Latest News by Industry
HEIDELBERG, Germany, Nov. 15, 2022 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD) (“Affimed” or the “Company”), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results for the third quarter ended September 30, 2022 and provided an update on clinical and corporate progress.
“We are excited to have secured a partner that is able to provide a commercially viable NK cell product that enables us to start a registration directed, multicenter clinical trial in order to bring this promising treatment to patients in need as fast as possible. This collaboration builds on the foundation of the exceptional data of AFM13 in combination with NK cells that will be presented at ASH,” said Dr. Adi Hoess, CEO of Affimed. “The progress we are making across our pipeline has laid the foundation for the next steps of development. We are looking forward to sharing key clinical milestones before the end of this year, including topline data from the REDIRECT study and data from the combination of AFM13 with NK cells.”
Clinical Stage Program Updates
AFM13 (CD30/CD16A)
AFM24 (EGFR/CD16A)
Preclinical Programs
AFM28 (CD123/CD16A)
Affimed’s AFM28 ICE® targets CD16A on NK cells and macrophages, and CD123 on leukemic blasts and leukemic stem cells that are prevalent in acute myeloid leukemia (AML).
Pre-clinical data from a collaboration between Affimed and the Department of Hematology and Oncology, Medical Faculty Mannheim, Heidelberg University will be presented at the ASH conference.
The study evaluated the efficacy of AFM28 in preclinical AML models. In a panel of AML cell lines, AFM28 successfully engaged allogeneic NK cells to destroy CD132-positive tumor cells through antibody-dependent cytotoxicity (ADCC). ADCC induced by AFM28 was independent of leukemic cell mutational profiles and was also effective in targeting cells with low levels of CD123 surface expression.
Residual leukemic stem cells are a frequent cause for relapse and associated with poor prognosis. Patient-derived AML cell cultures incubated with AFM28 and allogeneic NK cells showed significantly reduced numbers of outgrowing colonies compared to controls. That indicates that LSCs and progenitor cells were eliminated. These results were confirmed in an AML mouse model demonstrating complete inhibition of tumor growth throughout a 42-day treatment period in comparison to untreated control mice who all developed systemic disease.
The Company anticipates initiating the phase 1 clinical study for AFM28 in the first half of 2023.
Partnerships and Collaborations
Partnered programs with Genentech and Roivant continue to progress.
Roivant presented a poster at SITC that AFVT-2101/AFM32 represents a novel approach to treating folate receptor alpha (FRα) expressing tumors by engaging the innate immune response for safe and effective tumor cell killing. The company announced that it is expecting to enter phase 1 clinical trial in 2023.
Affimed is eligible for additional proceeds including pre-clinical milestones as well as milestones based on early regulatory achievements.
Third Quarter 2022 Financial Highlights
Affimed's consolidated financial statements are prepared in accordance with International Financial Reporting Standards (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 September 30, 2022, cash and cash equivalents totaled €222.9 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 September 30, 2022, was €19.0 million compared to €25.6 million for the quarter ended September 30, 2021.
Total revenue for the quarter ended September 30, 2022, was €14.9 million compared with €8.7 million for the quarter ended September 30, 2021. Revenue predominately relates to the Genentech and Roivant collaborations.
Research and development expenses for the quarter ended September 30, 2022, increased by 27% from €20.6 million to €26.1 million compared to the quarter ended September 30, 2021. Research and development expenses increased primarily due to higher expenses associated with the development of the AFM13 and AFM24 programs and included costs to produce clinical trial material, clinical patient trial costs and manufacturing, an increase in costs associated with other early-stage programs and infrastructure, and an increase in share-based payment expenses.
General and administrative expenses increased 19% from €6.8 million in the quarter ended September 30, 2021 to €8.1 million in the quarter ended September 30, 2022. The increase predominately relates to an increase in headcount, higher share-based payment expenses, an increase in insurance premiums and higher consulting costs.
Net finance income for the quarter ended September 30, 2022 increased by 84% from €1.5 million in the quarter ended September 30, 2021, to €2.7 million. Net finance income is largely the result of foreign exchange gains related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and the Euro during the year.
Net loss for the quarter ended September 30, 2022, was €16.5 million, or €0.11 loss per common share compared with a net loss of €17.1 million, or €0.14 loss per common share, for the quarter ended September 30, 2021.
The weighted number of common shares outstanding for the quarter ended September 30, 2022 was 149.3 million.
Additional information regarding these results is included in the notes to the consolidated financial statements as of September 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 IASB. 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 November 15, 2022, at 8:30 a.m. EST / 14:30 CET to discuss third quarter 2022 financial results and corporate developments. The conference call will be available via phone and webcast. The live audio webcast of the 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/. To access the call by phone, please use link https://register.vevent.com/register/BI62ec6e16028b424eba578af8c49e4240, and you will be provided with dial-in details and a pin number.
Notes:
To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time.
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 the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, AFM28 and the Company’s other product candidates, the value of its ROCK® platform, its ongoing and planned preclinical development and clinical trials, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which it operates, the trends that may affect the industry or the Company, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict, the fact that the current clinical data of AFM13 in combination with NK cell therapy is based on AFM13 precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AB-101 and other uncertainties and 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 the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.
