AFMD Affimed N.V.

6.39
0  0%
Previous Close 6.39
Open 6.41
52 Week Low 3.085
52 Week High 11.74
Market Cap $765,086,937
Shares 119,731,915
Float 116,414,009
Enterprise Value $506,324,313
Volume 250,212
Av. Daily Volume 1,019,065
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Upcoming Catalysts

Drug Stage Catalyst Date
AFM13 + NK cells (AFM13-104)
CD30-positive lymphomas
Phase 1
Phase 1
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AFM24-101
EGFR-expressing solid tumors
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
AFM24-103/SNK-01
EGFR-expressing tumors, Non-small cell lung cancer, and Squamous cell carcinoma of the head and neck
Phase 1/2
Phase 1/2
Phase 1/2 trial planned for 2H 2021.
AFM24-102 and TECENTRIQ (atezolizumab)
EGFR Expressing Solid Tumors, Non-small cell lung cancer, and Gastric/gastroesophageal junction (GEJ) cancer
Phase 1/2
Phase 1/2
Phase 1/2 trial planned for 2H 2021.
AFM13 (REDIRECT)
CD30-positive peripheral T cell lymphoma (PTCL)
Phase 2
Phase 2
Phase 2 enrollment to be completed 1H 2022.
AFM13 with KEYTRUDA (pembrolizumab)
Hodgkin Lymphoma - Cancer
Phase 1b
Phase 1b
Phase 1b updated data at ICML June 22, 2019 noted ORR of 88% at highest dose, CR rates of 42%-46%.
AFM13
T-Cell, Cutaneous Lymphoma
Phase 1/2
Phase 1/2
Phase 1/2 data presented at ASH 2020. Objective Response Rate (ORR) of 42%(6/14).

Latest News

    • AFM13 monotherapy: Enrollment is on track and expected to be completed in the first half of 2022.
    • AFM13 combination with NK cells: All three dose escalation cohorts are fully enrolled with no dose limiting toxicities observed; additional patients are being enrolled at the highest dose level to confirm safety and generate additional efficacy data; data update expected at a scientific conference in Q4 2021.
    • AFM24 monotherapy: Based on current data, doses used in cohorts 5 (320 mg) and 6 (480 mg) are pharmacologically active; no classic EGFR related side effects observed to date; dose expansion phase expected to start in 2021.
    • AFM24 combination with anti PD-L1 checkpoint inhibitor: Clinical trial of AFM24 with atezolizumab (Tecentriq®) on track to…
    • AFM13 monotherapy: Enrollment is on track and expected to be completed in the first half of 2022.
    • AFM13 combination with NK cells: All three dose escalation cohorts are fully enrolled with no dose limiting toxicities observed; additional patients are being enrolled at the highest dose level to confirm safety and generate additional efficacy data; data update expected at a scientific conference in Q4 2021.
    • AFM24 monotherapy: Based on current data, doses used in cohorts 5 (320 mg) and 6 (480 mg) are pharmacologically active; no classic EGFR related side effects observed to date; dose expansion phase expected to start in 2021.
    • AFM24 combination with anti PD-L1 checkpoint inhibitor: Clinical trial of AFM24 with atezolizumab (Tecentriq®) on track to start in 2021.
    • AFM24 combination with NK cells: Clinical trial of AFM24 with NKGen Biotech's SNK01 NK autologous cell therapy on track to start in 2021.
    • Cash and cash equivalents as of June 30, 2021, were approximately €222.7 million with anticipated cash runway into the second half of 2023.
    • Conference call and webcast scheduled for September 8, 2021, at 8:30 a.m. EDT.

    HEIDELBERG, Germany, Sept. 08, 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 June 30, 2021, and provided an update on clinical and corporate progress.

