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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 | |
---|---|---|---|---|---|---|---|---|---|---|
-0.17 | -3.10% | 5.32 | 5.30 | 5.57 | 5.49 | 5.32 | 5.49 | 2,053 | 15:00:00 |
“During the second quarter, we completed a public offering that enables Affimed to invest in its lead programs through key inflection points,” said Dr. Adi Hoess, CEO of Affimed. “The second half of 2022 is shaping up to be very exciting with data updates from AFM13 monotherapy and combination studies and our AFM24 program at scientific conferences.”
Clinical Stage Program Updates
AFM13 (CD30/CD16A)
AFM24 (EGFR/CD16A)
Preclinical Programs
AFM28 (CD123/CD16A)
Preclinical Pipeline
Affimed is continuing to innovate and generate several novel ICE® molecules derived from its proprietary ROCK® platform.
Partnerships and Collaborations
Partnered programs with both Genentech and Roivant continue to progress according to plan. Affimed is eligible for additional proceeds from meeting pre-clinical and early regulatory achievement milestones.
Scientific Advisory Board
During the quarter, the Company established an independent advisory panel made up of distinguished opinion leaders with scientific and clinical expertise in innate immunity and oncology. The Scientific Advisory Board (SAB) will provide guidance on the development strategy across preclinical and clinical development candidates as well as opportunities to apply our platform to cancer indications of high unmet need. All SAB members are leaders in a broad range of areas relevant to Affimed's approach to developing cancer therapies including immuno-oncology, the biology of NK cells, lymphomas, leukemias, and solid tumors.Second Quarter 2022 Financial Highlights
Affimed's consolidated financial statements are prepared in accordance with IFRS as issued by the International Accounting Standard Board (IASB). The consolidated financial statements are presented in euros, the Company's functional and presentation currency. As of June 30, 2022 cash and cash equivalents totaled €237.2 million compared to €197.6 million on December 31, 2021.
Based on the Company’s current operating plan and assumptions, cash and cash equivalents are expected to support operations into mid-2024.
Net cash used in operating activities for the quarter ended June 30, 2022 was €26.5 million compared to €17.3 million for the quarter ended June 30, 2021.
Total revenue for the quarter ended June 30, 2022 was €7.3 million compared with €9.7 million for the quarter ended June 30, 2021. Revenue predominately relates to the Genentech and Roivant collaborations.
Research and development expenses decreased by 4% from €21.8 million in the quarter ended June 30, 2021 to €20.8 million for the quarter ended June 30, 2022. The decrease was primarily due to lower expenses associated with the development of the AFM13 and AFM24 programs, a result of a decrease in procurement of clinical trial material.
General and administrative expenses increased 54% from €5.4 million in the quarter ended June 30, 2021 to €8.4 million in the quarter ended June 30, 2022. The increase predominately relates to higher personnel, higher share-based payment expenses and increased insurance premiums.
Net finance income/(costs) increased from costs of €1.6 million for the quarter ended June 30, 2021 to income of €2.3 million for the quarter ended June 30, 2022. Net finance income/(cost) is largely made up of foreign exchange gains and losses related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and the Euro during the year.
Net loss for the quarter ended June 30, 2022 was €19.4 million, or €0.13 loss per common share compared with a net loss of €18.8 million, or €0.16 loss per common share for the quarter ended June 30, 2021.
The weighted number of common shares outstanding for the quarter ended June 30, 2022 was 147.3 million.
Additional information regarding these results is included in the notes to the consolidated financial statements as of June 30, 2022 which will be included in Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).
Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the 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 on August 11, 2022 at 8:30 a.m. EDT / 14:30 CEST to discuss second quarter 2022 financial results and corporate developments. The conference call will be available via phone and webcast.
To access the call, please dial +1 (866) 374-5140 for U.S. callers, or +1 (404) 400-0571 for international callers, and use PIN: 54780189# approximately 15 minutes prior to the call.
A live audio webcast of the conference call will be available in the “Webcasts” section on the “Investors” page of the Affimed website at https://www.affimed.com/investors/webcasts-and-corporate-presentation/.A replay of the webcast will be accessible at the same link for 30 days following the call.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s proprietary ROCK® platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK® platform predictably generates customized innate cell engager (ICE®) molecules, which use patients’ immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE®. Headquartered in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: www.affimed.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, AFM28 and our other product candidates, the value of our ROCK® platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on our business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict and the risks, uncertainties and other factors described under the heading “Risk Factors” in Affimed’s filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future.
