- 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.
REDIRECT is a phase 2, registration-directed study of AFM13 monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL).
- 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.
As presented at AACR in April 2021, the first four patients showed a 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.
Preclinical data demonstrates that AFM28 induces tumor cell lysis more potently than conventional anti-CD123 antibodies, even at low CD123 expression. Further, AFM28 shows a 100-fold more potent NK cell activation in an ex vivo analysis, compared to Fc-enhanced IgG1 antibodies. In a preclinical toxicology study in cynomolgus monkey, AFM28 was safe and well-tolerated and exhibited the expected pharmacodynamic activity suggesting a good safety profile and the potential to eliminate CD123+ cells in vivo. Clinical investigation of AFM28 is planned to start in second half of 2022.
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
Alexander Fudukidis
Director, Head of Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102
| Affimed N.V. | |||||||||||||
| Unaudited interim consolidated statements of comprehensive income / (loss) (in € thousand) | |||||||||||||
| For the three months ended September 30, | For the nine months ended September 30, | ||||||||||||
| 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 September 30, | ||||||
| 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 | Capital reserves | Fair value reserves | Accumulated deficit | Total equity | |||||||||||||||
| 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 | ||||||||||||