    "We are pleased with the continued progress in our development of AFM13, AFM24 and AFM28," said Adi Hoess, CEO of Affimed. "By the end of this year, we expect to report additional data from AFM13-104, progress our parallel development strategy for AFM24 and disclose the details of our AFM28 program. We expect our broad development pipeline will generate an ongoing stream of data over the next several quarters," 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; the trial combined the high- and low-CD30 expressing cohorts 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 as monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL).
    • Affimed reported that all three dose escalation cohorts in the investigator sponsored trial (IST) at The University of Texas MD Anderson Cancer Center of AFM13 precomplexed with cord blood-derived natural killer (NK) cells (AFM13-104) are now fully enrolled and patients have completed at least the first cycle of therapy without dose limiting toxicities. Additional patients are being enrolled at the highest dose level to generate additional data on safety and efficacy. The study is evaluating increasing doses of cord-blood derived NK cells precomplexed with AFM13 followed by three weekly infusions of AFM13 monotherapy in patients with recurrent or refractory CD30-positive lymphomas. As presented at AACR in April 2021, the first four patients showed a 100% objective response rate with two out of four patients having a complete response (50%).

    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. Affimed announced that it has identified pharmacologically active doses in its monotherapy dose escalation study and will initiate its three-pronged development strategy in parallel across a broad set of solid tumor indications. The three studies are expected to generate a continuous flow of data.
    • In AFM24-101, the monotherapy phase 1/2a clinical trial of AFM24, Affimed increased the size of cohort 5 (320 mg) and cohort 6 (480 mg) to generate additional pharmacokinetic and pharmacodynamic data that is expected to aid the selection of the recommended phase 2 dose. To date, no classic EGFR related side effects have been observed. Affimed expects to determine the recommended phase 2 dose and start the dose expansion phase of the trial in 2021. The indications will be as follows:
      • 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
    • 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 second half 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 on track to start in 2021. 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, failing standard of care therapy

    Preclinical Programs

    • Affimed expects to disclose the target of its preclinical asset, AFM28, and publish initial preclinical data in Q4 2021. The company remains on track to file an IND application for AFM28 in the first half of 2022.

    Second Quarter 2021 Financial Highlights

    (Figures for the quarters ended June 30, 2021, and 2020 are unaudited.)

    As of June 30, 2021, cash and cash equivalents totaled €222.7 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 June 30, 2021 was €17.3 million compared to €15.0 million for the quarter ended June 30, 2020.

    Total revenue for the quarter ended June 30, 2021, was €9.7 million compared with €2.9 million for the quarter ended June 30, 2020. Revenue predominately relates to the Genentech and Roivant collaborations.

    Research and development expenses for the quarter ended June 30, 2021 amounted to €21.8 million compared to €11.7 million for the quarter ended June 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 increased 108.7% from €2.6 million in the quarter ended June 30, 2020, to €5.4 million in the quarter ended June 30, 2021. The increase relates largely to higher personnel expenses due to an increase in headcount, higher premiums for our Directors and Officers liability insurance and higher legal and consulting expenses.

    Net finance costs for the quarter ended June 30, 2021 increased by 63% from €1.0 million in the quarter ended June 30, 2020, to €1.6 million. This increase is largely due to foreign exchange 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 June 30, 2021 was €18.8 million, or €0.16 per common share compared with a net loss of €12.2 million, or €0.16 per common share, for the quarter ended June 30, 2020.

    The weighted number of common shares outstanding for the quarter ended June 30, 2021 was 119.6 million.

    Additional information regarding these results will be included in the notes to the consolidated financial statements as of June 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, September 8, 2021, at 8:30 a.m. EDT to discuss second 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 6156773 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, 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.

