AFMD Affimed N.V.

4.57
-0.16  -3%
Previous Close 4.73
Open 4.79
52 Week Low 1.42
52 Week High 4.79
Market Cap $348,462,048
Shares 76,249,901
Float 72,697,051
Enterprise Value $264,156,210
Volume 1,093,613
Av. Daily Volume 1,580,254
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Drug Pipeline

Drug Stage Notes
AFM24
EGFR-expressing solid tumors
Phase 1/2
Phase 1/2
Phase 1/2a completion of first cohort announced June 17, 2020. Noted no efficacy yet was observed, however, efficacy was not expected at this dose level.
AFM13
CD30-positive peripheral T cell lymphoma (PTCL)
Phase 2
Phase 2
Phase 2 dosing has been initiated - noted November 19, 2019.
AFM13
Hodgkin Lymphoma - Cancer
Phase 2
Phase 2
Phase 2a ongoing.
AFM13 with Keytruda
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%.
AFM11
Non-Hodgkin lymphoma (NHL) and acute lymphoblastic leukemia (ALL)
Phase 1
Phase 1
Phase 1 program terminated - noted May 22, 2019.

Latest News

  1.              

    • AFM24: Affimed successfully completed the first dose cohort of its first-in-human phase 1/2A Study; Cohort 2 is open for patient recruitment
    • Data on Affimed's AFM24 (EGFR/CD16A) and Genentech's RO7297089 (BCMA/CD16A) was presented at AACR Virtual Meeting II, showing potent killing of tumor cell lines and a good safety profile in the relevant pre-clinical models
    • AFM13: Continued progress on the REDIRECT monotherapy study in pTCL as well as on the AFM13 combination with cbNk investigator sponsored study at MD Anderson Cancer Center in CD30-positive T cell lymphoma
    • Management: Appointed Angus Smith as Chief Financial Officer, following the appointments of Dr. Andreas Harstrick as Chief Medical Officer and Dr. Arndt Schottelius as Chief…

                 

    • AFM24: Affimed successfully completed the first dose cohort of its first-in-human phase 1/2A Study; Cohort 2 is open for patient recruitment
    • Data on Affimed's AFM24 (EGFR/CD16A) and Genentech's RO7297089 (BCMA/CD16A) was presented at AACR Virtual Meeting II, showing potent killing of tumor cell lines and a good safety profile in the relevant pre-clinical models
    • AFM13: Continued progress on the REDIRECT monotherapy study in pTCL as well as on the AFM13 combination with cbNk investigator sponsored study at MD Anderson Cancer Center in CD30-positive T cell lymphoma
    • Management: Appointed Angus Smith as Chief Financial Officer, following the appointments of Dr. Andreas Harstrick as Chief Medical Officer and Dr. Arndt Schottelius as Chief Scientific Officer earlier in the year, completing the management team
    • Conference call and webcast scheduled for June 23, 2020 at 8:30 am EDT (2:30 pm CET)

    Heidelberg, Germany, June 23, 2020 – Affimed N.V. (NASDAQ:AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, today reported financial results for the first quarter 2020 and provided an update on clinical and corporate progress.

    "We continue to move our clinical programs forward in close collaboration with our investigators and partners," said Dr. Adi Hoess, CEO of Affimed. "We have strengthened the management team with the recent hiring of Angus Smith as CFO, which nicely complements the additions of Dr. Andreas Harstrick as CMO and Dr. Arndt Schottelius as CSO earlier in the year.  With good progress in our clinical programs, the pre-clinical pipeline and the completion of the management team, we are well positioned to increase our leadership position as innovators of innate immune system-based therapeutics."

    Development Program Updates

    AFM13 (CD30/CD16A)

    • Affimed has successfully activated 46 clinical study sites in nine countries in the on-going Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with CD30-positive peripheral T-cell lymphoma (pTCL).
    • The investigator-sponsored Phase 1 study with the University of Texas, MD Anderson Cancer Center to investigate the combination of AFM13 with allogeneic NK cells in CD30+ Lymphomas has completed the required validation work in order to administer a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells.

                 

    AFM24 (EGFR/CD16A)

    • After the successful completion of  dose cohort 1, in the first-in-human Phase 1/2a clinical trial of AFM24, the EGFR/CD16A targeted innate cell engager for relapsed/ refractory patients with advanced EGFR-expressing solid tumors, the study was cleared to begin patient recruitment in dose cohort 2. The company reported that no dose limiting toxicity was observed in dose cohort 1.  
    • Affimed researchers presented preclinical data on the pharmacology and safety of AFM24 at the AACR Virtual Annual Meeting II.

