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Affimed Reports Second Quarter 2024 Financial Results & Business Update

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Affimed N.V. (Nasdaq: AFMD) reported Q2 2024 financial results and provided clinical updates. Key highlights include:

1. AFM24 combination with atezolizumab: In EGFRmut NSCLC, 23.5% ORR and 70.6% DCR observed in 17 evaluable patients.

2. Acimtamig (AFM13) combination with AlloNK®: In r/r Hodgkin Lymphoma, 83.3% ORR and 50% CRR observed in 12 patients.

3. AFM28 monotherapy: In r/r AML, 50% CR/CRi rate observed in 6 patients at 300 mg dose.

4. Financial position: €34.4 million in cash and equivalents as of June 30, 2024, with runway into H2 2025.

5. Q2 2024 financials: €0.2 million revenue, €11.7 million R&D expenses, €4.0 million G&A expenses, and €15.5 million net loss.

Affimed N.V. (Nasdaq: AFMD) ha riportato i risultati finanziari per il secondo trimestre del 2024 e fornito aggiornamenti clinici. I punti salienti includono:

1. Combinazione di AFM24 con atezolizumab: In NSCLC con mutazione EGFR, osservati 23,5% di tasso di risposta obiettiva (ORR) e 70,6% di tasso di risposta clinica (DCR) in 17 pazienti valutabili.

2. Combinazione di Acimtamig (AFM13) con AlloNK®: In linfoma di Hodgkin refrattario/recidivato, osservati 83,3% di ORR e 50% di tasso di risposta completa (CRR) in 12 pazienti.

3. Monoterapia con AFM28: In leucemia mieloide acuta refrattaria/recidivante, osservato un tasso di CR/CRi del 50% in 6 pazienti con dose di 300 mg.

4. Posizione finanziaria: €34,4 milioni in liquidità e equivalenti al 30 giugno 2024, con disponibilità fino al secondo semestre del 2025.

5. Finanziari del Q2 2024: €0,2 milioni di fatturato, €11,7 milioni di spese per ricerca e sviluppo, €4,0 milioni di spese generali e amministrative, e una perdita netta di €15,5 milioni.

Affimed N.V. (Nasdaq: AFMD) reportó los resultados financieros del segundo trimestre de 2024 y proporcionó actualizaciones clínicas. Los aspectos más destacados incluyen:

1. Combinación de AFM24 con atezolizumab: En NSCLC con mutación EGFR, se observaron un 23.5% de tasa de respuesta objetiva (ORR) y un 70.6% de tasa de respuesta clínica (DCR) en 17 pacientes evaluables.

2. Combinación de Acimtamig (AFM13) con AlloNK®: En linfoma de Hodgkin refractario/recidivante, se observaron un 83.3% de ORR y un 50% de tasa de respuesta completa (CRR) en 12 pacientes.

3. Monoterapia con AFM28: En leucemia mieloide aguda refractaria/recidivante, se observó un 50% de tasa de CR/CRi en 6 pacientes a una dosis de 300 mg.

4. Posición financiera: €34.4 millones en efectivo y equivalentes al 30 de junio de 2024, con disponibilidad hasta el segundo semestre de 2025.

5. Financieros del Q2 2024: €0.2 millones en ingresos, €11.7 millones en gastos de I+D, €4.0 millones en gastos generales y administrativos, y una pérdida neta de €15.5 millones.

Affimed N.V. (Nasdaq: AFMD)가 2024년 2분기 재무 결과를 보고하고 임상 업데이트를 제공했습니다. 주요 내용은 다음과 같습니다:

1. AFM24와 아테졸리주맙의 병용 요법: EGFR 변이가 있는 비소세포폐암(NSCLC)에서 17명의 평가 가능한 환자 중 23.5%의 객관적 반응률(ORR)과 70.6%의 임상 반응률(DCR)이 관찰되었습니다.

2. Acimtamig (AFM13)와 AlloNK®의 병용 요법: 재발/불응성 호지킨 림프종에서 12명의 환자에게서 83.3%의 ORR과 50%의 완전 반응률(CRR)이 관찰되었습니다.

3. AFM28 단독 요법: 재발/불응성 급성 골수성 백혈병(AML)에서 300mg 용량의 6명 환자에게서 50%의 CR/CRi 비율이 관찰되었습니다.

4. 재무 상황: 2024년 6월 30일 기준으로 3,440만 유로의 현금 및 현금성 자산이 있으며, 2025년 하반기까지 자금이 확보되었습니다.