Investor Relations Contact Alexander FudukidisDirector, Investor RelationsE-Mail: a.fudukidis@affimed.comTel.: +1 (917) 436-8102
AFFIMED N.V.
CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS
Unaudited consolidated interim statements of comprehensive income / (loss) | ||||||||||||||||||||
(in € thousand) | ||||||||||||||||||||
For the three months ended June 30 | For the six months ended June 30 | |||||||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||||||
Revenue | 7,301 | 9,707 | 15,307 | 21,366 | ||||||||||||||||
Other income – net | 240 | 332 | 524 | 479 | ||||||||||||||||
Research and development expenses | (20,829 | ) | (21,800 | ) | (39,208 | ) | (33,205 | ) | ||||||||||||
General and administrative expenses | (8,374 | ) | (5,439 | ) | (15,419 | ) | (9,925 | ) | ||||||||||||
Operating loss | (21,662 | ) | (17,200 | ) | (38,796 | ) | (21,285 | ) | ||||||||||||
Finance income / (costs) – net | 2,253 | (1,552 | ) | 2,724 | 3,947 | |||||||||||||||
Loss before tax | (19,409 | ) | (18,752 | ) | (36,072 | ) | (17,338 | ) | ||||||||||||
Income taxes | 0 | 0 | (2 | ) | (2 | ) | ||||||||||||||
Loss for the period | (19,409 | ) | (18,752 | ) | (36,074 | ) | (17,340 | ) | ||||||||||||
Other comprehensive income / (loss) Items that will not be reclassified to profit or lossEquity investments at fair value OCI – net change in fair value | (599 | ) | (4,097 | ) | (6,773 | ) | (5,349 | ) | ||||||||||||
Other comprehensive income / (loss) | (599 | ) | (4,097 | ) | (6,773 | ) | (5,349 | ) | ||||||||||||
Total comprehensive income / (loss) | (20,008 | ) | (22,849 | ) | (42,847 | ) | (22,689 | ) |
Basic and diluted earnings / (loss) per share in € per share (undiluted = diluted) | (0.13 | ) | (0.16 | ) | (0.27 | ) | (0.15 | ) |
Weighted number of common shares outstanding | 147,326,291 | 119,645,207 | 135,385,254 | 117,924,831 |
Consolidated interim statements of financial position | ||||||||
(in € thousand) | ||||||||
June 30, 2022 | December 31, 2021 | |||||||
(unaudited) | ||||||||
ASSETS | ||||||||
Non-current assets | ||||||||
Intangible assets | 1,553 | 1,607 | ||||||
Leasehold improvements and equipment | 3,684 | 3,814 | ||||||
Long-term financial assets | 0 | 12,348 | ||||||
Right-of-use assets | 877 | 972 | ||||||
6,114 | 18,741 | |||||||
Current assets | ||||||||
Cash and cash equivalents | 237,232 | 197,630 | ||||||
Trade and other receivables | 5,524 | 4,809 | ||||||
Inventories | 571 | 421 | ||||||
Assets held for sale | 4,057 | 0 | ||||||
Other assets and prepaid expenses | 7,407 | 3,534 | ||||||
254,791 | 206,394 | |||||||
TOTAL ASSETS | 260,905 | 225,135 | ||||||
EQUITY AND LIABILITIES | ||||||||
Equity | ||||||||
Issued capital | 1,493 | 1,234 | ||||||
Capital reserves | 573,544 | 474,087 | ||||||
Fair value reserves | (9,927 | ) | (5,973 | ) | ||||
Accumulated deficit | (372,290 | ) | (333,397 | ) | ||||
Total equity | 192,820 | 135,951 | ||||||
Non current liabilities | ||||||||
Borrowings | 14,368 | 17,060 | ||||||
Contract liabilities | 1,392 | 7,209 | ||||||
Lease liabilities | 317 | 368 | ||||||
Total non-current liabilities | 16,077 | 24,637 | ||||||
Current liabilities | ||||||||
Trade and other payables | 12,760 | 18,860 | ||||||
Borrowings | 3,498 | 580 | ||||||
Lease liabilities | 613 | 683 | ||||||
Contract liabilities | 35,137 | 44,424 | ||||||
Total current liabilities | 52,008 | 64,547 | ||||||
TOTAL EQUITY AND LIABILITIES | 260,905 | 225,135 |
Unaudited consolidated interim statements of cash flows | |||||||||