Investor Relations Contact
Alexander Fudukidis
Director, Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102 Unaudited consolidated interim statements of comprehensive income / (loss)(in € thousand) For the three months ended
September For the nine months ended
September 2022 2021 2022 2021 Revenue 14,888 8,662 30,195 30,028 Other income – net 118 231 642 710Research and development expenses (26,126) (20,621) (65,333) (53,826)General and administrative expenses (8,089) (6,841) (23,509) (16,766) Operating loss (19,209) (18,569) (58,005) (39,854) Finance income / (costs) – net 2,719 1,474 5,443 5,421 Loss before tax (16,490) (17,095) (52,562) (34,433) Income taxes 0 0 (2) (2) Loss for the period (16,490) (17,095) (52,564) (34,435) 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 (73) (3,489) (6,846) (8,838) Other comprehensive income / (loss) (73) (3,489) (6,846) (8,838) Total comprehensive income / (loss) (16,563) (20,584) (59,410) (43,273) Basic and diluted earnings / (loss) per share in € per share (undiluted = diluted) (0.11) (0.14) (0.38) (0.29)Weighted number of common shares outstanding 149,339,335 119,786,695 140,036,614 118,545,453Consolidated interim statements of financial position(in € thousand) September 30, 2022 December 31, 2021 (unaudited) ASSETS Non-current assets Intangible assets 1,555 1,607Leasehold improvements and equipment 3,584 3,814Long-term financial assets 0 12,348Right-of-use assets 710 972 5,849 18,741Current assets Cash and cash equivalents 222,895 197,630Trade and other receivables 1,691 4,809Inventories 673 421Assets held for sale 1,731 0Other assets and prepaid expenses3,560 3,534 230,550 206,394 TOTAL ASSETS 236,399 225,135 EQUITY AND LIABILITIES Equity Issued capital 1,493 1,234Capital reserves 578,390 474,087Fair value reserves (5,954) (5,973)Accumulated deficit (392,826) (333,397)Total equity 181,103 135,951 Non current liabilities Borrowings13,027 17,060Contract liabilities 1,238 7,209Lease liabilities 203 368Total non-current liabilities 14,468 24,637 Current liabilities Trade and other payables 15,078 18,860Borrowings4,957 580Lease liabilities 541 683Contract liabilities20,252 44,424Total current liabilities 40,828 64,547 TOTAL EQUITY AND LIABILITIES 236,399 225,135Unaudited consolidated interim statements of cash flows(in € thousand) For the nine months ended
September 30, 2022 2021Cash flow from operating activities Income / (loss) for the period (52,564) (34,435)Adjustments for the period: - Income taxes 2 2- Depreciation and amortization 1,066 935- Net gain / loss from disposal of leasehold improvements and equipment 0 (2)- Share-based payments 14,779 8,117- Finance income / costs – net (5,443) (5,421) (42,160) (30,804)Change in trade and other receivables 3,118 (1,320)Change in inventories (252) (446)Change in other assets and prepaid expenses (26) 1,064Change in trade, other payables, provisions and contract liabilities (33,888) (26,802) (73,208) (58,308)Interest received 228 0Paid interest (950) (647)Paid income tax (2) (2)Net cash used in operating activities (73,932) (58,957) Cash flow from investing activities Purchase of intangible assets (30) (5)Purchase of leasehold improvements and equipment (263) (1,527)Cash received from the sale of financial assets 3,772 0Net cash used for investing activities 3,479 (1,532) Cash flow from financing activities Proceeds from issue of common shares, including exercise of share-based payment awards 95,907 103,379Transaction costs related to issue of common shares (6,159) (6,548)Proceeds from borrowings 0 10,000Transaction costs related to borrowings 0 (236)Repayment of lease liabilities (538) (372)Repayment of borrowings (70) (69)Cash flow from financing activities 89,140 106,154 Exchange-rate related changes of cash and cash equivalents 6,578 6,223Net changes to cash and cash equivalents 18,687 45,665Cash and cash equivalents at the beginning of the period 197,630 146,854Cash and cash equivalents at the end of the period 222,895 198,742Unaudited consolidated interim statements of changes in equity(in € thousand) Issued
capital Capital
reserves Fair Value
reserves Accumulated
deficit Total
equityBalance as of January 1, 2021 983 345,164 1,720 (275,874) 71,993 Issue of common shares 205 94,138 94,343Exercise of share-based payment awards 10 2,667 2,677Equity-settled share-based payment awards 8,117 8,117Loss for the period (34,435) (34,435)Other comprehensive loss (8,838) (8,838) Balance as of September 30, 2021 1,198 450,086 (7,118) (310,309) 133,857 Balance as of January 1, 2022 1,234 474,087 (5,973) (333,397) 135,951 Issue of common shares 259 89,423 89,682Exercise of share-based payment awards 101 101Equity-settled share-based payment awards 14,779 14,779Transfer of cumulative loss on sale of financial assets 6,865 (6,865) 0Loss for the period (52,564) (52,564)Other comprehensive loss (6,846) (6,846) Balance as of September 30, 2022 1,493 578,390 (5,954) (392,826) 181,103