5. 2024년 2분기 재무 결과: 20만 유로의 수익, 1,170만 유로의 연구개발 비용, 400만 유로의 일반 관리 비용, 그리고 1,550만 유로의 순손실이 기록되었습니다.

Affimed N.V. (Nasdaq: AFMD) a annoncé les résultats financiers du deuxième trimestre 2024 et a fourni des mises à jour cliniques. Les principaux points forts incluent :

1. Combinaison de l'AFM24 avec l'atezolizumab : Dans le NSCLC avec mutation EGFR, un taux de réponse objective (ORR) de 23,5 % et un taux de réponse clinique (DCR) de 70,6 % ont été observés chez 17 patients évaluables.

2. Combinaison de l'Acimtamig (AFM13) avec l'AlloNK® : Dans le lymphome de Hodgkin réfractaire/récidivant, un ORR de 83,3 % et un taux de réponse complète (CRR) de 50 % ont été observés chez 12 patients.

3. Monothérapie avec l'AFM28 : Dans la leucémie myéloïde aiguë réfractaire/récidivante, un taux de CR/CRi de 50 % a été observé chez 6 patients à une dose de 300 mg.

4. Situation financière : 34,4 millions d'euros de liquidités et équivalents au 30 juin 2024, avec une trésorerie suffisante jusqu'au deuxième semestre 2025.

5. Finances du T2 2024 : 0,2 million d'euros de revenus, 11,7 millions d'euros de dépenses en R&D, 4,0 millions d'euros de dépenses administratives et générales, et une perte nette de 15,5 millions d'euros.

Affimed N.V. (Nasdaq: AFMD) hat die Finanzzahlen für das zweite Quartal 2024 veröffentlicht und klinische Updates bereitgestellt. Die wichtigsten Highlights umfassen:

1. Kombination von AFM24 mit Atezolizumab: Bei EGFR-mutiertem NSCLC wurde bei 17 bewertbaren Patienten eine objektive Ansprechrate (ORR) von 23,5% und eine klinische Ansprechrate (DCR) von 70,6% beobachtet.

2. Kombination von Acimtamig (AFM13) mit AlloNK®: Bei r/r Hodgkin-Lymphom wurde bei 12 Patienten eine ORR von 83,3% und eine vollständige Ansprechrate (CRR) von 50% beobachtet.

3. Monotherapie mit AFM28: Bei r/r AML wurde eine CR/CRi-Rate von 50% bei 6 Patienten in einer Dosis von 300 mg beobachtet.

4. Finanzielle Situation: Zum 30. Juni 2024 verfügte das Unternehmen über 34,4 Millionen Euro an liquiden Mitteln und Äquivalenten, mit Finanzierungssicherheit bis in die zweite Hälfte 2025.

5. Finanzen für Q2 2024: 200.000 Euro Umsatz, 11,7 Millionen Euro F&E-Ausgaben, 4,0 Millionen Euro Verwaltungs- und Betriebskosten und 15,5 Millionen Euro Nettoverlust.

Positive
  • AFM24 combination with atezolizumab showed 23.5% ORR and 70.6% DCR in EGFRmut NSCLC patients
  • Acimtamig (AFM13) combination with AlloNK® demonstrated 83.3% ORR and 50% CRR in r/r Hodgkin Lymphoma patients
  • AFM28 monotherapy achieved 50% CR/CRi rate in r/r AML patients at 300 mg dose
  • FDA Fast Track designation received for AFM24 with atezolizumab in EGFRwt NSCLC
  • Cash runway extended into H2 2025
  • Significant reduction in net cash used in operating activities from €33.2 million in Q2 2023 to €16.5 million in Q2 2024
  • Decrease in R&D expenses from €25.3 million in Q2 2023 to €11.7 million in Q2 2024
  • Reduction in G&A expenses from €6.3 million in Q2 2023 to €4.0 million in Q2 2024
Negative
  • Revenue decreased from €1.4 million in Q2 2023 to €0.2 million in Q2 2024
  • Net loss of €15.5 million in Q2 2024, although improved from €29.4 million in Q2 2023

Insights

The clinical data for AFM24 in combination with atezolizumab shows promising results in EGFR-mutant NSCLC patients. With an 23.5% ORR and 70.6% DCR in heavily pretreated patients, this combination demonstrates significant potential in a challenging patient population. The durability of responses, with 8 out of 17 patients continuing treatment after 7 months, is particularly encouraging.

