value of the awards at grant date amounts to 133 ($164 thousand) and the contractual life time of the options is two years. As of March 31, 2020 no options were exercisable.
Share based payment expense
In the three months ended March 31, 2020, compensation expense of 727 was recognized affecting research and development expenses (317) and general and administrative expenses (410). In the three months ended March 31, 2019, compensation expense of 601 was recognized affecting research and development expenses (269) and general and administrative expenses (332).
Fair value measurement
The fair value of options was determined using the Black-Scholes valuation model. The significant inputs into the valuation model of share based payment grants with service conditions are as follows (weighted average):
March 31, 2020 | March 31, 2019 | |||||||
Fair value at grant date |
$ | 1.69 | $ | 2.18 | ||||
Share price at grant date |
$ | 2.66 | $ | 3.17 | ||||
Exercise price |
$ | 2.66 | $ | 3.15 | ||||
Expected volatility |
90 | % | 80 | % | ||||
Expected life |
5.90 | 5.90 | ||||||
Expected dividends |
0.00 | 0.00 | ||||||
Risk-free interest rate |
1.70 | % | 2.60 | % |
Expected volatility is estimated based on the observed daily share price returns of a peer group measured over a historic period equal to the expected life of the awards.
The risk-free interest rates are based on the yield to maturity of U.S. Treasury strips and German sovereign strips respectively (as best available indication for risk-free rates), for a term equal to the expected life, as measured as of the Grant Date.
9. | Provisions |
In 2019, the group recognized costs related to the termination of the AFM 11 program totalling to 1.4 million, whereof 0.9 million were already incurred in 2019. Estimated costs expected to incur in 2020 were recognized in provisions (0.5 million, December 31, 2019: 0.5 million).
10. | Borrowings |
Silicon Valley Bank
On November 30, 2016, the Company entered into a loan agreement with Silicon Valley Bank (the SVB loan) which provides the Company with a senior secured term loan facility for up to 10.0 million, which agreement was amended in May 2017 to provide that such amount would be available in three tranches. In December 2016, the Company drew an initial tranche of 5.0 million and in May 2017, a second tranche of 2.5 million; the availability of a third tranche of 2.5 million expired in September 2017 with such amount remaining undrawn.
Finance costs comprise the interest rate of one-month EURIBOR plus an applicable margin of 5.5%, with a floor of 5.5%, related one-time legal and arrangement fees of 236 and a final payment fee equal to 10% of the total principal amount to be paid with the last instalment. Pursuant to the loan agreement, the Company also granted the lender 166,297 and 53,395 warrants with an exercise price of $2.00 and $2.30 per share, respectively. Each warrant can be used to purchase common shares of Affimed at the respective exercise price for a period of ten years from the date of grant. The fair value of the warrants of 192 less deferred taxes and transaction costs of 81 and 8, respectively, was recorded as an addition to capital reserves in the equity of Affimed. The fair value of the warrants was determined using the Black-Scholes-Merton valuation model, with an expected volatility of 75 to 80% and an expected exercise period of five years to exercise of the warrant. The contractual maturity of the warrants is ten years.
The loan is secured by a pledge of 100% of Companys ownership interest in Affimed GmbH, all intercompany claims owed to Affimed N.V. by its subsidiaries, and collateral agreements for all bank accounts, inventory, trade receivables and other receivables of Affimed N.V. and Affimed GmbH recognized in the consolidated financial statements.
As of March 31, 2020 and December 31, 2019, the fair value of the liability did not differ significantly from its carrying amount (1,310 and 2,013). Repayment started in December 2017 with amortized payments of principal and interest in equal monthly instalments. In April 2020 the Company agreed with Silicon Valley Bank to extend the original maturity date of May 31, 2020 by six months to November 30, 2020. As of March 31, 2020, 1,310 (December 31, 2019: 2,013) was classified as current liabilities.
UniCredit Leasing CZ
In April 2019, the Group entered into a loan agreement with UniCredit Leasing CZ for 562. After an initial instalment of 127 in the second quarter of 2019, repayment is effected in monthly instalments of 8 until November 2023. As of March 31, 2020, an amount of 346 (December 31, 2019: 368) was outstanding, of which 91 was classified as current liabilities (December 31, 2019: 93). As of March 31, 2020, the fair value of the liability did not differ significantly from its carrying amount.
11. | Related parties |
The supervisory directors of Affimed N.V. received compensation for their services on the supervisory board of 85 (95) in the three months ended March 31, 2020 (2019), remuneration of managing directors and other key management personnel amounted to 605 (724). The payments in the three months ended March 31, 2020 include payments following the death of our former Chief Financial Officer (CFO), Florian Fischer, amounting to 120.
The Company recognized share-based payment expenses of 36 (20) for supervisory directors and 360 (403) for managing directors and other key management personnel in the three months ended March 31, 2020 (2019).
