We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Affimed NV | NASDAQ:AFMD | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.12 | 2.26% | 5.42 | 5.31 | 5.79 | 5.51 | 5.10 | 5.42 | 82,327 | 00:39:13 |
- AFM13: Encouraging data supports initiation of monotherapy registration-directed study in first half of 2019; Combination study with cord blood-derived natural killer cells planned to initiate at MD Anderson; Clinical data updates from monotherapy study and combination study with Keytruda® (pembrolizumab) expected in 2019 -
- AFM24: IND submission planned for mid-2019; Plans to initiate first-in-human study in second half of 2019 -
- AFM11: Submitted all documents as requested by FDA in an effort to resume the AFM11 clinical program in ALL -
Heidelberg, Germany, March 27, 2019 - Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, today provided an update on recent operational progress and reported financial results for the year ended December 31, 2018.
“2018 was a year in which Affimed made substantial progress. We achieved tremendous clinical and corporate milestones that further demonstrated our innate immunity expertise and the potential for therapeutics based on our novel CD16A-targeting innate cell engager approach to treat cancer,” said Dr. Adi Hoess, Affimed’s CEO. “With our current financial resources, including funds received from Genentech under our collaboration, we believe we are well-positioned to achieve additional milestones in 2019 and beyond, including advancing our lead development candidate, AFM13, into a market registration-directed study and entering the clinic with AFM24, our second innate cell engager and a potential treatment for multiple solid tumor malignancies.”
Anticipated 2019 Milestones
Key Pipeline Updates
CD16A innate cell engager programs
AFM13 (CD30/CD16A)
AFM24 (EGFR/CD16A)
T cell engager programs
AFM11 (CD19/CD3)
2018 Corporate Updates
2018 Financial Highlights
Cash, cash equivalents and current financial assets totaled €108.8 million as of December 31, 2018 compared to €39.8 million as of December 31, 2017. Affimed anticipates that its cash, cash equivalents and current financial assets as of December 31, 2018 will enable the Company to fund its operations, including clinical development and early development activities, into 2021 assuming all of the Company’s programs advance as currently contemplated.
Net cash from operating activities was €49.4 million for the twelve months ended December 31, 2018 compared to net cash used in operating activities of €25.5 million for the twelve months ended December 31, 2017. The amount in 2018 includes an initial upfront payment and committed funding of €83.2 million from the Genentech collaboration.
Affimed recognized €21.8 million as revenue from the Genentech collaboration in 2018 and €61.4 million under contract liabilities, which will be recognized as revenue in subsequent periods. Total revenue was €23.7 million for the year ended December 31, 2018 compared to €2.0 million for the year ended December 31, 2017.
Research and development (R&D) expenses were €35.1 million for the year ended December 31, 2018 compared to €21.5 million for the year ended December 31, 2017. The increase was related to higher expenses for AFM13 and AFM11 clinical development activities, as well as early stage development and discovery activities.
General and administrative (G&A) expenses were €9.6 million for the year ended December 31, 2018, compared to €8.0 million for the year ended December 31, 2017. This increase was primarily related to higher legal and consulting expenses.
Net loss was €19.5 million, or €0.32 per common share, for the year ended December 31, 2018, compared to a net loss of €30.2 million, or €0.69 per common share, for the year ended December 31, 2017. The decrease in net loss was primarily related to significantly increased revenue, partially offset by higher spending on R&D and G&A expenses.
Additional information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2018 and “Item 5. Operating and Financial Review and Prospects,” which will be included in Affimed’s Annual Report on Form 20-F as filed with the U.S. Securities and Exchange Commission (SEC).