For acimtamig (AFM13) combined with AlloNK, the 83.3% ORR and 50% CRR in relapsed/refractory Hodgkin Lymphoma patients who've exhausted standard treatments is remarkable. These results suggest this combination could offer a valuable new option for patients with alternatives.

AFM28's monotherapy results in r/r AML, with a 50% CR/CRi rate at the 300 mg dose, are noteworthy and warrant further investigation. This early efficacy signal in a difficult-to-treat population is encouraging for the development of AFM28.

Affimed's financial position shows careful management of resources amid ongoing clinical development. With €34.4 million in cash and equivalents as of June 30, 2024 and a projected runway into H2 2025, the company appears to have sufficient funding for near-term operations and key clinical milestones.

The reduction in net cash used in operating activities from €33.2 million to €16.5 million year-over-year demonstrates effective cost control, primarily through lower R&D and personnel expenses. This efficiency is important for extending the cash runway.

While revenue decreased to €0.2 million from €1.4 million, the significant reduction in net loss from €29.4 million to €15.5 million is a positive indicator of improved financial health. However, ongoing clinical trials will likely require additional funding in the future, potentially through equity offerings or partnerships.

Affimed's pipeline progress demonstrates the potential of its innate cell engager platform across multiple cancer types. The company's strategy of targeting both solid tumors and hematological malignancies provides diversification and multiple shots on goal.

The FDA Fast Track designation for AFM24 with atezolizumab in EGFRwt NSCLC is a significant regulatory milestone, potentially accelerating development and review. This, combined with the promising data in EGFRmut NSCLC, positions AFM24 as a key asset.

The advancement of acimtamig (AFM13) and AFM28 in hematological cancers further validates Affimed's platform. The strong efficacy signals in heavily pretreated populations could lead to accelerated development paths. However, investors should note that while early data is promising, larger studies will be needed to confirm these results and support potential regulatory submissions.

  • AFM24 combination with atezolizumab: 24 patients treated in the EGFR mutant (EGFRmut) non-small cell lung cancer (NSCLC) cohort; in 17 response-evaluable patients: 1 complete response (CR), 3 partial responses (PRs) and 8 stable diseases (SDs) were reported. Objective response rate (ORR) is 23.5% (4/17) and disease control rate (DCR) is 70.6% (12/17). Median follow-up of > 7 months, 8 of 17 patients continue on treatment.
  • The EGFR wild type (EGFRwt) cohort of treatment refractory NSCLC patients has treated 40 patients; ORR and safety data is expected in Q4 2024
  • Acimtamig (AFM13) combination with AlloNK® (AB-101): Enrollment for relapsed/refractory (r/r) Hodgkin Lymphoma (HL) patients in cohorts 1 and 2 is completed (n=12); cohort 3 and cohort 4 recruitment on track (10/12 patients). In cohort 1 and 2, an ORR of 83.3% (10/12) and a complete response rate (CRR) of 50% (6/12) were observed.
  • AFM28 monotherapy phase 1 dose-escalation study: Of the 6 patients with relapsed/refractory Acute Myeloid Leukemia (r/r AML) treated at dose level 6 (300 mg weekly), 3 patients showed either a CR or complete response with incomplete hematological recovery (CRi). Based on the encouraging activity an additional 6 patients will be recruited at 300 mg.
  • Cash runway into H2 2025: As of June 30, 2024, cash, cash equivalents and investments were €34.4 million. Based on operating and financial plans cash-runway projected into H2 2025.

MANNHEIM, Germany, Sept. 05, 2024 (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 and provided an update on clinical and corporate progress for the quarter ended June 30, 2024.