The following table provides the outstanding balances for management and supervisory board remuneration.
Outstanding balances | ||||||||
March 31, 2020 |
December 31, 2019 |
|||||||
Adi Hoess |
0 | 5 | ||||||
Wolfgang Fischer |
0 | 1 | ||||||
Dr. Thomas Hecht |
19 | 26 | ||||||
Berndt Modig |
7 | 9 | ||||||
Ferdinand Verdonck |
9 | 11 | ||||||
Dr. Ulrich Grau |
17 | 21 | ||||||
Dr. Bernhard Ehmer |
12 | 20 | ||||||
Mathieu Simon |
6 | 9 |
12. | Subsequent events |
The Company announced in early February 2020 that Dr. Florian Fischer, CFO of Affimed, passed away. During Affimeds search for a new CFO, Harry Welten assumed the operating responsibilities as CFO advisor to Affimed. In June 2020, the Company announced the appointment of Angus Smith as Affimeds new permanent CFO, completing Affimeds leadership team. Mr. Smith will begin his employment on July 13, 2020 and will be based in Affimeds New York office.
The Company also announced the appointment of Dr. Arndt Schottelius as Chief Scientific Officer, effective April 2020.
In May 2020, the Company implemented an at-the-market (ATM) program providing for the sales over time of up to $50,000,000 of its common shares. The offering has been conducted under the Companys effective shelf registration statement on Form F-3 pursuant to a prospectus supplement and the entry into a sales agreement with Jefferies LLC. As of June 23, 2020, the Company has issued approximately 7.6 million common shares under the ATM program, generating net proceeds of approximately $21.0 million.
As circumstances around the COVID-19 pandemic continue to rapidly evolve, Affimed is continuously assessing possible effects on its clinical trials and adapting the risk mitigation measures it has implemented. Affimed is closely monitoring and adhering to relevant federal and local guidelines on COVID-19 to ensure the safety and health of its global workforce and help limit the spread of COVID-19, while maintaining business continuity. The Company has taken mitigation steps to ensure that drug supply and other trial-related materials are ready and available for the patients enrolled in its clinical trials. Due to the ongoing assessment of the potential impact of the COVID-19 pandemic on patient enrollment and site activation in its clinical studies, Affimed plans to update trial timelines after it has more visibility on the length and extent of the COVID-19 crisis.
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 interim condensed consolidated financial statements for the three month periods ended March 31, 2020 and 2019 included as Exhibit 99.1 to the Report on Form 6-K in which this discussion is included. We also recommend that you read Item 4. Information on the Company and our audited consolidated financial statements for fiscal year 2019, and the notes thereto, which appear in our Annual Report on Form 20-F for the year ended December 31, 2019 (the Annual Report) filed with the U.S. Securities and Exchange Commission (the SEC).
Unless otherwise indicated or the context otherwise requires, all references to Affimed or the company, we, our, ours, us or similar terms refer to Affimed N.V. and its subsidiaries.
We prepare and report our consolidated financial statements and financial information in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (the IASB). None of our financial statements were prepared in accordance with generally accepted accounting principles in the United States. 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, 2020, we have raised an aggregate of approximately 258.4 million (gross proceeds) through the issuance of equity and incurrence of loans. To date, we have not generated any revenues from product sales or royalties. Based on our current plans, we do not expect to generate product or royalty revenues unless and until we or any collaboration partner obtain marketing approval for, and commercialize, any of our product candidates.
We have generated losses since we began our drug development operations in 2000. As of March 31, 2020, we had an accumulated deficit of 242.8 million.
Notwithstanding our collaboration with Genentech and the income earned for the three month periods ended March 31, 2020 and anticipated in the remainder of 2020 upon the achievement of specified milestones, 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 cash. We intend to fund future operations through additional equity and debt financings, and we may seek additional capital through arrangements with strategic partners or from other sources.
In 2009, we formed AbCheck, our 100% owned, independently run antibody screening platform company, located in the Czech Republic. AbCheck is devoted to the generation and optimization of fully human antibodies. Its technologies include a naïve human antibody library combined with a phage and yeast display antibody library, a proprietary algorithm to optimize affinity, stability and manufacturing efficiency and a mass humanization technology to discover and optimize high-quality human antibodies. In addition to providing candidates for Affimed projects, AbCheck is recognized for its expertise in antibody discovery throughout the United States and Europe and has been working with globally active pharmaceutical and biotechnology companies such as Tusk Therapeutics, bluebird bio, Eli Lilly, Daiichi Sankyo, Pierre Fabre and others.
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We have one U.S. subsidiary, Affimed Inc., with senior employees in finance, investor relations, business development, corporate strategy and clinical operations.