    CONDENSED INTERIM CONSOLIDATED FINANCIAL STATEMENTS

    Unaudited interim consolidated statements of comprehensive income / (loss)

    (in € thousand)

     

      For the three months

    ended June 30
    For the six months

    ended June 30
     
      2021 202020212020 
            
    Revenue 9,707 2,93421,3668,069 
            
    Other income – net 332 8547928 
    Research and development expenses (21,800) (11,697)(33,205)(23,146) 
    General and administrative expenses (5,439) (2,606)(9,925)(6,131) 
            
    Operating loss (17,200) (11,284)(21,285)(21,180) 
            
    Finance income / (costs) – net (1,552) (954)3,947653 
            
    Loss before tax (18,752) (12,238)(17,338)(20,527) 
            
    Income taxes 0 0(2)0 
            
    Loss for the period (18,752) (12,238)(17,340)(20,527) 
    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








    (4,097) (71)(5,349)10 
            
    Other comprehensive income / (loss) (4,097) (71)(5,349)10 
            
    Total comprehensive income / (loss) (22,849) (12,309)(22,689)(20,517) 
      
            
    Earnings / (loss) per share in € per share (undiluted = diluted) (0.16) (0.16)(0.15)(0.26) 
    Weighted number of common shares outstanding 119,645,207 79,189,686117,924,83177,719,793 



    Unaudited interim consolidated statements of financial position   
    (in € thousand)   
     June 30, 2021

      December 31, 2020  
     (unaudited)

        
    ASSETS    
    Non-current assets    
    Intangible assets1,661  1,718  
    Leasehold improvements and equipment3,447  2,226  
    Long term financial assets14,693  20,042  
    Right-of-use assets1,036  940  
     20,837  24,926  
    Current assets    
    Cash and cash equivalents222,676  146,854  
    Trade and other receivables3,763  2,439  
    Inventories612  246  
    Other assets135  1,260  
     227,186  150,799  
         
    TOTAL ASSETS248,023  175,725  
         
    EQUITY AND LIABILITIES    
    Equity    
    Issued capital1,197  983  
    Capital reserves446,525  345,164  
    Fair value reserves(3,629) 1,720  
    Accumulated deficit(293,214) (275,874) 
    Total equity 150,879  71,993  
         
    Non current liabilities    
    Borrowings10,025  231  
    Contract liabilities19,361  35,992  
    Lease liabilities601  482  
    Total non-current liabilities29,987  36,705  
         
    Current liabilities    
    Trade and other payables15,838  11,394  
    Borrowings93  92  
    Lease liabilities523  492  
    Contract liabilities50,703  55,049  
    Total current liabilities67,157  67,027  
         
    TOTAL EQUITY AND LIABILITIES248,023  175,725  



    Unaudited interim consolidated statements of cash flows     
    (in € thousand)For the six months ended June 30



     
     2021  2020  
    Cash flow from operating activities    
    Income / (loss) for the period(17,340) (20,527) 
    Adjustments for the period:    
    - Income taxes2  0  
    - Depreciation and amortisation624  551  
    - Share based payments4,695  1,410  
    - Finance income / costs – net(3,947) (653) 
     (15,966) (19,219) 
    Change in trade and other receivables(1,324) (649) 
    Change in inventories(366) (125) 
    Change in other assets924  0  
    Change in trade, other payables, provisions and contract liabilities(16,262) (11,757) 
    Cash used in operating activities(32,994) (31,750) 
    Interest received0  276  
    Paid interest(377) (64) 
    Paid income tax(2) 0  
    Net cash used in operating activities(33,373) (31,538) 
         
    Cash flow from investing activities    
    Purchase of intangible assets(5) (2) 
    Purchase of leasehold improvements and equipment(1,502) (174) 
    Cash paid for investments in financial assets0  (8,101) 
    Cash received from maturity of financial assets0  9,088  
    Net cash used for investing activities(1,507) 811  
         
    Cash flow from financing activities    
    Proceeds from issue of common shares, including exercise of share based payment awards103,242  21,785  
    Transaction costs related to issue of common shares(6,447) (754) 
    Proceeds from borrowings10,000  0  
    Transaction costs related to borrowings(236) 0  
    Repayment of lease liabilities(228) (257) 
    Repayment of borrowings(46) (1,128) 
    Cash flow from financing activities106,285  19,646  
         