Note on IFRS Reporting StandardsAffimed 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 will host a conference call and webcast today, Wednesday, March 27, 2019 at 8:30 a.m. Eastern time to discuss the Company’s financial results and recent corporate developments. To access the call, please dial +1 (631) 510-7495 for U.S. callers, or +44 (0) 2071 928000 for international callers, and reference conference ID 5559486 approximately 15 minutes prior to the call. An audio webcast of the conference call can be accessed in the “Webcasts” section on the “Investors” page of the Affimed website at https://www.affimed.com/investors/webcasts/. A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived for 30 days following the call.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical stage biopharmaceutical company committed to giving back patients back their innate ability to fight cancer. Affimed’s fit-for-purpose ROCK® platform allows innate immune engagers to be designed for specific patient populations. The Company is developing single and combination therapies to treat cancers. 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® 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 RelationsE-Mail: IR@affimed.com
Affimed Media Contact:Anca Alexandru, Head of Communications, EU IRE-Mail: media@affimed.com
Affimed N.V. | |||||||||||||||
Consolidated statements of comprehensive loss | |||||||||||||||
(in € thousand) | |||||||||||||||
2018 | 2017 | 2016 | |||||||||||||
Revenue | 23,735 | 2,010 | 6,314 | ||||||||||||
Other income – net | 1,515 | 205 | 145 | ||||||||||||
Research and development expenses | (35,148 | ) | (21,489 | ) | (30,180 | ) | |||||||||
General and administrative expenses | (9,638 | ) | (7,986 | ) | (8,323 | ) | |||||||||
Operating loss | (19,536 | ) | (27,260 | ) | (32,044 | ) | |||||||||
Finance income / (costs) - net | 60 | (2,983 | ) | (230 | ) | ||||||||||
Loss before tax | (19,476 | ) | (30,243 | ) | (32,274 | ) | |||||||||
Income taxes | (1 | ) | 20 | 58 | |||||||||||
Loss for the period | (19,477 | ) | (30,223 | ) | (32,216 | ) | |||||||||
Other comprehensive income Items thatwill not be reclassified to profit or lossEquity investments at fair value OCI – net change in fair value | (4,731 | ) | 0 | 0 | |||||||||||
Other comprehensive income | (4,731 | ) | 0 | 0 | |||||||||||
Total comprehensive loss | (24,208 | ) | (30,223 | ) | (32,216 | ) | |||||||||
Loss per share in € per share | (0.32 | ) | (0.69 | ) | (0.97 | ) | |||||||||
(undiluted = diluted) | |||||||||||||||
Weighted number of common shares outstanding | 60,514,407 | 43,746,073 | 33,259,505 |
Affimed N.V. | ||||||
Consolidated statements of financial position | ||||||
(in € thousand) | ||||||
December 31, 2018 | December 31, 2017 | |||||
ASSETS | ||||||
Non-current assets | ||||||
Intangible assets | 56 | 65 | ||||
Leasehold improvements and equipment | 1,414 | 1,113 | ||||
Long term financial assets | 3,825 | 0 | ||||
5,295 | 1,178 | |||||
Current assets | ||||||
Cash and cash equivalents | 94,829 | 39,837 | ||||
Financial assets | 13,974 | 0 | ||||
Trade and other receivables | 1,429 | 1,102 | ||||
Inventories | 260 | 241 | ||||
Other assets | 387 | 800 | ||||
110,879 | 41,980 | |||||
TOTAL ASSETS | 116,174 | 43,158 | ||||
EQUITY AND LIABILITIES | ||||||
Equity | ||||||
Issued capital | 624 | 468 | ||||
Capital reserves | 239,055 | 213,778 | ||||
Fair value reserves | 2,594 | 0 | ||||
Accumulated deficit | (202,144 | ) | (182,667 | ) | ||
Total equity | 40,129 | 31,579 | ||||
Non current liabilities | ||||||
Borrowings | 1,690 | 4,086 | ||||
Contract liabilities | 37,512 | 0 | ||||
Total non-current liabilities | 39,202 | 4,086 | ||||
Current liabilities | ||||||
Trade and other payables | 9,425 | 4,180 | ||||
Borrowings | 3,083 | 3,083 | ||||
Contract liabilities | 24,335 | 230 | ||||
Total current liabilities | 36,843 | 7,493 | ||||
TOTAL EQUITY AND LIABILITIES | 116,174 | 43,158 |
Affimed N.V. | |||||||||||||||
Consolidated statements of cash flows | |||||||||||||||
(in € thousand) | |||||||||||||||
2018 | 2017 | 2016 | |||||||||||||
Cash flow from operating activities | |||||||||||||||
Loss for the period | (19,477 | ) | (30,223 | ) | (32,216 | ) | |||||||||
Adjustments for the period: | |||||||||||||||
- Income taxes | 1 | (20 | ) | (58 | ) | ||||||||||
- Depreciation and amortisation | 403 | 351 | 369 | ||||||||||||
- Gain from disposal of leasehold improvements and equipment | 25 | (19 | ) | 0 | |||||||||||
- Share based payments | 2,035 | 1,943 | 3,545 | ||||||||||||