Recent Developments
The Company announced early February 2020 that Dr. Florian Fischer, Chief Financial Officer (CFO) of Affimed, passed away. During Affimeds search for a new CFO, Harry Welten assumed the operating responsibilities as CFO advisor to Affimed. In June 2020, the Company announced the appointment of Angus Smith as Affimeds new permanent CFO, completing Affimeds leadership team. Mr. Smith will begin his employment on July 13, 2020 and will be based out of Affimeds New York office. In addition, the Company announced the appointment of Dr. Andreas Harstrick as Chief Medical Officer, starting in March 2020 and the appointment of Dr. Arndt Schottelius as Chief Scientific Officer, effective April 2020.
In May 2020, the Company implemented an at-the-market (ATM) program providing for the sales over time of up to $50,000,000 of its common shares. The offering was conducted under the Companys effective shelf registration statement on Form F-3 pursuant to a prospectus supplement and the entry into a sales agreement with Jefferies LLC. As of June 23, 2020, the Company has issued approximately 7.6 million common shares under the ATM program, generating net proceeds of approximately $21.0 million.
As circumstances around the COVID-19 pandemic continue to rapidly evolve, Affimed is continuously assessing possible effects on its clinical trials and adapting the risk mitigation measures it has implemented. Affimed is closely monitoring and adhering to relevant federal and local guidelines on COVID-19 to ensure the safety and health of its global workforce and help limit the spread of COVID-19, while maintaining business continuity. The Company has taken mitigation steps to ensure that drug supply and other trial-related materials are ready and available for the patients enrolled in its clinical trials. Due to the ongoing assessment of the potential impact of the COVID-19 pandemic on patient enrollment and site activation in its clinical studies, Affimed plans to update trial timelines after it has more visibility on the length and extent of the COVID-19 crisis.
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. In November 2019, we initiated a registration directed phase 2 study of AFM13 as monotherapy in relapsed or refractory patients suffering from peripheral T cell lymphoma (pTCL). The study protocol has been agreed upon with the U.S. Food and Drug Administration (FDA). In addition, this study will, as a separate cohort, investigate the initial efficacy of AFM13 as monotherapy in patients suffering from transformed mycosis fungoides (T-MF). In September 2019, the FDA cleared an investigational new drug application (IND) for an investigator-sponsored Phase 1 study, in which the University of Texas MD Anderson Cancer Center (MDACC) plans to investigate the combination of AFM13 with allogeneic NK cells. MDACC intends to administer a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells in different doses (numbers of pre-loaded NK cells) into patients with relapsed/refractory CD30-positive lymphoid malignancies. In 2017, an investigator-sponsored Phase 1b/2a study was initiated by Columbia University to investigate AFM13 as monotherapy in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation. In 2016, we initiated a phase 1b study investigating the combination of AFM13 with Mercks anti-PD1 antibody Keytruda® (pembrolizumab) in patients with relapsed/refractory HL. In this study, enrollment is complete and final data were recently presented. Different dosing protocols are being explored in the investigator-initiated monotherapeutic phase 2a clinical trial of AFM13 in relapsed/refractory Hodgkin Lymphoma, or relapsed/refractory HL, to allow for improved exposure in more heavily pretreated patient populations. The study has now completed recruitment under the new study design. We anticipate that our research and development expenses in 2020 for AFM13 will increase compared to those for 2019 due to the initiation of new clinical studies, pre-clinical studies with collaboration partners and the preparation of the production of AFM13 for commercial purposes. |
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| AFM11. In line with the strategic focus on our innate cell engager portfolio, we have made the decision to terminate the Phase 1 clinical program of AFM11. This decision took into consideration the competitive landscape of B-cell directed therapies currently in development and associated resources needed for further development of AFM11. We subsequently informed the FDA of our intention to terminate the clinical program. |
| AFM24. AFM24, a tetravalent, bispecific epidermal growth factor receptor, and CD16A-binding innate cell engager, is in effect for a phase 1/2a clinical trial in patients with advanced cancers known to express EGFR. We anticipate that our research and development expenses in the remainder of 2020 for AFM24 will increase compared to those for 2019 due to the beginning of the clinical trial of AFM24 in patients. |
| Other projects and infrastructure costs. Our other research and development expenses relate to our Genentech collaboration, Affimed owned preclinical programs (AFM28 and AFM32) and early stage development/discovery activities. We have allocated a material amount of our resources to such discovery activities. The expenses mainly consist of salaries, manufacturing costs for pre-clinical study material and pre-clinical studies. In addition, we incur a significant amount of costs associated with our research and development that are non-project specific, including intellectual property-related expenses, depreciation expenses and facility costs. Because these are less dependent on individual ongoing programs, they are not allocated to specific projects. We assume that other projects and infrastructure costs will increase in the remainder of 2020 due to increased early stage development/discovery activities. |
Results of Operations
The financial information shown below was derived from our unaudited interim condensed consolidated financial statements for the three month periods ended March 31, 2020 and 2019. The discussion below should be read along with these financial statements, and it is qualified in its entirety by reference to them.