    Genentech Collaboration Update

    • In May 2020, Affimed confirmed that its novel BCMA targeted innate cell engager for the treatment of multiple myeloma has been partnered with Genentech, a member of the Roche Group.
    • Researchers from Genentech and Affimed co-authored a poster on the preclinical pharmacology and safety data of RO7297089 and presented data at the AACR Virtual Annual Meeting II.
    • On clinicaltrials.gov, Genentech has posted a first-in-human Phase I, open-label, multicenter, global, dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of RO7297089.

    Preclinical Pipeline Update

    • Affimed continues to progress AFM28 and AFM32 towards late stage preclinical development.

    Management Appointments

    • Angus Smith was appointed to the position of Chief Financial Officer in June and will join the company in mid-July. Mr. Smith brings broad biopharmaceutical experience to the company including financial strategy and planning, capital markets, business development and operations.
    • The company announced the additions of Dr. Andreas Harstrick as Chief Medical Officer and Dr. Arndt Schottelius as Chief Scientific Officer earlier in the year. Dr. Harstrick, brings broad development expertise in solid tumor indications, including EGFR-expressing cancers. Dr. Schottelius brings extensive innate immunity expertise and a successful record of advancing discovery research into preclinical and clinical development.

    First Quarter 2020 Financial Highlights

    (Figures for the first quarter ended March 31, 2020 and 2019 are unaudited.)

    As of March 31, 2020, cash, cash equivalents and current financial assets totaled €88.2 million compared to €104.1 million on December 31, 2019. In addition, the company raised €18.8 million (based on an exchange rate of $/€ of 1.1210 on June 19, 2020) net proceeds under its at-the-market ("ATM") program. The pro forma cash position of the company as of March 31, 2020, including the net proceeds from the ATM, would be €107.0 million. Based on its current operating plan and assumptions, Affimed anticipates that its cash, cash equivalents and current financial assets will support operations well into the first half of 2022.

    Net cash used in operating activities for the quarter ended March 31, 2020, was €16.5 million, compared to €13.4 million for the quarter ended March 31, 2019. The increase is primarily due to higher expenditure related to research and development efforts.

    Total revenue for the quarter ended March 31, 2020, was €5.1 million compared to €11.4 million for the same period of 2019. Revenue in both quarters is primarily attributable to the recognition of revenue from the Genentech collaboration in the respective years.

    R&D expenses for the quarter ended March 31, 2020, were €11.4 million compared to research and development expenses of €8.0 million for the same period of 2019. The increase was primarily related to higher expenses for the AFM13 registration-directed study in pTCL, manufacturing activities for AFM13 clinical study material, and early stage development and discovery activities.

    General and administrative (G&A) expenses for the quarter ended March 31, 2020, were €3.5 million compared to €2.4 million for the quarter ended March 31, 2019. The increase was primarily related to higher personnel expenses, a result of the strengthening of the talent pool, higher SOX compliance costs, legal, consulting and audit costs.

    Net loss was €8.3 million, or €0.11 per common share, for the quarter ended March 31, 2020, compared to a net income of €1.9 million, or €0.03 per common share, for the quarter ended March 31, 2019.

    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, Tuesday, June 23, 2020 at 8:30 a.m. EDT to discuss first quarter 2020 financial results and recent corporate developments. The conference call will be available via phone and webcast. To access the call, please dial +1 (646) 741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference passcode 8594214 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. Affimed's fit-for-purpose ROCK® platform allows innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and into a Phase 1/2a dose escalation/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. For more information, 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 AFM24, 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 Contact:

    Alex Fudukidis

    Head of Investor Relations

    E-Mail:

    Tel.: (917) 436-8102



    Affimed N.V.

    Unaudited consolidated statements of comprehensive income / (loss) (in € thousand)

     For the three months ended March 31 
       2020 2019
    Revenue  5,135 11,353
    Other income – net  (57) 86
    Research and development expenses  (11,449) (7,987)
    General and administrative expenses  (3,525) (2,434)
    Operating income / (loss)  (9,896) 1,018
    Finance income / (costs) – net  1,607 834
    Income / (loss) before tax  (8,289) 1,852
          
    Income / (loss) for the period  (8,289) 1,852
          
    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  81 73
          
    Other comprehensive income / (loss)  81 73
          
    Total comprehensive income / (loss)  (8,208) 1,925
          


    Earnings / (loss) per share in € per share




    (undiluted = diluted)
      (0.11) 0.03
    Weighted number of common shares outstanding  76,249,901 62,430,106



    Affimed N.V.