“We continue to generate compelling data across our clinical programs," said Dr. Andreas Harstrick, Chief Medical Officer of Affimed. "In solid tumors, our combination study is making significant progress, and we are excited to see objective responses and meaningful tumor control, even in patients with EGFR mutant lung cancer — a disease often resistant to immunomodulation. It's particularly encouraging that these outcomes are achieved without chemotherapy, which is important given the intolerance many pretreated patients have for such treatments. Our programs in hematologic malignancies are also advancing well. Recent updates from the 12 patients of the LuminICE-203 study reveal remarkable efficacy, in an advanced Hodgkin lymphoma population that had exhausted all approved treatment options. Additionally, AFM28 continues to show promise as a monotherapy in AML. The data shared today underscore our strategy of leveraging the innate immune system in our fight against cancer and reinforce our commitment to advancing these clinical programs."

Pipeline Highlights:

AFM24 (EGFR / CD16A)
In the AFM24-102 trial (combination with atezolizumab):

  • 24 heavily pretreated EGFRmut NSCLC patients are in the trial; in 17 patients that are response evaluable per protocol, 1 CR, 3 PRs and 8 SDs were observed. All responses have been confirmed by follow-up scan. ORR is 23.5% (4/17) and DCR is 70.6% (12/17). Median follow-up is > 7 months and 8 out of the 17 patients continue on treatment. All 4 responders remained on treatment for at least 7 months. Final PFS data from the EGFRmut cohort is expected at a scientific conference in H1 2025.
  • All patients were pretreated with TKIs (~60% with third generation TKIs) and the majority (76%) had also received platinum-based chemotherapy.
  • The EGFRwt NSCLC cohort of patients who failed chemotherapy and PD-1/PD-L1 has continued enrollment, with 40 patients on trial. ORR and safety for this cohort is expected in Q4 2024.
  • In May, the Company received FDA Fast Track designation for the combination treatment of AFM24 with atezolizumab for EGFRwt NSCLC patients.

Acimtamig (AFM13; CD30 / CD16A)
High efficacy observed in the first 12 patients with advanced HL in cohorts 1 and 2 of the Phase 2 LuminICE-203 study showing an ORR of 83.3 % and CRR of 50%.

  • In the multi-center, multi-cohort, open-label Phase 2 LuminICE-203 trial, patients with advanced, treatment refractory Hodgkin Lymphoma receive combination of CD30-targeting innate cell engager acimtamig (AFM13) with AlloNK.
  • All HL patients were heavily pretreated with a median of 4 lines of prior therapy, having exhausted all standard of care treatment options, including combination chemotherapy, brentuximab vedotin and checkpoint inhibitors; 50% of patients had also failed prior autologous or allogeneic stem cell transplantation (SCT).
  • Enrollment in cohorts 1 and 2 (acimtamig doses of 200 mg or 300 mg; AlloNK 2x109 per week for 3 weeks) is completed: In the 12 patients, 6 CRs and 4 PRs were observed.
  • Enrollment in cohorts 3 and 4 (acimtamig 200 mg or 300 mg; 4x109 in week one and 2x109 AlloNK in weeks 2 and 3) has progressed well with 10/12 patients on study.
  • Treatment related adverse events were consistent with previous experience and side effects related to acimtamig and AlloNK were well manageable with standard of care treatment.
  • Data from the study is expected to be presented at a scientific conference in Q4 2024.

AFM28 (CD123 / CD16A)
In the sixth cohort (300 mg) of the multi-center Phase 1 open-label, dose-escalation study (AFM28-101), of AFM28 monotherapy in CD123-positive r/r AML, 3 out of 6 patients (50%) showed a CR or CRi.

  • Of 6 patients treated at dose level 6 at 300 mg, 1 patient showed a CR, 2 patients a CRi for a composite complete response rate (CRcR, defined as CR+CRi) of 50% (3/6) and 2 patients achieved SD.
  • Of 6 patients treated at dose level 5 at 250 mg, 1 patient showed a CR, lasting 6 months, a CRR of 17% (1/6) ; the other 5 patients achieved SD as best response.
  • No dose-limiting toxicities were reported in dose levels 5 and 6.
  • An additional 6 patients will be enrolled at 300 mg of AFM28.
  • Data from the study is expected to be presented at a scientific conference in Q4 2024.

Upcoming Milestones:

  • LuminICE-203: Efficacy update of cohorts 1-4 expected to be presented at a future scientific conference in Q4 2024.
  • AFM24-102: ORR and safety data from the EGFRwt cohort in Q4 2024.
  • AFM28-101: Data from the study is expected to be presented at a scientific conference in Q4 2024.
  • AMF24-102: Mature PFS data from EGFRmut and EGFRwt cohorts expected to be presented at a future conference in H1 2025.