Comparison of the three months ended March 31, 2020 and 2019
Three months ended March 31, |
||||||||
2020 | 2019 | |||||||
(unaudited) | ||||||||
(in thousand) | ||||||||
Total Revenue: |
5,135 | 11,353 | ||||||
Other income (expenses)net |
(57 | ) | 86 | |||||
Research and development expenses |
(11,449 | ) | (7,987 | ) | ||||
General and administrative expenses |
(3,525 | ) | (2,434 | ) | ||||
Operating income/(loss) |
(9,896 | ) | 1,018 | |||||
Finance income/(costs)net |
1,607 | 834 | ||||||
Income/(loss) before tax |
(8,289 | ) | 1,852 | |||||
Income taxes |
0 | 0 | ||||||
Income/(loss) for the period |
(8,289 | ) | 1,852 | |||||
Other comprehensive income/(loss) |
81 | 73 | ||||||
Total comprehensive income/(loss) |
(8,208 | ) | 1,925 | |||||
Earnings/(loss) per common share in per share (undiluted) |
(0.11 | ) | 0.03 | |||||
Earnings/(loss) per common share in per share (diluted) |
(0.11 | ) | 0.03 |
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Revenue
Revenue decreased to 5.1 million in the three months ended March 31, 2020 from 11.4 million for the three months ended March 31, 2019. Revenue in the three months ended March 31, 2020 and 2019 predominantly relate to the Genentech collaboration (4.8 million, 2019: 10.6 million). Revenue from the Genentech collaboration in the three months ended March 31, 2020 was comprised of revenue recognized for collaborative research services performed during the quarter.
Research and development expenses
Three months ended March 31, |
||||||||||||
R&D Expenses by Project | 2020 | 2019 | Change% | |||||||||
(unaudited) | ||||||||||||
(in thousand) | ||||||||||||
Project |
||||||||||||
AFM13 |
5,283 | 2,643 | 100 | % | ||||||||
AFM11 |
22 | 358 | (94 | %) | ||||||||
AFM24 |
1,509 | 1,052 | 43 | % | ||||||||
Other projects and infrastructure costs |
4,318 | 3,665 | 18 | % | ||||||||
Share-based payment expense |
317 | 269 | 18 | % | ||||||||
Total |
11,449 | 7,987 | 43 | % |
Research and development expenses amounted to 11.4 million in the three months ended March 31, 2020 compared to research and development expenses of 8.0 million in the three months ended March 31, 2019. The variances in project-related expenses between the three months ended March 31, 2020 and the corresponding period in 2019 are mainly due to the following projects:
| AFM13. In the three months ended March 31, 2020 we incurred significantly higher expenses (100%) than in the three months ended March 31, 2019 primarily due to higher expenses for the preparation of new clinical trials and manufacturing activities for clinical trial material. |
| AFM11. In the three months ended March 31, 2020, research and development expenses were significantly lower (94%) compared to the three months ended March 31, 2019. The expenses in the three months ended March 31, 2020 are related to costs for the termination of the phase 1 dose-finding study in NHL and the phase 1 dose-finding study in ALL. |
| AFM24. In the three months ended March 31, 2020, we incurred higher expenses due to the initiation of the phase 1/2a clinical trial and manufacturing activities for the clinical trial material. |
| Other projects and infrastructure costs. In the three months ended March 31, 2020, expenses were higher (18%) than in the three months ended March 31, 2019 primarily due to higher expenses incurred in relation to our earlier stage programs and discovery/early stage development activities and infrastructure costs. |
General and administrative expenses
General and administrative expenses were higher and amounted to 3.5 million in the three months ended March 31, 2020 compared to 2.4 million in the three months ended March 31, 2019 mainly due to higher personnel expenses, higher compliance costs with the SarbanesOxley Act of 2002, legal, consulting and audit costs.
Finance income / (costs)-net
Finance income for the three months ended March 31, 2020 totaled 1.6 million, compared to 0.8 million for the three months ended March 31, 2019. Finance income in the three months ended March 31, 2020 and 2019 primarily include foreign exchange gains.
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Liquidity and Capital Resources
Since inception, we have incurred significant operating losses. To date, we have not generated any product sale revenue. We have financed our operations primarily through our public offerings of our common shares, private placements of equity securities and loans, grants and payments from collaboration partners.
