On March 28, 2024 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, reported financial results and provided an update on clinical and corporate progress for the year ended December 31, 2023 (Press release, Affimed, MAR 28, 2024, View Source [SID1234641553]).

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"The clinical achievements in 2023 with our three programs, AFM24, acimtamig, and AFM28, provide a strong foundation for us to deliver on meaningful clinical milestones across the portfolio in 2024 and beyond," said Dr. Andreas Harstrick, Chief Medical Officer and interim Chief Executive Officer at Affimed. "We have seen compelling responses in treatment refractory NSCLC EGFR-wt patients and will report mature PFS data of these patients as well as response data from the NSCLC EGFR-mut cohort in the second quarter. With the LuminICE-203 study of acimtamig with AlloNK successfully launched in 2023, we are progressing toward an initial data update in the second quarter. The long-term follow-up data for study for the AFM13-104, presented at ASH (Free ASH Whitepaper), demonstrating that approximately 30% of patients remain in remission beyond 1 year, have further enhanced our confidence in the therapeutic potential of acimtamig in combination with NK cells. Finally, AFM28 has reached the final dose level in the escalation study providing the basis for continued development. With all three clinical programs moving forward, we are focused on the execution of these programs confident in Affimed’s ability to fulfill our overarching mission of delivering innovative therapies to cancer patients."

Program Updates

AFM24 (EGFR/CD16A tumors)
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As of January 4, clinical response update to the Phase 1/2a AFM24-102 trial in EGFR-wt NSCLC reported 4 confirmed responses, including 1 CR, 3 PRs, and 7 stable diseases in 15 heavily pre-treated patients, resulting in a disease control rate of 73 percent. All patients were pre-treated with platinum-based chemotherapy and checkpoint inhibitors PD [L]-1. Based on the promising results, Affimed expanded enrollment in this cohort to 40 patients.

In addition, the company continues to enroll in the EGFR-mut NSCLC cohort for a planned number of 25 patients.

Mature PFS data from the first 15 patients from the EGFR-wt cohort and response data from the EGFR-mut cohort are expected in Q2 2024.

Acimtamig (AFM13; CD30/CD16A tumors)

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Initial safety and efficacy data from the LuminICE-203 (AFM13-203) study expected in Q2 2024. LuminICE-203 is a Phase 2 clinical study investigating acimtamig in combination with Artiva’s AlloNK cells in patients with r/r classical Hodgkin lymphoma (HL). Safety Review Committee meeting and initiation of enrollment in cohorts 3 and 4 is expected mid-April.

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Updated Phase 1/2 AFM13-104 study data demonstrated an ORR of 97% and a CR rate of 78% in 32 patients with r/r HL, presented at ASH (Free ASH Whitepaper) 2023. As of the cutoff date, the median EFS was 9.8 months with 84% patients alive at 12 months. The median duration of response was 8.8 months. The treatment regimen continues to demonstrate a good safety and tolerability profile with no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) or graft versus host disease (GVHD) of any grade. The oral presentation included a total of 42 patients enrolled, with 36 patients treated at the recommended Phase 2 dose (RP2D). All patients were heavily pretreated and refractory to their most recent line of therapy with active progressive disease at the time of enrollment.

AFM28 (CD123/CD16A)

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Completed enrollment of the fifth cohort, recruiting patients in the sixth and final cohort in the multi-center Phase 1 open-label, dose-escalation study (AFM28-101), of AFM28 monotherapy in CD123-positive r/r AML. No dose-limiting toxicities were reported. Further clinical development of AFM28 is planned in combination with an allogeneic off-the-shelf NK cell product.

Corporate Restructuring:

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The corporate restructuring announced earlier this year has been fully implemented.

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The restructuring included a streamlining of operations resulting in a 50% reduction in the Company’s workforce.

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The Company is focusing resources on advancing its clinical programs, AFM24, acimtamig, and AFM28, through the various stages of development.

Upcoming Milestones:

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Data from the NSCLC expansion cohorts in the Phase 1/2a AFM24+atezolizumab combination study expected in Q2 2024.

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Initial data readout from the LuminICE-203 (AFM13 combination with AlloNK NK cells) study expected in Q2 2024.

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Further progress updates from AFM28-101 dose escalation expected in Q2 2024.

Full Year 2023 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 December 31, 2023, cash, cash equivalents and investments totaled €72.0 million compared to €190.3 million on December 31, 2022. Based on our current operating plan and assumptions, we anticipate that our liquidity will support operations into H2 2025.

Net cash used in operating activities for the year ended December 31, 2023, was €110.3 million compared to €104.9 million for the year ended December 31, 2022.

Total revenue for the year ended December 31, 2023, was €8.3 million compared with €41.4 million for the year ended December 31, 2022. Revenue in 2022 and 2023 predominantly relates to the Roivant and Genentech collaborations for which we have now completed the work assigned to us under the respective collaboration agreements.

Research and development expenses for the year ended December 31, 2023, were €95.0 million compared to €98.8 million in 2022.

General and administrative expenses for the year ended December 31, 2023, were €24.7 million compared to €32.1 million for the year ended December 31, 2022. The decrease was due to a decline in legal, consulting and insurance expenses, as well as share-based payment expenses.

Net finance income/costs for the year ended December 31, 2023, were €0.7 million compared to €2.1 million for the year ended December 31, 2022. Net finance income/costs are 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 year.

The weighted number of common shares outstanding for the year ended December 31, 2023, was 14.9 million, adjusted to reflect the impact of the reverse stock split executed in the first quarter of 2024.

Net loss for the year ended December 31, 2023, was €105.9 million, or €7.09 loss per common share compared with a net loss of €86.0 million, or €6.04 loss per common share, for the year ended December 31, 2022.

Additional information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2023, 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 U.S. Generally Accepted Accounting Principles. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information

Affimed will host a conference call and webcast on March 28, 2024, at 8:30 a.m. EDT / 13:30 CET to discuss full year 2023 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 View Source To access the call by phone, please use link:

https://register.vevent.com/register/BI43eadbb12f6143a5bdcb2c9549ef2e76, and you will be provided with dial-in details and a pin number.

Note: 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.