    Exchange-rate related changes of cash and cash equivalents4,417  431  
    Net changes to cash and cash equivalents71,405  (11,081) 
    Cash and cash equivalents at the beginning of the period146,854  95,234  
    Cash and cash equivalents at the end of the period222,676  84,584  



    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, 2020762 270,451 1,962  (234,508) 38,667 




    Issue of common shares




    83
     20,859     20,942 
    Equity-settled share based payment awards  1,410     1,410 
    Loss for the period      (20,527) (20,527)
    Other comprehensive income    10    10 
    Balance as of June 30, 2020845 292,720 1,972  (255,035) 40,502 




    Balance as of January 1, 2021
    983 345,164 



               1,720

      (275,874) 71,993 
              
    Issue of common shares205 94,135     94,340 
    Exercise of share based payment awards9 2,531     2,540 
    Equity-settled share based payment awards  4,695     4,695 
    Loss for the period      (17,340) (17,340)
    Other comprehensive income / (loss)    (5,349)   (5,349)
              
    Balance as of June 30, 20211,197 446,525 (3,629) (293,214) 150,879 


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  1. HEIDELBERG, Germany, Aug. 26, 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 announced that management will present and host one-on-one meetings at the following investor conferences during the month of September 2021.

    Citi's 16th Annual BioPharma Virtual Conference (September 8-10, 2021)
    Date: Wednesday, September 8, 2021
    No presentation, only one-on-one meetings
    Location: Virtual

    2021 Wells Fargo Virtual Healthcare Conference (September 9-10, 2021)
    Date: Thursday, September 9, 2021
    Presentation Time: 8:00 a.m. Eastern Time
    Webcast: https://www.affimed.com/investors/webcasts_cp/
    Location: Virtual

    Morgan Stanley 19th Annual

    HEIDELBERG, Germany, Aug. 26, 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 announced that management will present and host one-on-one meetings at the following investor conferences during the month of September 2021.

    Citi's 16th Annual BioPharma Virtual Conference (September 8-10, 2021)

    Date: Wednesday, September 8, 2021

    No presentation, only one-on-one meetings

    Location: Virtual

    2021 Wells Fargo Virtual Healthcare Conference (September 9-10, 2021)

    Date: Thursday, September 9, 2021

    Presentation Time: 8:00 a.m. Eastern Time

    Webcast: https://www.affimed.com/investors/webcasts_cp/

    Location: Virtual

    Morgan Stanley 19th Annual Global Healthcare Conference (September 9-15, 2021)

    Date: Friday, September 10, 2021

    No Presentation, only one-on-one meetings

    Location: Virtual

    Cantor Fitzgerald Virtual Global Healthcare Conference 2021 (September 27-30, 2021)

    Date: Monday, September 27, 2021

    Presentation Time: 10:00 a.m. Eastern Time

    Webcast: https://www.affimed.com/investors/webcasts_cp/

    Location: Virtual

    For more information or to schedule a one-on-one meeting with Affimed's management, please contact your conference representative or Alex Fudukidis via email at a.fudukidis@affimed.com or phone at +1 (917) 436-8102.

    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, 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



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  2. HEIDELBERG, Germany, Aug. 23, 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 announced that it will release second quarter 2021 results on Wednesday, September 8, 2021, and host a conference call at 8:30 a.m. EDT to discuss 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 6156773 approximately 15 minutes prior to the call. To access the live audio webcast of the conference call please visit the "Investors" section…

    HEIDELBERG, Germany, Aug. 23, 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 announced that it will release second quarter 2021 results on Wednesday, September 8, 2021, and host a conference call at 8:30 a.m. EDT to discuss 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 6156773 approximately 15 minutes prior to the call. To access the live audio webcast of the conference call please visit the "Investors" section of company's website at https://www.affimed.com/investors/webcasts_cp/. A replay of the call will be archived on the Affimed website for 30 days after 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.