Cash flows
The table below summarizes our consolidated statement of cash flows for the three months ended March 31, 2020 and 2019:
Three months ended March 31, |
||||||||
2020 | 2019 | |||||||
(unaudited) | ||||||||
(in thousand) | ||||||||
Net cash used in operating activities |
(16,547 | ) | (13,383 | ) | ||||
Net cash used for/generated from investing activities |
3,714 | (17,678 | ) | |||||
Net cash generated from/used in financing activities |
(901 | ) | (915 | ) | ||||
Exchange rate related changes of cash and cash equivalents |
1,265 | 236 | ||||||
Net changes to cash and cash equivalents |
(13,734 | ) | (31,976 | ) | ||||
Cash and cash equivalents at the beginning of the period |
95,234 | 94,829 | ||||||
Cash and cash equivalents at the end of the period |
82,765 | 63,089 |
Net cash used in operating activities of 16.5 million in the three months ended March 31, 2020 is higher than net cash used in operating activities in the three months ended March 31, 2019 (13.4 million) primarily due to higher cash expenditure for research and development efforts. The investing activities in the three months ended March 31, 2020 primarily relate to proceeds from the sale or maturity of financial assets, while in the three months ended March 31, 2019 investing activities mainly relate to the investment in and proceeds from the sale or maturity of financial assets. Net cash used in financing activities in the three months ended March 31, 2020 and 2019 relate primarily to the repayment of borrowings.
Cash and Funding Sources
Our cash and cash equivalents and financial assets as of March 31, 2020 were 88.2 million, compared with 104.1 million as of December 31, 2019. Funding sources generally comprise proceeds from the issuance of equity instruments, payments from collaboration agreements, loans and government grants.
Funding Requirements
We expect that we will require additional funding to complete the development of our product candidates and to continue to advance the development of our other product candidates. If we receive regulatory approval for AFM13, AFM24 or other earlier programs, and if we choose not to grant any licenses to partners, we expect to incur significant commercialization expenses related to product manufacturing, sales, marketing and distribution, depending on where we choose to commercialize. We also continue to incur substantial costs associated with operating as a public company. Additional funds may not be available on a timely basis, on favorable terms, or at all, and such funds, if raised, may not be sufficient to enable us to continue to implement our long-term business strategy. If we are not able to raise capital when needed, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
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Based on our current operating and budget assumptions, we believe that our existing liquidity together with the proceeds generated in the second quarter of 2020 from our ATM program, will enable us to fund our operating expenses and capital expenditure requirements well into the first half of 2022. 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.
Contractual Obligations and Commitments
As of the date of this discussion and analysis there are no material changes to our contractual obligations from those reported in Item 5. Operating and Financial Review and ProspectsF. Tabular disclosure of contractual obligations in the Annual Report.
Off-balance Sheet Arrangements
As of the date of this discussion and analysis, we do not have any, and during the periods presented we did not have any, off-balance sheet arrangements other than operating leases as described under Item 5. Operating and Financial Review and ProspectsF. Tabular disclosure of contractual obligations in the Annual Report.
Quantitative and Qualitative Disclosures About Market Risk
During the three months ended March 31, 2020, there were no significant changes to our quantitative and qualitative disclosures about market risk from those reported in Item 11. Quantitative and Qualitative Disclosures About Risk in the Annual Report.
Critical Judgments and Accounting Estimates
There have been no material changes to the significant accounting policies and estimates described in Item 5. Operating and Financial Review and 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 condensed consolidated financial statements for the three month periods ended March 31, 2020 and 2019 with regard to the impact of recent accounting pronouncements.
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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, 2020, our accumulated deficit was 242.8 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 AFM24 and AFM13 (which are still in clinical development) and certain of our other product candidates, each of which may eventually prove to be unsuccessful or commercially not exploitable; |
| uncertainty surrounding whether any of our product candidates will gain regulatory approval, which is necessary before they can be commercialized; |
| the outcome of any, or any discussions we may enter regarding, acquisitions, dispositions, partnerships, license transactions or changes to our capital structure, including our receipt of any milestone payments or royalties or any future securities offerings; |
| the chance that we may become exposed to costly and damaging liability claims resulting from the testing of our product candidates in the clinic or in the commercial stage; |
| if our product candidates obtain regulatory approval, our being subject to expensive ongoing obligations and continued regulatory overview; |
| enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval and commercialization; |
| future legislation may materially impact our ability to realize revenue from any approved and commercialized products; |
| the chance that our products may not gain market acceptance, in which case we may not be able to generate product revenues; |
| our reliance on our current strategic relationships with LLS, Merck, The MD Anderson Cancer Center, Genentech, Amphivena and the potential failure to enter into new strategic relationships; |
| our reliance on third parties to conduct our nonclinical and clinical trials and on third-party single-source suppliers to supply or produce our product candidates; |
| our ability to scale-up manufacturing processes of our product candidates and reduce the cost of manufacturing our product candidates in advance of any commercialization; |
| our future growth and ability to compete, which depends on retaining our key personnel and recruiting additional qualified personnel; |
| the length and severity of the COVID-19 outbreak and its impact on our business, including our supply chain, clinical trials and operations; and |
| other risk factors discussed under Item 3. Key InformationD. Risk Factors in the Annual Report. |
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Our actual results or performance could differ materially from those expressed in, or implied by, any forward-looking statements relating to those matters. Accordingly, no assurances can be given that any of the events anticipated by the forward-looking statements will transpire or occur, or if any of them do so, what impact they will have on our results of operations, cash flows or financial condition. Additionally, some of the risks and uncertainties identified above may be amplified by the recent COVID-19 outbreak. It is not possible to predict or identify all such risks. There may be additional risks that we consider immaterial or which are unknown. Except as required by law, we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.
