Affimed Reports Third Quarter 2021 Financial Results and Highlights Operational Progress
11/10/2021 - 06:30 AM
AFM13 monotherapy: Enrollment is on track and expected to be completed in the first half of 2022. AFM13 combination with NK cells: Updated data to be presented at company-sponsored event in mid-December 2021. AFM24 monotherapy: Identified recommended Phase 2 dose (480 mg weekly); expansion cohorts to open during the fourth quarter of 2021. AFM24 combination with anti PD-L1 checkpoint inhibitor: Clinical trial of AFM24 with atezolizumab (Tecentriq® ) on track to start in fourth quarter of 2021. AFM24 combination with NK cells: Initiated recruitment for the clinical trial of AFM24 in combination with NKGen Biotech’s SNK01 NK cell therapy. AFM28: AFM28 targets CD123, which is universally expressed on blasts and leukemic stem cells (LSCs) in AML. Initial preclinical data to be presented at American Society of Hematology conference in December 2021. Cash and cash equivalents as of September 30, 2021, were approximately €198.7 million with anticipated cash runway into the second half of 2023. Conference call and webcast scheduled for November 10, 2021, at 8:30 a.m. EST. HEIDELBERG, Germany, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today reported financial results for the quarter ended September 30, 2021, and provided an update on clinical and corporate progress.
“In the past months, we have significantly expanded our efforts to ensure the development of our leading candidates, AFM13 and AFM24, which we believe will result in multiple catalysts over the next several quarters,” said Adi Hoess, CEO of Affimed. “We are excited about AFM28, a ROCK® platform-based ICE® , which we believe will be a novel and promising approach for difficult-to-treat AML patients. We know NK cells have shown some activity in AML and, coupled with what we are seeing in the AFM13 study in combination with NK cells we are hopeful that this highly differentiated product candidate will offer a new treatment option to those patients currently left behind,” he concluded.
Clinical Stage Program Updates
AFM13 (CD30/CD16A)
Affimed is continuing to recruit patients in the REDIRECT study (AFM13-202) after reporting positive results from the preplanned interim futility analysis in March 2021; based on this successful interim analysis, the high- and low-CD30 expressing cohorts of this trial have been combined into one. Affimed expects to complete enrollment in the study in the first half of 2022. Affimed reported that there were no dose-limiting toxicities observed in the dose escalation part of the investigator sponsored study (IST) at The University of Texas MD Anderson Cancer Center. The study, which is investigating the treatment of CD30-positive lymphoma patients with AFM13 precomplexed cord blood-derived natural killer (NK) cells (AFM13-104), continues to enroll patients at the highest dose level. As of October 31, 2021, 18 patients had been treated in the study, including 12 patients at the highest NK cell dose. An amendment to the protocol for the study has been submitted to allow for the enrollment of up to 40 patients at the highest dose level to generate additional data on safety and efficacy. The expansion would include patients with Hodgkin Lymphoma and non-Hodgkin Lymphoma.100% objective response rate with two out of four patients (50% ) achieving a complete response. Affimed expects to present additional data from the study at a company-sponsored event in December 2021. AFM24 (EGFR/CD16A)
For AFM24, an EGFR/CD16A targeted innate cell engager (ICE® ) for patients with EGFR-expressing solid tumors, Affimed is executing a strategy intended to deliver the highest probability of success. As such, the objective is to treat patients with EGFR-expressing tumors with AFM24 as monotherapy (AFM24-101) in 3 indications, with AFM24 in combination with an anti-PD-L1 antibody (AFM24-102) in at least 3 indications and with AFM24 in combination with autologous NK cells in 3 indications (AFM24-103). In AFM24-101, the monotherapy phase 1/2a clinical trial, a weekly dose of 480 mg has been identified as the recommended phase 2 dose based on a comprehensive review of safety, pharmacokinetic and pharmacodynamic data, including exposure and NK cell CD16A receptor occupancy. Of note, four out of six patients dosed in the 480 mg cohort remain on therapy based on investigator assessment of clinical benefit; two of these patients have demonstrated stable disease beyond three months and continue on treatment. Affimed expects to start the dose expansion phase of the trial at the recommended phase 2 dose in the fourth quarter of 2021. The trial will include the following indications:Renal cell carcinoma (clear cell), failing standard of care (SoC) including TKIs and PD1 targeted therapy Non-small cell lung cancer (EGFR-mutant), failing SoC TKIs and PD1 naïve; and, Colorectal cancer, failing chemotherapy plus EGFR-targeted antibodies In parallel, Affimed will continue to evaluate higher doses of AFM24 to generate additional safety data, and enrollment has begun in a cohort to evaluate a weekly dose of 720 mg.
