Affimed Stock Price, News & Analysis

Affimed N.V. (AFMD), a clinical-stage immuno-oncology company, has announced filing for insolvency proceedings with the local court of Mannheim, Germany. Despite ongoing fundraising efforts, the company failed to secure sufficient capital to continue operations of Affimed N.V. and its subsidiaries Affimed GmbH and Affimed Inc.

The management has determined that both Affimed N.V. and Affimed GmbH are overindebted (Überschuldung), necessitating insolvency filing under German law. As a result of these proceedings, Affimed's common shares will be suspended from trading and subsequently delisted from The Nasdaq Global Market. The company's current liquidity condition raises substantial doubt about its ability to continue as a going concern.

Affimed presented promising results for its cancer drug AFM24 in treating non-small cell lung cancer (NSCLC) at the 2025 AACR Annual Meeting. The study analyzed 72 NSCLC patients, revealing significantly better outcomes in patients with higher drug exposure.

Key findings show patients with above-median drug exposure achieved:

• 33.3% objective response rate vs 5.6% in low-exposure group
• 7.3 months progression-free survival vs 2.9 months
• 83.3% disease control rate vs 58.3%

Based on these results, Affimed will optimize future trials using a higher 720mg weekly dose, which achieves target exposure levels by week two of treatment. Importantly, higher exposure showed no increased safety concerns. The combination therapy with atezolizumab showed consistent benefits, with 37.04% response rate in high-exposure patients versus 7.14% in low-exposure groups.

Affimed N.V. (Nasdaq: AFMD) has announced the acceptance of three abstracts for presentation at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago. The presentations include:

1. An oral presentation on the phase 2 LuminICE-203 study of acimtamig in combination with AlloNK® (AB-101) for relapsed or refractory classical Hodgkin lymphoma, scheduled for May 30.

2. Two poster presentations on AFM24 in combination with atezolizumab for non-small cell lung cancer (NSCLC): one focusing on EGFR-expressing NSCLC without driver mutations, and another on NSCLC with EGFR kinase domain mutations. Both posters will be presented on June 2.

The full abstracts will be published online on May 22, 2025.

Affimed N.V. (AFMD) has received a deficiency notice from Nasdaq dated April 15, 2025, due to its stock price closing below the minimum requirement of $1.00 per share for the last 30 consecutive business days. The company has been granted an initial 180-day period until October 13, 2025, to regain compliance with the minimum bid price requirement.

If compliance is not achieved during this period, Affimed may consider transferring from The Nasdaq Global Select Market to The Nasdaq Capital Market, which could provide an additional 180 days (until April 13, 2025) to meet requirements. This transfer would be subject to meeting other listing criteria. The notice does not immediately affect the listing or trading of Affimed's shares.

Affimed N.V. (Nasdaq: AFMD) has announced that their abstract focusing on AFM24 dose optimization has been accepted for poster presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting in Chicago (April 25-30, 2025).

The presentation will detail dose optimization using exposure response analysis for AFM24, both as monotherapy and in combination with atezolizumab, in patients with advanced/metastatic non-small cell lung cancer. The poster presentation is scheduled for Tuesday, April 29, 2025, from 9:00 AM to 12:00 PM CDT in Poster Section 49.

Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company, has announced its participation in the upcoming Leerink Partners Global Healthcare Conference 2025. The company's CEO, Dr. Shawn Leland, will engage in a fireside chat on Tuesday, March 11, 2025, at 2:20 p.m. EDT.

Investors and interested parties can access a live webcast of the presentation through Affimed's website investor section. The presentation recording will remain available for 30 days following the event. For those interested in one-on-one meetings with Affimed's management team, arrangements can be made through Leerink Partners representatives or by contacting Alex Fudukidis.

Affimed (AFMD) reported positive clinical data from the AFM24-102 trial combining AFM24 with atezolizumab in non-small cell lung cancer (NSCLC) patients. In 33 EGFR wild-type patients, the combination showed a 21% overall response rate and 76% disease control rate, with tumor shrinkage in 48% of patients. The median progression-free survival was 5.6 months.

In 17 EGFR mutant patients, results showed a 24% overall response rate and 71% disease control rate, with tumor shrinkage in 41% of patients. Both patient groups demonstrated manageable side effects. A post-hoc analysis revealed that patients with higher AFM24 exposure had significantly better outcomes, leading to plans for using a higher 720mg weekly dose in future development.

Affimed announced promising Phase 1 data for AFM28 in treating relapsed/refractory Acute Myeloid Leukemia (R/R AML). The study, involving 29 heavily pretreated patients, demonstrated a 40% composite complete remission rate at the highest dose level (300 mg). Key findings include:

- Well-managed safety profile with mainly Grade 1 and 2 infusion-related reactions in 45% of patients
- No neurotoxicity or immune-related side effects
- One complete remission at 250 mg dose level with 6.5-month treatment duration
- At 300 mg dose level, achieved 1 CR and 3 CRi in 10 evaluable patients

The study included patients with a median of two prior treatment lines, with 86% having adverse risk profiles. Based on these results, evaluation of higher dose levels is planned.

Affimed N.V. (Nasdaq: AFMD) announced it will host a conference call on Tuesday, December 17, at 8:30 a.m. EST / 14:30 CET to review clinical data from AFM24-102, a combination trial of its AFM24 innate cell engager ICE® with atezolizumab in non-small cell lung cancer. The call will be accessible via phone and webcast through the company's website, with dial-in details provided upon registration. A replay will be available for 30 days following the call.