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Exhibit 99.3
PRESS RELEASE
Affimed Reports First Quarter 2020 Financial Results and Operational Progress
| AFM24: Affimed successfully completed the first dose cohort of its first-in-human phase 1/2A Study; Cohort 2 is open for patient recruitment |
| Data on Affimeds AFM24 (EGFR/CD16A) and Genentechs RO7297089 (BCMA/CD16A) was presented at AACR Virtual Meeting II, showing potent killing of tumor cell lines and a good safety profile in the relevant pre-clinical models |
| AFM13: Continued progress on the REDIRECT monotherapy study in pTCL as well as on the AFM13 combination with cbNk investigator sponsored study at MD Anderson Cancer Center in CD30-positive T cell lymphoma |
| Management: Appointed Angus Smith as Chief Financial Officer, following the appointments of Dr. Andreas Harstrick as Chief Medical Officer and Dr. Arndt Schottelius as Chief Scientific Officer earlier in the year, completing the management team |
| Conference call and webcast scheduled for June 23, 2020 at 8:30 am EDT (2:30 pm CET) |
Heidelberg, Germany, June 23, 2020 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, today reported financial results for the first quarter 2020 and provided an update on clinical and corporate progress.
We continue to move our clinical programs forward in close collaboration with our investigators and partners, said Dr. Adi Hoess, CEO of Affimed. We have strengthened the management team with the recent hiring of Angus Smith as CFO, which nicely complements the additions of Dr. Andreas Harstrick as CMO and Dr. Arndt Schottelius as CSO earlier in the year. With good progress in our clinical programs, the pre-clinical pipeline and the completion of the management team, we are well positioned to increase our leadership position as innovators of innate immune system-based therapeutics.
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Development Program Updates
AFM13 (CD30/CD16A)
| Affimed has successfully activated 46 clinical study sites in nine countries in the on-going Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with CD30-positive peripheral T-cell lymphoma (pTCL). |
| The investigator-sponsored Phase 1 study with the University of Texas, MD Anderson Cancer Center to investigate the combination of AFM13 with allogeneic NK cells in CD30+ Lymphomas has completed the required validation work in order to administer a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells. |
AFM24 (EGFR/CD16A)
| After the successful completion of dose cohort 1, in the first-in-human Phase 1/2a clinical trial of AFM24, the EGFR/CD16A targeted innate cell engager for relapsed/ refractory patients with advanced EGFR-expressing solid tumors, the study was cleared to begin patient recruitment in dose cohort 2. The company reported that no dose limiting toxicity was observed in dose cohort 1. |
| Affimed researchers presented preclinical data on the pharmacology and safety of AFM24 at the AACR Virtual Annual Meeting II. |
Genentech Collaboration Update
| In May 2020, Affimed confirmed that its novel BCMA targeted innate cell engager for the treatment of multiple myeloma has been partnered with Genentech, a member of the Roche Group. |
| Researchers from Genentech and Affimed co-authored a poster on the preclinical pharmacology and safety data of RO7297089 and presented data at the AACR Virtual Annual Meeting II. |
| On clinicaltrials.gov, Genentech has posted a first-in-human Phase I, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of RO7297089. |
Preclinical Pipeline Update
| Affimed continues to progress AFM28 and AFM32 towards late stage preclinical development. |
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Management Appointments
| Angus Smith was appointed to the position of Chief Financial Officer in June and will join the company in mid-July. Mr. Smith brings broad biopharmaceutical experience to the company including financial strategy and planning, capital markets, business development and operations. |
| The company announced the additions of Dr. Andreas Harstrick as Chief Medical Officer and Dr. Arndt Schottelius as Chief Scientific Officer earlier in the year. Dr. Harstrick, brings broad development expertise in solid tumor indications, including EGFR-expressing cancers. Dr. Schottelius brings extensive innate immunity expertise and a successful record of advancing discovery research into preclinical and clinical development. |
First Quarter 2020 Financial Highlights
(Figures for the first quarter ended March 31, 2020 and 2019 are unaudited.)