(in € thousand) | For the six months ended June 30 | ||||||||
2022 | 2021 | ||||||||
Cash flow from operating activities | |||||||||
Income / (loss) for the period | (36,074 | ) | (17,340 | ) | |||||
Adjustments for the period: | |||||||||
- Income taxes | 2 | 2 | |||||||
- Depreciation and amortization | 703 | 624 | |||||||
- Share-based payments | 9,872 | 4,695 | |||||||
- Finance income / costs – net | (2,724 | ) | (3,947 | ) | |||||
(28,221 | ) | (15,966 | ) | ||||||
Change in trade and other receivables | (715 | ) | (1,324 | ) | |||||
Change in inventories | (150 | ) | (366 | ) | |||||
Change in other assets and prepaid expenses | (3,873 | ) | 924 | ||||||
Change in trade, other payables, provisions and contract liabilities | (21,372 | ) | (16,262 | ) | |||||
(54,331 | ) | (32,994 | ) | ||||||
Interest received | 82 | 0 | |||||||
Paid interest | (653 | ) | (377 | ) | |||||
Paid income tax | (2 | ) | (2 | ) | |||||
Net cash used in operating activities | (54,904 | ) | (33,373 | ) | |||||
Cash flow from investing activities | |||||||||
Purchase of intangible assets | 0 | (5 | ) | ||||||
Purchase of leasehold improvements and equipment | (194 | ) | (1,502 | ) | |||||
Cash received from the sale of financial assets | 1,518 | 0 | |||||||
Net cash used for investing activities | 1,324 | (1,507 | ) | ||||||
Cash flow from financing activities | |||||||||
Proceeds from issue of common shares, including exercise of share-based payment awards | 95,907 | 103,242 | |||||||
Transaction costs related to issue of common shares | (5,894 | ) | (6,447 | ) | |||||
Proceeds from borrowings | 0 | 10,000 | |||||||
Transaction costs related to borrowings | 0 | (236 | ) | ||||||
Repayment of lease liabilities | (352 | ) | (228 | ) | |||||
Repayment of borrowings | (47 | ) | (46 | ) | |||||
Cash flow from financing activities | 89,614 | 106,285 | |||||||
Exchange-rate related changes of cash and cash equivalents | 3,568 | 4,417 | |||||||
Net changes to cash and cash equivalents | 36,034 | 71,405 | |||||||
Cash and cash equivalents at the beginning of the period | 197,630 | 146,854 | |||||||
Cash and cash equivalents at the end of the period | 237,232 | 222,676 |
Unaudited consolidated interim statements of changes in equity(in € thousand)
Issuedcapital | Capitalreserves | Fair Valuereserves | Accumulateddeficit | Totalequity | ||||||||
Balance as of January 1, 2021 | 983 | 345,164 | 1,720 | (275,874 | ) | 71,993 | ||||||
Issue of common shares | 205 | 94,135 | 94,340 | |||||||||
Exercise of share-based payment awards | 9 | 2,531 | 2,540 | |||||||||
Equity-settled share-based payment awards | 4,695 | 4,695 | ||||||||||
Loss for the period | (17,340 | ) | (17,340 | ) | ||||||||
Other comprehensive loss | (5,349 | ) | (5,349 | ) | ||||||||
Balance as of June 30, 2021 | 1,197 | 446,525 | (3,629 | ) | (293,214 | ) | 150,879 | |||||
Balance as of January 1, 2022 | 1,234 | 474,087 | (5,973 | ) | (333,397 | ) | 135,951 | |||||
Issue of common shares | 259 | 89,484 | 89,743 | |||||||||
Exercise of share-based payment awards | 101 | 101 | ||||||||||
Equity-settled share-based payment awards | 9,872 | 9,872 | ||||||||||
Transfer of cumulative loss on sale of financial assets | 2,819 | (2,819 | ) | 0 | ||||||||
Loss for the period | (36,074 | ) | (36,074 | ) | ||||||||
Other comprehensive loss | (6,773 | ) | (6,773 | ) | ||||||||
Balance as of June 30, 2022 | 1,493 | 573,544 | (9,927 | ) | (372,290 | ) | 192,820 |
1 Year Affimed NV Chart |
1 Month Affimed NV Chart |
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