- Finance income / (costs) - net | (60 | ) | 2,983 | 230 | |||||||||||
(17,073 | ) | (24,985 | ) | (28,130 | ) | ||||||||||
Change in trade and other receivables | (322 | ) | 1,140 | (1,311 | ) | ||||||||||
Change in inventories | (19 | ) | (44 | ) | 31 | ||||||||||
Change in other assets | 121 | (399 | ) | (64 | ) | ||||||||||
Change in trade, other payables and contract liabilities | 66,856 | (1,018 | ) | (2,177 | ) | ||||||||||
Cash from / (used in) operating activities | 49,563 | (25,306 | ) | (31,651 | ) | ||||||||||
Interest received | 218 | 106 | 102 | ||||||||||||
Paid interest | (342 | ) | (349 | ) | (578 | ) | |||||||||
Paid income tax | (1 | ) | 0 | 0 | |||||||||||
Net cash from / (used in) operating activities | 49,438 | (25,549 | ) | (32,127 | ) | ||||||||||
Cash flow from investing activities | |||||||||||||||
Purchase of intangible assets | (30 | ) | (43 | ) | (21 | ) | |||||||||
Purchase of leasehold improvements and equipment | (691 | ) | (625 | ) | (238 | ) | |||||||||
Cash received from the sale of leasehold improvements and equipment | 1 | 35 | 0 | ||||||||||||
Cash paid for investments in convertible note and warrants | 0 | (296 | ) | 0 | |||||||||||
Cash paid for investments in financial assets | (14,029 | ) | (13,084 | ) | (27,037 | ) | |||||||||
Cash received from maturity of financial assets | 0 | 22,063 | 18,147 | ||||||||||||
Cash paid for investments in long term financial assets | (861 | ) | 0 | 0 | |||||||||||
Net cash from / (used for) investing activities | (15,610 | ) | 8,050 | (9,149 | ) | ||||||||||
Cash flow from financing activities | |||||||||||||||
Proceeds from issue of common shares | 25,113 | 23,123 | 6 | ||||||||||||
Transaction costs related to issue of common shares | (1,701 | ) | (1,648 | ) | 0 | ||||||||||
Proceeds from borrowings | 0 | 2,500 | 5,000 | ||||||||||||
Transaction costs related to borrowings | 0 | (11 | ) | (105 | ) | ||||||||||
Repayment of borrowings | (2,917 | ) | (167 | ) | (5,137 | ) | |||||||||
Cash flow from / (used for) financing activities | 20,495 | 23,797 | (236 | ) | |||||||||||
Exchange-rate related changes of cash and cash equivalents | 669 | (1,867 | ) | 179 | |||||||||||
Net changes to cash and cash equivalents | 54,323 | 6,297 | (41,512 | ) | |||||||||||
Cash and cash equivalents at the beginning of the period | 39,837 | 35,407 | 76,740 | ||||||||||||
Cash and cash equivalents at the end of the period | 94,829 | 39,837 | 35,407 |
Affimed N.V. | |||||||||||||||||||||||||||||||||||||
Consolidated statements of changes in equity | |||||||||||||||||||||||||||||||||||||
(in € thousand) | |||||||||||||||||||||||||||||||||||||
Issued capital | Capital reserves | Fair value reserves | Accumulated deficit | Total equity | |||||||||||||||||||||||||||||||||
Balance as of January 1, 2016 | 333 | 187,169 | 0 | (120,228 | ) | 67,274 | |||||||||||||||||||||||||||||||
Issue of common shares1 | 0 | 6 | 6 | ||||||||||||||||||||||||||||||||||
Equity-settled share based payment awards | 3,545 | 3,545 | |||||||||||||||||||||||||||||||||||
Issue of warrant note (Perceptive loan) | 142 | 142 | |||||||||||||||||||||||||||||||||||
Loss for the period | (32,216 | ) | (32,216 | ) | |||||||||||||||||||||||||||||||||
Balance as of December 31, 2016 | 333 | 190,862 | 0 | (152,444 | ) | 38,751 | |||||||||||||||||||||||||||||||
Balance as of January 1, 2017 | 333 | 190,862 | 0 | (152,444 | ) | 38,751 | |||||||||||||||||||||||||||||||
Issue of common shares | 135 | 20,922 | 21,057 | ||||||||||||||||||||||||||||||||||
Equity-settled share based payment awards | 1,943 | 1,943 | |||||||||||||||||||||||||||||||||||
Issue of warrant note (loan Silicon Valley Bank) | 51 | 51 | |||||||||||||||||||||||||||||||||||
Loss for the period | (30,223 | ) | (30,223 | ) | |||||||||||||||||||||||||||||||||
Balance as of December 31, 2017 | 468 | 213,778 | 0 | (182,667 | ) | 31,579 | |||||||||||||||||||||||||||||||
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 | 23,171 | 23,327 | ||||||||||||||||||||||||||||||||||
Exercise of share based payment awards | 71 | 71 | |||||||||||||||||||||||||||||||||||
Equity-settled share based payment awards | 2,035 | 2,035 | |||||||||||||||||||||||||||||||||||
Loss for the period | (19,477 | ) | (19,477 | ) | |||||||||||||||||||||||||||||||||
Other comprehensive income | (4,731 | ) | (4,731 | ) | |||||||||||||||||||||||||||||||||
Balance as of December 31, 2018 | 624 | 239,055 | 2,594 | (202,144 | ) | 40,129 |
1 Issue of 3,341 shares
1 Year Affimed NV Chart |
1 Month Affimed NV Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions