Heidelberg, Germany, August 8, 2018 - Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies that harness the power of innate and adaptive immunity (NK and T cells), today reported financial and operational results for the quarter ended June 30, 2018.
"We are continuing to progress according to plan with all of our pipeline programs. For our most advanced program, AFM13, clinical development is on track and we are in ongoing discussions with clinical and regulatory experts to define future development paths," said Dr. Adi Hoess, Affimed's CEO. "In addition, we are deepening our understanding of the cellular and molecular mechanisms underlying our engagers' activation of innate immune cells for tumor cell killing, which is important for advancement and expansion of our pipeline."
Second Quarter Pipeline Progress
NK cell engager programs
AFM13 (CD30/CD16A)
AFM24 (EGFR/CD16A)
AFM26 (BCMA/CD16A)
NK cell engager opportunities
T cell engager programs
AFM11 (CD19/CD3)
AMV564 (CD33/CD3), developed by Amphivena
Second Quarter Corporate Updates
Financial Highlights
(Figures for the second quarter and six months ended June 30, 2018 and 2017 represent unaudited figures)
Cash and cash equivalents totaled €47.4 million as of June 30, 2018 compared to €39.8 million as of December 31, 2017. The increase was primarily attributable to the net proceeds of €19.7 million from the public offering in February 2018, partially offset by Affimed's operational expenses.
Net cash used in operating activities was €15.2 million for the six months ended June 30, 2018 compared to €13.1 million for the six months ended June 30, 2017. The increase was primarily related to higher cash expenditure for research and development (R&D) in connection with Affimed's clinical development programs.
Revenue for the second quarter of 2018 was €0.2 million compared to €0.5 million for the second quarter of 2017. Revenue in the 2018 period was solely derived from AbCheck services while revenue in the 2017 period relates to Affimed's former collaboration with Amphivena and AbCheck services.
R&D expenses for the second quarter of 2018 were €7.1 million compared to €5.4 million for the second quarter of 2017. The increase was primarily related to higher expenses for AFM13 and AFM11.
G&A expenses for the second quarter of 2018 were slightly higher at €2.2 million compared to €2.0 million for the second quarter of 2017.
Net loss for the second quarter of 2018 was nearly unchanged at €8.0 million, or €0.13 per common share, compared to a net loss of €7.9 million, or €0.18 per common share, for the second quarter of 2017. The increase in operating expenses was offset by finance income of €1.1 million in the second quarter of 2018, whereas finance costs of €1.2 million were shown in the second quarter of 2017.
Note on IFRS Reporting Standards
Affimed prepares and reports the consolidated financial statements and financial information in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles (GAAP) in the United States. Affimed maintains its books and records in Euro.
Conference Call and Webcast Information
Affimed's management will host a conference call to discuss the company's financial results and recent corporate developments today at 8:30 a.m. ET. A webcast of the conference call can be accessed in the "Events" section on the "Investors & Media" page of the Affimed website at http://www.affimed.com/events.php. A replay of the webcast will be available on Affimed's website shortly after the conclusion of the call and will be archived on the Affimed website for 30 days following the call.
About Affimed N.V.
Affimed (Nasdaq: AFMD) engineers targeted immunotherapies, seeking to cure patients by harnessing the power of innate and adaptive immunity (NK and T cells). We are developing single and combination therapies to treat cancers and other life-threatening diseases. For more information, please visit www.affimed.com.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "look forward to", "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the value of our ROCK(TM) 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, expectations regarding 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 and the risks uncertainties and other factors described under the heading "Risk Factors" in Affimed's filings with the Securities and Exchange Commission. 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.
Affimed Investor Contact:
Gregory Gin, Head of Investor Relations
E-Mail: IR@affimed.com
Affimed Media Contact:
Anca Alexandru, Head of Communications, EU IR
E-Mail: A.Alexandru@affimed.com
AFFIMED N.V.
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Affimed N.V.
Unaudited consolidated statements of comprehensive loss (in € thousand)
For the three months ended June 30 | For the six months ended June 30 | |||||||||
2017 | 2018 | 2017 | 2018 | |||||||
Revenue | 508 | 150 | 907 | 682 | ||||||
Other income - net | 93 | 49 | 84 | 38 | ||||||
Research and development expenses | (5,431) | (7,149) | (10,873) | (13,545) | ||||||
General and administrative expenses | (1,969) | (2,164) | (4,215) | (4,202) | ||||||
Operating loss | (6,799) | (9,114) | (14,097) | (17,027) | ||||||
Finance income / (costs) - net | (1,169) | 1,100 | (1,625) | 811 | ||||||
Loss before tax | (7,968) | (8,014) | (15,722) | (16,216) | ||||||
Income taxes | 21 | 0 | 20 | (1) | ||||||
Loss for the period | (7,947) | (8,014) | (15,702) | (16,217) | ||||||
Other comprehensive income | ||||||||||
Items that will not be reclassified to profit or loss | ||||||||||
Equity investments at fair value OCI - net change in fair value | 0 | 406 | 0 | 211 | ||||||
Other comprehensive income | 0 | 406 | 0 | 211 | ||||||
Total comprehensive loss | (7,947) | (7,608) | (15,702) | (16,006) | ||||||
Loss per share in € per share (undiluted = diluted) | (0.18) | (0.13) | (0.37) | (0.28) |
Affimed N.V.