    Investor Relations Contact

    Alexander Fudukidis

    Director, Head of Investor Relations

    E-Mail: a.fudukidis@affimed.com

    Tel.: +1 (917) 436-8102



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    • AFM24 is an innate cell engager with a novel and distinctive mechanism of action, designed to address the need of broader patient populations than current EGFR-targeting treatments.
    • Preclinical data demonstrate AFM24's activation of the innate immune system, acting independently of EGFR-expression levels, EGFR-pathway mutations and downstream signal transduction.
    • A toxicity study in cynomolgus monkeys shows AFM24 was well tolerated up to the highest dose level (75 mg/kg) with no skin or organ toxicity observed.
    • The published data supported the Investigational New Drug application for the ongoing AFM24 Phase 1/2a dose escalation study.

    HEIDELBERG, Germany, July 30, 2021 (GLOBE NEWSWIRE) -- Affimed N.V. (NASDAQ:AFMD), a clinical-stage immuno-oncology…

    • AFM24 is an innate cell engager with a novel and distinctive mechanism of action, designed to address the need of broader patient populations than current EGFR-targeting treatments.

    • Preclinical data demonstrate AFM24's activation of the innate immune system, acting independently of EGFR-expression levels, EGFR-pathway mutations and downstream signal transduction.
    • A toxicity study in cynomolgus monkeys shows AFM24 was well tolerated up to the highest dose level (75 mg/kg) with no skin or organ toxicity observed.
    • The published data supported the Investigational New Drug application for the ongoing AFM24 Phase 1/2a dose escalation study.

    HEIDELBERG, Germany, July 30, 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, announced today the publication of a comprehensive preclinical in vitro and in vivo data package of its innate cell engager (ICE®) AFM24 (CD16A/EGFR) in mAbs. The published data were the basis for the Investigational New Drug (IND) clearance for Affimed's ongoing Phase 1/2a study with AFM24 monotherapy in patients with EGFR expressing solid tumors. The preclinical data demonstrates AFM24's unique mechanism of action that harnesses the innate immune system to induce tumor cell killing via antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cell phagocytosis (ADCP).

    "These pre-clinical data are encouraging as they demonstrate the potential for AFM24 to effectively target a broad set of tumors expressing varying levels of EGFR, regardless of their mutational status, and with the potential for less pronounced EGFR-related toxicities than current treatment options," said Arndt Schottelius, M.D., Ph.D., Chief Scientific Officer at Affimed. "This could be highly relevant for many patients with different tumor types despite existing EFGR-targeting therapies as these have limitations in efficacy and safety."    

    Highlights of the recently published results include:

    • AFM24 binds with high affinity to CD16A on NK cells and macrophages in vitro.
    • AFM24 potently induces ADCC via NK cells, and ADCP via macrophages in vitro.
    • AFM24 is effective against many EGFR-positive tumor cells, regardless of EGFR expression level and KRAS/BRAF mutational status within in vitro studies.
    • AFM24 is well tolerated up to the highest dose level (75 mg/kg) with no skin and other toxicities in cynomolgus monkeys.

    The full manuscript is available here: https://bit.ly/3zLDq3i

    About AFM24

    AFM24 is a tetravalent, bispecific innate cell engager (ICE®) that activates the innate immune system by binding to CD16A on innate immune cells and EGFR, a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed's fit-for-purpose ROCK® platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.

    Affimed is evaluating AFM24 as a monotherapy for patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24-101 is a first-in-human Phase 1/2a open-label, non-randomized, multi-center, multiple ascending dose escalation and expansion study and can be found at www.clinicaltrials.gov using the identifier NCT04259450. In addition, Affimed is planning to initiate further studies evaluating AFM24 in combination with Roche's atezolizumab, an anti-PD-L1 checkpoint inhibitor and, separately, an investigation of AFM24 in combination with NKGen Biotech's autologous NK cell product.

    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, 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.