AFM24-102, the phase 1/2a combination study of AFM24 with the PD-L1 checkpoint inhibitor atezolizumab (Tecentriq® ) in EGFR-expressing solid tumors, is on track to start in the fourth quarter of 2021. The combination trial will include the following indications: Non-small cell lung cancer (EGFR-wildtype), failing chemotherapy and PD1 targeted therapy Gastric/gastroesophageal junction (GEJ) cancer failing chemotherapy and/or PD1 targeted therapy; and, A basket of EGFR-expressing tumors comprising pancreatic, hepatocellular and biliary tract cancer failing standard of care therapy for the respective disease AFM24-103, the phase 1/2a combination study of AFM24 with NKGen Biotech’s autologous NK cell therapy, SNK01, a first-in-human proof of concept trial in EGFR-expressing solid tumors, is now open to recruit patients. As previously announced, the combination trial will include the following indications: Non-small cell lung cancer (EGFR-wildtype), failing chemotherapy and PD1 targeted therapy Squamous cell carcinoma of the head and neck, failing chemotherapy and PD1 targeted therapy; and, Colorectal cancer including those with mutations, failing standard of care therapy Preclinical Program
AFM28 (CD123/CD16A)
Preclinical candidate AFM28, developed on the company’s proprietary ROCK® platform, is a bispecific, tetravalent ICE® that targets CD16A on NK cells and macrophages, as well as CD123 on leukemic cells and leukemic stem cells that are prevalent in AML. The high affinity to CD16 and CD123 initiates antibody-dependent cell-mediated cytotoxicity (ADCC) against CD123+ tumor cells. Third Quarter 2021 Financial Highlights
(Figures for the quarters ended September 30, 2021, and 2020 are unaudited.)
As of September 30, 2021, cash and cash equivalents totaled €198.7 million compared to €146.9 million on December 31, 2020. Based on its current operating plan and assumptions, Affimed anticipates that its cash and cash equivalents will support operations into the second half of 2023.
Net cash used in operating activities for the quarter ended September 30, 2021 was €25.6 million compared to €3.6 million for the quarter ended September 30, 2020.
Total revenue for the quarter ended September 30, 2021, was €8.7 million compared with €10.5 million for the quarter ended September 30, 2020. Revenue predominately relates to the Genentech and Roivant collaborations.
Research and development expenses for the quarter ended September 30, 2021 amounted to €20.6 million compared to €10.1 million for the quarter ended September 30, 2020. The increase is largely due to increased costs for AFM24, including costs associated with the ongoing phase 1/2a clinical trial and manufacturing costs for clinical trial material required for the ongoing study and planned future studies, as well as an increase in costs associated with early-stage development/discovery activities. In addition, there was an increase associated with research and development that is non-project specific, including share-based payment expense, intellectual property-related expenses and facility costs.
General and administrative expenses were €6.8 million in the quarter ended September 30, 2021, compared to €3.5 million in the quarter ended September 30, 2020. The increase relates largely to higher personnel expenses due to an increase in headcount, higher premiums for our Directors and Officers liability insurance, increase in share-based payment expense and higher legal and consulting expenses.
Net finance income for the quarter ended September 30, 2021 was €1.5 million compared to net finance loss of €3.1 million in the quarter ended September 30, 2020. Net finance income/loss is largely due to foreign exchange gains/losses related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and Euro during the quarter.
Net loss for the quarter ended September 30, 2021 was €17.1 million , or loss of €0.14 per common share, compared with a net loss of €6.0 million , or €0.07 loss per common share, for the quarter ended September 30, 2020.
The weighted number of common shares outstanding for the quarter ended September 30, 2021 was 119.8 million.
Additional information regarding these results will be included in the notes to the consolidated financial statements as of September 30, 2021, of 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 today, November 10, 2021, at 8:30 a.m. EST to discuss third quarter 2021 financial results and recent corporate developments. The conference call will be available via phone and webcast.