As of March 31, 2020, cash, cash equivalents and current financial assets totaled 88.2 million compared to 104.1 million on December 31, 2019. In addition, the company raised 18.8 million (based on an exchange rate of $/ of 1.1210 on June 19, 2020) net proceeds under its at-the-market (ATM) program. The pro forma cash position of the company as of March 31, 2020, including the net proceeds from the ATM, would be 107.0 million. Based on its current operating plan and assumptions, Affimed anticipates that its cash, cash equivalents and current financial assets will support operations well into the first half of 2022.
Net cash used in operating activities for the quarter ended March 31, 2020, was 16.5 million, compared to 13.4 million for the quarter ended March 31, 2019. The increase is primarily due to higher expenditure related to research and development efforts.
Total revenue for the quarter ended March 31, 2020, was 5.1 million compared to 11.4 million for the same period of 2019. Revenue in both quarters is primarily attributable to the recognition of revenue from the Genentech collaboration in the respective years.
R&D expenses for the quarter ended March 31, 2020, were 11.4 million compared to research and development expenses of 8.0 million for the same period of 2019. The increase was primarily related to higher expenses for the AFM13 registration-directed study in pTCL, manufacturing activities for AFM13 clinical study material, and early stage development and discovery activities.
General and administrative (G&A) expenses for the quarter ended March 31, 2020, were 3.5 million compared to 2.4 million for the quarter ended March 31, 2019. The increase was primarily related to higher personnel expenses, a result of the strengthening of the talent pool, higher SOX compliance costs, legal, consulting and audit costs.
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Net loss was 8.3 million, or 0.11 per common share, for the quarter ended March 31, 2020, compared to a net income of 1.9 million, or 0.03 per common share, for the quarter ended March 31, 2019.
Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.
Conference Call and Webcast Information
Affimed will host a conference call and webcast today, Tuesday, June 23, 2020 at 8:30 a.m. EDT to discuss first quarter 2020 financial results and recent corporate developments. The conference call will be available via phone and webcast. To access the call, please dial +1 (646) 741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference passcode 8594214 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_cp/. A replay of the webcast will be accessible at the same link for 30 days following the call.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer. Affimeds fit-for-purpose ROCK® platform allows innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and into a Phase 1/2a dose escalation/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. For more information, please visit www.affimed.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as anticipate, believe, could, estimate, expect, goal, intend, look forward to, may, plan, potential, predict, project, should, will, would and similar
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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 AFM24, the value of our ROCK® platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation and the risks, uncertainties and other factors described under the heading Risk Factors in 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 Contact:
Alex Fudukidis
Head of Investor Relations
E-Mail: IR@affimed.com
Tel.: (917) 436-8102
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Affimed N.V.
Unaudited consolidated statements of comprehensive income / (loss) (in thousand)
For the three months ended March 31 | ||||||||
2020 | 2019 | |||||||
Revenue |
5,135 | 11,353 | ||||||
Other income net |
(57 | ) | 86 | |||||
Research and development expenses |
(11,449 | ) | (7,987 | ) | ||||
General and administrative expenses |
(3,525 | ) | (2,434 | ) | ||||
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Operating income / (loss) |
(9,896 | ) | 1,018 | |||||
Finance income / (costs) net |
1,607 | 834 | ||||||
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Income / (loss) before tax |
(8,289 | ) | 1,852 | |||||
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Income / (loss) for the period |
(8,289 | ) | 1,852 | |||||
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Other comprehensive income / (loss) |
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Items that will not be reclassified to profit or loss |
||||||||
Equity investments at fair value OCI - net change in fair value |
81 | 73 | ||||||
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Other comprehensive income / (loss) |
81 | 73 | ||||||
Total comprehensive income / (loss) |
(8,208 | ) | 1,925 | |||||
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Earnings / (loss) per share in per share (undiluted = diluted) |
(0.11 | ) | 0.03 | |||||
Weighted number of common shares outstanding |
76,249,901 | 62,430,106 |
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Affimed N.V.