    Affimed Investor Contact

    Alexander Fudukidis

    Director, Investor Relations

    E-Mail: A.Fudukidis@affimed.com

    Tel.: +1 (917) 436-8102

    Media Contact

    Mary Beth Sandin

    Vice President, Marketing and Communications

    E-Mail: M.Sandin@affimed.com

    Tel: +1 (484) 888-8195



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    • AFM13 monotherapy: Reported positive outcome from the preplanned interim analysis for the registration-directed trial in PTCL; enrollment expected to be completed in the first half of 2022.
    • AFM13 combination with NK cells: Announced 100% objective response rate in the first four response evaluable patients, including two complete responses. All three dose escalation cohorts are now fully enrolled; data update expected in the second half of 2021.
    • AFM13 preclinical data: AFM13 in combination with natural killer (NK) cells demonstrated improved tumor recognition and enhanced tumor cell killing in vitro and in vivo.
    • AFM24 monotherapy: AFM24 (phase 1/2a study) completed cohort 5 and is enrolling and treating patients in cohort 6; expansion cohorts expected…
    • AFM13 monotherapy: Reported positive outcome from the preplanned interim analysis for the registration-directed trial in PTCL; enrollment expected to be completed in the first half of 2022.
    • AFM13 combination with NK cells: Announced 100% objective response rate in the first four response evaluable patients, including two complete responses. All three dose escalation cohorts are now fully enrolled; data update expected in the second half of 2021.
    • AFM13 preclinical data: AFM13 in combination with natural killer (NK) cells demonstrated improved tumor recognition and enhanced tumor cell killing in vitro and in vivo.
    • AFM24 monotherapy: AFM24 (phase 1/2a study) completed cohort 5 and is enrolling and treating patients in cohort 6; expansion cohorts expected to start in the second half of 2021.
    • AFM24 combination with NK cells: Combination therapy clinical trial of AFM24 with NKGen Biotech's SNK01 NK autologous cell therapy on track to start in the second half of 2021.
    • AFM24 combination with anti PD-L1 checkpoint inhibitor: Combination therapy clinical trial of AFM24 with atezolizumab (Tecentriq®) on track to start in the second half of 2021.
    • Cash and cash equivalents as of March 31, 2021, were approximately €240.7 million with anticipated cash runway into the second half of 2023.
    • Conference call and webcast scheduled for July 1, 2021, at 8:30 a.m. EDT.

    HEIDELBERG, Germany, July 01, 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 March 31, 2021, and provided an update on clinical and corporate progress.

    "As we continue to build momentum with our clinical programs, we see growing interest in the important work that we are doing in the emerging field of innate immuno-oncology. We published clinical data for AFM13 that is supporting our three-pronged development strategy of our ICE® as monotherapy, in combination with NK cells and in combination with a checkpoint inhibitor," said Dr. Adi Hoess, CEO of Affimed. "Over the next several months, we have a number of value-creating events on AFM13, AFM24, where we expect to initiate several clinical studies, and AFM28, and are allocating capital across our portfolio to develop multiple opportunities for shareholder value creation."

    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; the trial combined the high- and low-CD30 expressing cohorts 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 as monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL).
    • Affimed reported all three dose escalation cohorts in the investigator sponsored trial (IST) at The University of Texas MD Anderson Cancer Center of AFM13 precomplexed with natural killer (NK) cells (AFM13-104) are now fully enrolled. The study is evaluating increasing doses of cord-blood derived NK cells pre-complexed with AFM13 followed by three weekly infusions of AFM13 monotherapy in patients with recurrent or refractory CD30-positive lymphomas.
    • Preclinical data published in Clinical Cancer Research support the therapeutic potential of AFM13, demonstrating that AFM13 in combination with NK cells improved tumor recognition and enhanced tumor cell killing in vitro and in vivo compared to NK cells alone. This data supported the Investigational New Drug (IND) application for the ongoing phase 1 clinical study of AFM13 pre-complexed with NK cells.