To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference passcode 6166004 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 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 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 a.fudukidis@affimed.com
Affimed N.V. Unaudited interim consolidated statements of comprehensive income / (loss) (in € thousand) For the three months ended For the nine months ended 2021 2020 2021 2020 Revenue 8,662 10,545 30,028 18,614 Other income/(expenses) - net 231 102 710 130 Research and development expenses (20,621 ) (10,101 ) (53,826 ) (33,247 ) General and administrative expenses (6,841 ) (3,455 ) (16,766 ) (9,586 ) Operating income / (loss) (18,569 ) (2,909 ) (39,854 ) (24,089 ) Finance income / (costs) - net 1,474 (3,057 ) 5,421 (2,404 ) Loss before tax (17,095 ) (5,966 ) (34,433 ) (26,493 ) Income taxes - - (2 ) - Loss for the period (17,095 ) (5,966 ) (34,435 ) (26,493 ) 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 (3,489 ) (139 ) (8,838 ) (129 ) Other comprehensive income / (loss) (3,489 ) (139 ) (8,838 ) (129 ) Total comprehensive loss (20,584 ) (6,105 ) (43,273 ) (26,622 ) Loss per share in € per share (0.14 ) (0.07 ) (0.29 ) (0.33 ) (undiluted = diluted) Weighted number of common shares outstanding 119,786,695 86,030,878 118,545,453 80,490,155
Affimed N.V. Interim consolidated statements of financial position (in € thousand) September 30, 2021 December 31, 2020 (unaudited) ASSETS Non-current assets Intangible assets 1,634 1,718 Leasehold improvements and equipment 3,332 2,226 Long term financial assets 11,204 20,042 Right-of-use assets 894 940 17,064 24,926 Current assets Cash and cash equivalents 198,742 146,854 Trade and other receivables 3,759 2,439 Inventories 692 246 Other assets 78 1,260 203,271 150,799 TOTAL ASSETS 220,335 175,725 EQUITY AND LIABILITIES Equity Issued capital 1,198 983 Capital reserves 450,086 345,164 Fair value reserves (7,118 ) 1,720 Accumulated deficit (310,309 ) (275,874 ) Total equity 133,857 71,993 Non-current liabilities Borrowings 10,073 231 Contract liabilities 9,800 35,992 Lease liabilities 314 482 Total non-current liabilities 20,187 36,705 Current liabilities Trade and other payables 13,716 11,394 Borrowings 94 92 Lease liabilities 666 492 Contract liabilities 51,815 55,049 Total current liabilities 66,291 67,027 TOTAL EQUITY AND LIABILITIES 220,335 175,725
Affimed N.V. Unaudited interim consolidated statements of cash flows (in € thousand) For the nine months ended 2021 2020 Cash flow from operating activities Loss for the period (34,435 ) (26,493 ) Adjustments for the period: - Income taxes 2 - - Depreciation and amortisation 935 821 - Net gain / loss from disposal of leasehold improvements and equipment (2 ) - - Share based payments 8,117 2,348 - Finance income / costs – net (5,421 ) 2,404 (30,804 ) (20,920 ) Change in trade and other receivables (1,320 ) (1,174 ) Change in inventories (446 ) (114 ) Change in other assets 1,064 (1,087 ) Change in trade, other payables, provisions and contract liabilities (26,802 ) (12,053 ) Cash used in operating activities (58,308 ) (35,348 ) Interest received - 299 Paid interest (647 ) (81 ) Paid income tax (2 ) - Net cash used in operating activities (58,957 ) (35,130 ) Cash flow from investing activities Purchase of intangible assets (5 ) (8 ) Purchase of leasehold improvements and equipment (1,527 ) (352 ) Cash paid for investments in financial assets - (8,101 ) Cash received from maturity of financial assets - 9,088 Net cash used for investing activities (1,532 ) 627 Cash flow from financing activities Proceeds from issue of common shares, including exercise of share based payment awards 103,379 33,846 Transaction costs related to issue of common shares (6,548 ) (1,134 ) Proceeds from borrowings 10,000 - Transaction costs related to borrowings (236 ) - Repayment of lease liabilities (372 ) (386 ) Repayment of borrowings (69 ) (1,151 ) Cash flow from financing activities 106,154 31,175 Exchange-rate related changes of cash and cash equivalents 6,223 (2,250 ) Net changes to cash and cash equivalents 45,665 (3,328 ) Cash and cash equivalents at the beginning of the period 146,854 95,234 Cash and cash equivalents at the end of the period 198,742 89,656
Affimed N.V. Unaudited interim consolidated statements of changes in equity (in € thousand) Issued Capital Fair Accumulated Total Balance as of January 1, 2020 762 270,451 1,962 (234,508 ) 38,667 Issue of common shares 121 32,502 32,623 Equity-settled share based payment awards 2,348 2,348 Loss for the period (26,493 ) (26,493 ) Other comprehensive income (129 ) (129 ) Balance as of September 30, 2020 883 305,301 1,833 (261,001 ) 47,016 Balance as of January 1, 2021 983 345,164 1,720 (275,874 ) 71,993 Issue of common shares 205 94,138 94,343 Exercise of share based payment awards 10 2,667 2,677 Equity-settled share based payment awards 8,117 8,117 Loss 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