Consolidated statements of financial position (in € thousand)
December 31, 2017 | June 30, 2018 | ||
(unaudited) | |||
ASSETS | |||
Non-current assets | |||
Intangible assets | 65 | 72 | |
Leasehold improvements and equipment | 1,113 | 1,230 | |
Long term financial assets | 0 | 7,536 | |
1,178 | 8,838 | ||
Current assets | |||
Inventories | 241 | 267 | |
Trade and other receivables | 1,102 | 1,024 | |
Other assets | 800 | 1,974 | |
Cash and cash equivalents | 39,837 | 47,412 | |
41,980 | 50,677 | ||
TOTAL ASSETS | 43,158 | 59,515 | |
EQUITY AND LIABILITIES | |||
Equity | |||
Issued capital | 468 | 624 | |
Capital reserves | 213,778 | 237,905 | |
Other reserves | 0 | 7,536 | |
Accumulated deficit | (182,667) | (198,884) | |
Total equity | 31,579 | 47,181 | |
Non-current liabilities | |||
Borrowings | 4,086 | 2,869 | |
Total non-current liabilities | 4,086 | 2,869 | |
Current liabilities | |||
Trade and other payables | 4,180 | 5,926 | |
Borrowings | 3,083 | 3,083 | |
Contract liabilities | 230 | 456 | |
Total current liabilities | 7,493 | 9,465 | |
TOTAL EQUITY AND LIABILITIES | 43,158 | 59,515 |
Affimed N.V.
Unaudited consolidated statements of cash flows (in € thousand)
For the six months ended June 30 | ||||
2017 | 2018 | |||
Cash flow from operating activities | ||||
Loss for the period | (15,702) | (16,217) | ||
Adjustments for the period: | ||||
- Income taxes | (20) | 1 | ||
- Depreciation and amortization | 169 | 199 | ||
- Gain from disposal of leasehold improvements and equipment | (20) | 0 | ||
- Share based payments | 1,018 | 937 | ||
- Finance income / costs - net | 1,625 | (811) | ||
(12,930) | (15,891) | |||
Change in trade and other receivables | (250) | 88 | ||
Change in inventories | (53) | (26) | ||
Change in other assets | (404) | (1,159) | ||
Change in trade, other payables and contract liabilities | 657 | 1,970 | ||
Cash used in operating activities | (12,980) | (15,018) | ||
Interest received | 25 | 58 | ||
Paid interest | (128) | (196) | ||
Net cash used in operating activities | (13,083) | (15,156) | ||
Cash flow from investing activities | ||||
Purchase of intangible assets | (23) | (26) | ||
Purchase of leasehold improvements and equipment | (349) | (298) | ||
Cash received from the sale of leasehold improvements and equipment | 18 | 1 | ||
Cash paid for investments in financial assets | (4,655) | 0 | ||
Cash received from maturity of financial assets | 9,209 | 0 | ||
Net cash used for investing activities | 4,200 | (323) | ||
Cash flow from financing activities | ||||
Proceeds from issue of common shares | 17,901 | 25,042 | ||
Transaction costs related to issue of common shares | (1,481) | (1,686) | ||
Proceeds from borrowings | 2,500 | 0 | ||
Transaction costs related to borrowings | (11) | 0 | ||
Repayment of borrowings | 0 | (1,500) | ||
Cash flow from financing activities | 18,909 | 21,856 | ||
Exchange-rate related changes of cash and cash equivalents | (947) | 1,198 | ||
Net changes to cash and cash equivalents | 10,026 | 6,377 | ||
Cash and cash equivalents at the beginning of the period | 35,407 | 39,837 | ||
Cash and cash equivalents at the end of the period | 44,486 | 47,412 |
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, 2017 | 333 | 190,862 | 0 | (152,444) | 38,751 | ||||
Issue of common shares | 106 | 15,910 | 16,016 | ||||||
Equity-settled share based payment awards | 1,018 | 1,018 | |||||||
Issue of warrant note (loan Silicon Valley Bank) | 51 | | 51 | ||||||
Loss for the period | (15,702) | (15,702) | |||||||
Balance as of June 30, 2017 | 439 | 207,841 | 0 | (168,146) | 40,134 | ||||
Revaluation shares Amphivena (first time adoption IFRS 9) | 7,325 | 7,325 | |||||||
Balance as of January 1, 2018 | 468 | 213,778 | 7,325 | (182,667) | 38,904 | ||||
Issue of common shares | 156 | 23,190 | 23,346 | ||||||
Equity-settled share based payment awards | 937 | 937 | |||||||
Loss for the period | (16,217) | (16,217) | |||||||
Other comprehensive income | 211 | 211 | |||||||
Balance as of June 30, 2018 | 624 | 237,905 | 7,536 | (198,884) | 47,181 |