    AFM24 (EGFR/CD16A)

    • AFM24-101, the phase 1/2a clinical trial of AFM24, the EGFR/CD16A targeted ICE® for patients with EGFR-expressing solid tumors, completed dose cohort 5 (320 mg) and patients are currently being enrolled and treated in dose cohort 6 (480 mg). Affimed expects to determine the recommended phase 2 dose and initiate dose expansion cohorts in the second half of 2021.
    • 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 with EGFR-expressing solid tumors is on track to start in the second half of 2021.
    • The phase 1/2a combination study of AFM24 with the PD-L1 checkpoint inhibitor atezolizumab (Tecentriq®) with EGFR-expressing solid tumors is on track to start in the second half of 2021.

    Preclinical and Partnered Programs

    • Affimed expects to disclose the target of its preclinical asset AFM28 and publish initial preclinical data in the second half of 2021. The company remains on track to file an IND application for AFM28 in the first half of 2022.
    • Genentech has completed the dose escalation portion of the phase 1 study of RO7297089 (anti-BCMA/CD16A). No dose limiting toxicities were observed during the study. However, due to broader portfolio considerations, Genentech decided to stop the phase 1 study of RO7297089. The decision does not impact the development of other targets pursuant to the collaboration agreement with Genentech.

    First Quarter 2021 Financial Highlights

    (Figures for the quarter ended March 31, 2021, and 2020 are unaudited.)

    As of March 31, 2021, cash and cash equivalents totaled €240.7 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 March 31, 2021, was €16.0 million compared to €16.5 million for the quarter ended March 31, 2020.

    Total revenue for the quarter ended March 31, 2021, was €11.7 million compared with €5.1 million for the quarter ended March 31, 2020. Revenue predominately relates to the Genentech and Roivant collaborations.

    Research and development expenses for the quarter ended March 31, 2021, remained flat at €11.4 million compared to the quarter ended March 31, 2020.

    General and administrative expenses increased 27.3% from €3.5 million in the quarter ended March 31, 2020, to €4.5 million in the quarter ended March 31, 2021. The increase relates largely to higher personnel expenses, higher premiums for our Directors and Officers liability insurance and higher legal and consulting expenses.

    Net finance income for the quarter ended March 31, 2021, increased by 242% from €1.6 million in the quarter ended March 31, 2020, to €5.5 million. This increase is largely due to foreign exchange gains related to assets denominated in U.S. dollars as a result of the strengthening of the U.S. dollar against the Euro during the quarter.

    Net income for the quarter ended March 31, 2021, was €1.4 million, or €0.01 per common share compared with a net loss of €8.3 million, or loss €0.11 per common share, for the quarter ended March 31, 2020.

    The weighted number of common shares outstanding for the quarter ended March 31, 2021, was 116.2 million.

    Additional information regarding these results will be included in the notes to the consolidated financial statements as of March 31, 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, July 1, 2021, at 8:30 a.m. EDT to discuss first 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 4485380 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, 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 consolidated statements of comprehensive income / (loss)
    (in € thousand)
        
      For the three-months ended March 31, 
      2021  2020 
    Revenue 11,659  5,135 
           
    Other income – net 147  (57)
    Research and development expenses (11,405) (11,449)
    General and administrative expenses (4,486) (3,525)
           
    Operating loss (4,085) (9,896)
           
    Finance income / (costs) net 5,499  1,607 
           
    Income / (loss) before tax 1,414  (8,289)
    Income taxes (2) 0 
           
    Income / (loss) for the period 1,412

      (8,289)




    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 (1,253) 81 


    Other comprehensive income / (loss)
     

    (1,253


    )
     

    81
     


    Total comprehensive income / (loss)
     

    159
      

    (8,208


    )
         
    Earnings / (loss) per share in per share

     0.01  (0.11)
    (undiluted = diluted)      
           
    Weighted number of common shares outstanding 116,204,455  76,249,901 







    Unaudited consolidated statements of financial position

    (in thousand)
     