Second Quarter 2024 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 June 30, 2024, cash, cash equivalents and short-term investments totaled €34.4 million. Based on current operating and budget assumptions, the Company expects that cash, cash equivalents and investments, together with anticipated proceeds from its ATM program and the sale of AbCheck, will finance its operations into the second half of 2025.

Net cash used in operating activities for the quarter ended June 30, 2024 was €16.5 million compared to €33.2 million for the quarter ended June 30, 2023. The decline was mainly due to lower research and development expenditure and personnel expenses due to the reduction in head count.   

Total revenue for the quarter ended June 30, 2024, was €0.2 million compared with €1.4 million for the quarter ended June 30, 2023. Revenue in 2024 only related to a platform license provided to Genentech and 2023 predominantly related to the Roivant research collaborations for which all work has been completed. 

Research and development expenses for the quarter ended June 30, 2024, were €11.7 million compared to €25.3 million in 2023. The decrease was primarily a result of lower expenses associated with the development of acimtamig and AFM24, due to a decrease in procurement of clinical trial material, clinical trial costs and manufacturing costs, decrease in head count due to the corporate restructuring.

General and administrative expenses for the quarter ended June 30, 2024, were €4.0 million compared to €6.3 million for the quarter ended June 30, 2023. The decrease was due to declines in headcount, in legal and consulting expenses, insurance expenses and share-based payment expenses. 

Net loss for the quarter ended June 30, 2024, was €15.5 million, or €1.01 loss per common share compared with a net loss of €29.4 million, or €1.97 loss per common share, for the quarter ended June 30, 2023. 

The weighted number of common shares outstanding for the quarter ended June 30, 2024, was 15,300,912 shares. 

Additional information regarding these results will be included in the notes to the consolidated financial statements as of June 30, 2024, 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 September 5, 2024, at 8:30 a.m. EDT / 14:30 CET to discuss second quarter 2024 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/BI53034c7725d043b0854377307e1cd8a3, 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.

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 innate cell engagers (ICE®) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE® are generated on the Company’s proprietary ROCK® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells.  A number of ICE® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, 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 Statement
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 acimtamig (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 macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, 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) acimtamig in combination with NK cell therapy is based on AFM13 (acimtamig) precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AlloNK® (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


Affimed N.V.      
Unaudited consolidated interim statements of comprehensive loss 
(in € thousand)      
     
  For the three months ended June 30 For the six months ended June 30
  2024 2023  2024 2023 
Revenue 154 1,390  309 5,900 
       
Other income - net 56 717  233 1,127 
Research and development expenses (11,727)(25,273) (27,118)(54,804)
General and administrative expenses (4,036)(6,276) (8,512)(13,126)
       
Operating loss (15,553)(29,442) (35,088)(60,903)
       
Finance income / (costs) - net 105 47  465 (472)
       
Loss before tax (15,448)(29,395) (34,623)(61,375)
       
Income taxes (3)0  (3)(3)
       
Loss for the period (15,451)(29,395) (34,626)(61,378)
       
       
Total comprehensive loss (15,451)(29,395) (34,626)(61,378)
       
Basic and diluted loss per share in € per share (undiluted = diluted) (1.01)(1.97) (2.28)(4.11)
Weighted number of common shares outstanding 15,300,912 14,933,934  15,212,555 14,933,934 
       


Affimed N.V.    
Consolidated interim statements of financial position    
(in € thousand)    
  June 30, 2024 (unaudited) December 31, 2023
ASSETS    
Non-current assets    
Intangible assets 18  25 
Leasehold improvements and equipment 2,331  4,905 
Right-of-use assets 5,638  8,039 
  7,987  12,969 
Current assets    
Cash and cash equivalents 10,764  38,529 
Investments 23,683  33,518 
Other financial assets 878  851 
Trade and other receivables 5,717  5,327 
Inventories 0  463 
Other assets and prepaid expenses4,145  5,500 
  45,187  84,188 
     
TOTAL ASSETS 53,174  97,157 
     
EQUITY AND LIABILITIES    
Equity    
Issued capital 1,568  1,500 
Capital reserves 599,131  593,666 
Fair value reserves (1,231) (1,231)
Accumulated deficit (570,754) (536,128)
Total equity  28,714  57,807 
     