Consolidated statements of financial position (in thousand)
March 31, 2020 | December 31, 2019 | |||||||
(unaudited) | ||||||||
ASSETS |
||||||||
Non-current assets |
||||||||
Intangible assets |
121 | 137 | ||||||
Leasehold improvements and equipment |
2,193 | 2,291 | ||||||
Long term financial assets |
3,274 | 3,193 | ||||||
Right-of-use assets |
679 | 824 | ||||||
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6,267 | 6,445 | |||||||
Current assets |
||||||||
Cash and cash equivalents |
82,765 | 95,234 | ||||||
Financial assets |
5,476 | 8,902 | ||||||
Trade and other receivables |
2,171 | 1,482 | ||||||
Inventories |
337 | 296 | ||||||
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90,749 | 105,914 | |||||||
TOTAL ASSETS |
97,016 | 112,359 | ||||||
EQUITY AND LIABILITIES |
||||||||
Equity |
||||||||
Issued capital |
762 | 762 | ||||||
Capital reserves |
271,178 | 270,451 | ||||||
Fair value reserves |
2,043 | 1,962 | ||||||
Accumulated deficit |
(242,797 | ) | (234,508 | ) | ||||
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Total equity |
31,186 | 38,667 | ||||||
Non-current liabilities |
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Borrowings |
254 | 278 | ||||||
Contract liabilities |
30,430 | 37,961 | ||||||
Lease liabilities |
155 | 272 | ||||||
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Total non-current liabilities |
30,839 | 38,511 | ||||||
Current liabilities |
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Trade and other payables |
8,434 | 10,674 | ||||||
Provisions |
497 | 517 | ||||||
Borrowings |
1,401 | 2,105 | ||||||
Lease liabilities |
522 | 532 | ||||||
Contract liabilities |
24,137 | 21,353 | ||||||
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Total current liabilities |
34,991 | 35,181 | ||||||
TOTAL EQUITY AND LIABILITIES |
97,016 | 112,359 |
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Affimed N.V.
Unaudited consolidated statements of cash flows (in thousand)
For the three months ended March 31 | ||||||||
2020 | 2019 | |||||||
Cash flow from operating activities |
||||||||
Income / (loss) for the period |
(8,289 | ) | 1,852 | |||||
Adjustments for the period: |
||||||||
- Depreciation and amortization |
280 | 210 | ||||||
- Net gain from disposal of leasehold improvements and equipment |
0 | (9 | ) | |||||
- Share based payments |
727 | 601 | ||||||
- Finance income / costs net |
(1,607 | ) | (834 | ) | ||||
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(8,889 | ) | 1,820 | ||||||
Change in trade and other receivables |
(750 | ) | (6,688 | ) | ||||
Change in inventories |
(41 | ) | (65 | ) | ||||
Change in other assets |
0 | (183 | ) | |||||
Change in trade, other payables, provisions and contract liabilities |
(6,999 | ) | (8,252 | ) | ||||
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Cash used in operating activities |
(16,679 | ) | (13,368 | ) | ||||
Interest received |
160 | 62 | ||||||
Paid interest |
(28 | ) | (77 | ) | ||||
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Net cash used in operating activities |
(16,547 | ) | (13,383 | ) | ||||
Cash flow from investing activities |
||||||||
Purchase of intangible assets |
(2 | ) | (64 | ) | ||||
Purchase of leasehold improvements and equipment |
(20 | ) | (66 | ) | ||||
Cash paid for investments in financial assets |
0 | (21,061 | ) | |||||
Cash received from maturity of financial assets |
3,736 | 3,513 | ||||||
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Net cash used for investing activities |
3,714 | (17,678 | ) | |||||
Cash flow from financing activities |
||||||||
Repayment of lease liabilities |
(128 | ) | (82 | ) | ||||
Repayment of borrowings |
(773 | ) | (833 | ) | ||||
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Cash flow from financing activities |
(901 | ) | (915 | ) | ||||
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Exchange-rate related changes of cash and cash equivalents |
1,265 | 236 | ||||||
Net changes to cash and cash equivalents |
(13,734 | ) | (31,976 | ) | ||||
Cash and cash equivalents at the beginning of the period |
95,234 | 94,829 | ||||||
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Cash and cash equivalents at the end of the period |
82,765 | 63,089 | ||||||
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Affimed N.V.
Unaudited consolidated statements of changes in equity (in thousand)
Issued capital | Capital reserves | Fair value reserves |
Accumulated deficit |
Total equity |
||||||||||||||||
Balance as of January 1, 2019 |
624 | 239,055 | 2,594 | (202.144 | ) | 40,129 | ||||||||||||||
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Equity-settled share based payment awards |
601 | 601 | ||||||||||||||||||
Income for the period |
1,852 | 1,852 | ||||||||||||||||||
Other comprehensive income |
73 | 73 | ||||||||||||||||||
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Balance as of March 31, 2019 |
624 | 239,656 | 2,667 | (200,292 | ) | 42,655 | ||||||||||||||
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|
|||||||||||
Balance as of January 1, 2020 |
762 | 270,451 | 1,962 | (234,508 | ) | 38,667 | ||||||||||||||
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|||||||||||
Equity-settled share based payment awards |
727 | 727 | ||||||||||||||||||
Loss for the period |
(8,289 | ) | (8,289 | ) | ||||||||||||||||
Other comprehensive income |
81 | 81 | ||||||||||||||||||
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Balance as of March 31, 2020 |
762 | 271,178 | 2,043 | (242,797 | ) | 31,186 | ||||||||||||||
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