     March 31, 2021

    (unaudited)
     December 31, 2020  

    ASSETS  
    Non-current assets  
    Intangible assets1,688  1,718 
    Leasehold improvements and equipment3,030  2,226 
    Long term financial assets18,789  20,042 
    Right-of-use assets  1,151   940 
     24,658  24,926 
    Current assets  
    Cash and cash equivalents240,672  146,854 
    Trade and other receivables4,173  2,439 
    Inventories                435  246 
    Other assets648  1,260 
     245,928 150,799 


    TOTAL ASSETS


    270,586
      

    175,725
     
        
    EQUITY AND LIABILITIES   
    Equity   
        
    Issued capital1,190  983 
    Capital reserves441,644  345,164 
    Fair value reserves467  1,720 
    Accumulated deficit(274,462) (275,874)
    Total equity168,839  71,993 
        
    Non-current liabilities   
        
    Borrowings9,979  231 
    Contract liabilities28,550  35,992 
    Lease liabilities686  482 
    Total non-current liabilities39,215  36,705 
        
    Current liabilities   
        
    Trade and other payables10,974  11,394 
    Borrowings92  92 
    Lease liabilities546  492 
    Contract liabilities50,920  55,049 
    Total current liabilities62,532  67,027 
          
    TOTAL EQUITY AND LIABILITIES270,586  175,725 







    Unaudited consolidated statements of cash flows      
    (in thousand)          
      For the three months ended March 31, 
    Cash flow from operating activities 2021  2020 
    Income / (loss) for the period 1,412  (8,289)
    Adjustments for the period:    
    - Income taxes 2  0 
    - Depreciation and amortization 331  280 
    - Share based payments 1,109  727 
    - Finance income / costs - net (5,499) (1,607)
      (2,645) (8,889)
           
    Change in trade and other receivables (1,735) (750)
    Change in inventories (189) (41)
    Change in other assets 411  0 
    Change in trade, other payables, provisions and contract liabilities (11,822) (6,999)
    Cash used in operating activities (15,980) (16,679)
    Interest received 0  160 
    Paid interest (50) (28)
    Paid income tax (2) 0 
    Net cash used in operating activities (16,032) (16,547)
         
    Cash flow from investing activities    
    Purchase of intangible assets (4) (2)
    Purchase of leasehold improvements and equipment (962) (20)
    Cash received from maturity of financial assets         0          3,736 
    Net cash used for investing activities (966) 3,714 
         
    Cash flow from financing activities    
    Proceeds from issue of common shares 101,860  0 
    Transaction costs related to issue of common shares (6,350) 0 
    Proceeds from borrowings 10,000  0 
    Transaction costs related to borrowings (201) 0 
    Repayment of lease liabilities (92) (128)
    Repayment of borrowings (23)         (773)
    Cash flow from financing activities 105,194  (901)




    Exchange-rate related changes of cash and cash equivalents
     



    5,622
      



    1,265
     
    Net changes to cash and cash equivalents 88,196  (13,734)
    Cash and cash equivalents at the beginning of the period 146,854  95,234 
    Cash and cash equivalents at the end of the period 240,672  82,765 







    Unaudited 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 
                  
    Equity-settled share based payment awards    727       727 
    Loss for the period          (8,289) (8,289)
    Other comprehensive income                     81            81 
    Balance as of March 31, 2020 762  271,178  2,043   (242,797) 31,186 
                  
                  
    Balance as of January 1, 2021 983  345,164  1,720   (275,874) 71,933 
                  
    Issue of common shares 204  94,215       94,419 
    Exercise of share based payment awards 3  1,156       1,159 
    Equity-settled share based payment awards    1,109       1,109 
    Income for the period          1,412  1,412 
    Other comprehensive income                             (1,253)                   (1,253)




    Balance as of March 31, 2021
     



    1,190
      



    441,644
      



    467
       



    (274,462




    )
     



    168,839
     


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