Non current liabilities    
Borrowings3,603  6,319 
Contract liabilities 155  464 
Lease liabilities 4,030  6,660 
Total non-current liabilities 7,788  13,443 
     
Current liabilities    
Trade and other payables 9,171  18,916 
Borrowings5,833  5,833 
Lease liabilities 1,049  539 
Contract liabilities619  619 
Total current liabilities 16,672  25,907 
     
TOTAL EQUITY AND LIABILITIES 53,174  97,157 
     


Affimed N.V.    
Unaudited consolidated interim statements of cash flows    
(in € thousand) 
  For the six months ended June 30
  2024 2023
Cash flow from operating activities    
Loss for the period (34,626) (61,378)
Adjustments for the period:    
- Income taxes 3  3 
- Depreciation and amortization 2,520  577 
- Net gain on disposal of leasehold improvements and equipment (24) 0 
- Loss from write-down of inventories 456  0 
- Share-based payments 1,472  7,389 
- Finance income / (costs) - net (465) 472 
  (30,664) (52,937)
Change in trade and other receivables (391) 543 
Change in inventories 7  (66)
Change in other assets and prepaid expenses 1,525  (5,473)
Change in trade, other payables, provisions and contract liabilities (10,308) (8,867)
  (39,831) (66,800)
Interest received 155  924 
Paid interest (648) (695)
Paid income tax (3) (3)
Net cash used in operating activities (40,327) (66,574)
     
Cash flow from investing activities    
Purchase of leasehold improvements and equipment, including upfront payments for right-of-use assets (20) (11)
Cash received from the sale of financial assets 10,857  0 
Cash received from the sale of leasehold improvements and equipment 768  0 
Net cash generated / (used) for investing activities 11,605  (11)
     
Cash flow from financing activities    
Proceeds from issue of common shares, including exercise of share-based payment awards 4,256  0 
Transaction costs related to issue of common shares (112) 0 
Repayment of lease liabilities (413) (249)
Repayment of borrowings (2,917) (2,965)
Net cash generated / (used) for financing activities 814  (3,214)
     
Exchange-rate related changes of cash and cash equivalents 143  (431)
Net changes to cash and cash equivalents (27,908) (69,799)
Cash and cash equivalents at the beginning of the period 38,529  190,286 
Cash and cash equivalents at the end of the period 10,764  120,056 
     


Affimed N.V.          
Unaudited consolidated interim statements of changes in equity for the year    
(in € thousand)          
  Issued capital Capital reserves Fair Value reserves Accumulated deficit Total equity
           
Balance as of January 1, 2023 1,493 582,843 (1,231) (430,190) 152,915 
           
Equity-settled share-based payment awards   7,389     7,389 
Loss for the period       (61,378) (61,378)
           
Balance as of June 30, 2023 1,493 590,232 (1,231) (491,568) 98,926 
           
Balance as of January 1, 2024 1,500 593,666 (1,231) (536,128) 57,807 
           
Issue of common shares 68 3,993     4,061 
Equity-settled share-based payment awards   1,472     1,472 
Loss for the period       (34,626) (34,626)
           
Balance as of June 30, 2024 1,568 599,131 (1,231) (570,754) 28,714 
           

FAQ

What were Affimed's (AFMD) key clinical results in Q2 2024?

Affimed reported positive results for AFM24 in NSCLC (23.5% ORR, 70.6% DCR), Acimtamig in Hodgkin Lymphoma (83.3% ORR, 50% CRR), and AFM28 in AML (50% CR/CRi rate at 300 mg dose).

How much cash does Affimed (AFMD) have as of June 30, 2024?

Affimed reported €34.4 million in cash, cash equivalents, and investments as of June 30, 2024.

What is Affimed's (AFMD) cash runway projection?

Based on current plans, Affimed projects its cash runway to extend into the second half of 2025.

What was Affimed's (AFMD) net loss for Q2 2024?

Affimed reported a net loss of €15.5 million for the quarter ended June 30, 2024.

Did Affimed (AFMD) receive any FDA designations in Q2 2024?

Yes, Affimed received FDA Fast Track designation for the combination treatment of AFM24 with atezolizumab for EGFRwt NSCLC patients in May 2024.

Affimed N.V.

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Biotechnology
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United States of America
Mannheim