    Consolidated statements of financial position (in € thousand)

      March 31, 2020 December 31, 2019
     (unaudited)  
    ASSETS   
    Non-current assets   
    Intangible assets121 137
    Leasehold improvements and equipment2,193 2,291
    Long term financial assets3,274 3,193
    Right-of-use assets679 824
     6,267 6,445
    Current assets   
    Cash and cash equivalents82,765 95,234
    Financial assets5,476 8,902
    Trade and other receivables2,171 1,482
    Inventories337 296
     90,749 105,914
        
    TOTAL ASSETS97,016 112,359
        
    EQUITY AND LIABILITIES   
    Equity   
    Issued capital762 762
    Capital reserves271,178 270,451
    Fair value reserves2,043 1,962
    Accumulated deficit(242,797) (234,508)
    Total equity31,186 38,667
        
    Non-current liabilities   
    Borrowings  254 278
    Contract liabilities30,430 37,961
    Lease liabilities155 272
    Total non-current liabilities30,839 38,511
        
    Current liabilities   
    Trade and other payables8,434 10,674
    Provisions  497 517
    Borrowings  1,401 2,105
    Lease liabilities522 532
    Contract liabilities  24,137 21,353
    Total current liabilities34,991 35,181
    TOTAL EQUITY AND LIABILITIES97,016 112,359

    Affimed N.V.

    Unaudited consolidated statements of cash flows (in € thousand)

       For the three months ended March 31
       



     
    2020 2019
    Cash flow from operating activities    
    Income / (loss) for the period (8,289) 1,852
    Adjustments for the period:    
    - Depreciation and amortization 280 210
    - Net gain from disposal of leasehold improvements and equipment 0 (9)
    - Share based payments   727 601
    - Finance income / costs – net   (1,607) (834)
      (8,889) 1,820
    Change in trade and other receivables (750) (6,688)
    Change in inventories (41) (65)
    Change in other assets   0 (183)
    Change in trade, other payables, provisions and contract liabilities (6,999) (8,252)
    Cash used in operating activities (16,679) (13,368)
    Interest received 160 62
    Paid interest (28) (77)
    Net cash used in operating activities (16,547) (13,383)
         
    Cash flow from investing activities    
    Purchase of intangible assets (2) (64)
    Purchase of leasehold improvements and equipment (20) (66)
    Cash paid for investments in financial assets   0 (21,061)
    Cash received from maturity of financial assets 3,736 3,513
    Net cash used for investing activities 3,714 (17,678)
         
     



    Cash flow from financing activities
        
    Repayment of lease liabilities (128) (82)
    Repayment of borrowings  (773) (833)
    Cash flow from financing activities (901) (915)
         
    Exchange-rate related changes of cash and cash equivalents 1,265 236
    Net changes to cash and cash equivalents (13,734) (31,976)
    Cash and cash equivalents at the beginning of the period 95,234 94,829
    Cash and cash equivalents at the end of the period 82,765 63,089

    Affimed N.V.

    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, 2019
     624 239,055  



     



    2,594
     (202.144) 40,129
    Equity-settled share based

    payment awards 
       601     601
    Income for the period       1,852 1,852
    Other comprehensive income      



     



    73
       73
               
    Balance as of

    March 31, 2019
     624 239,656  



    2,667
     (200,292) 42,655
               
               
    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

    Primary Logo

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    • Data Presented at AACR Virtual Annual Meeting II demonstrate that Affimed's ROCK® platform has the ability to produce diverse Innate Cell Engagers for a multitude of hematologic and solid tumor cancers with consistent profiles in tumor lyses and safety
    • Data on both Affimed's AFM24 (CD16A/EGFR) and Genentech's RO797089 (CD16A/BCMA) show potent killing in tumor cell lines at low target expression in the relevant pre-clinical models
    • Both Innate Cell Engagers show dual Mode of Action through activation of CD16A on NK cells and macrophages, inducing ADCC and ADCP respectively
    • In cynomolgus monkeys both AFM24 and RO7297089 demonstrate a promising safety profile

    Heidelberg, Germany, June 22, 2020 – Affimed N.V. (NASDAQ:AFMD), a clinical-stage immuno-oncology…



    • Data Presented at AACR Virtual Annual Meeting II demonstrate that Affimed's ROCK® platform has the ability to produce diverse Innate Cell Engagers for a multitude of hematologic and solid tumor cancers with consistent profiles in tumor lyses and safety
    • Data on both Affimed's AFM24 (CD16A/EGFR) and Genentech's RO797089 (CD16A/BCMA) show potent killing in tumor cell lines at low target expression in the relevant pre-clinical models
    • Both Innate Cell Engagers show dual Mode of Action through activation of CD16A on NK cells and macrophages, inducing ADCC and ADCP respectively
    • In cynomolgus monkeys both AFM24 and RO7297089 demonstrate a promising safety profile

    Heidelberg, Germany, June 22, 2020 – 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 data from two investigational Innate Cell Engagers (ICE) developed from its fit-for-purpose ROCK® platform were presented as posters at the American Association for Cancer Research (AACR) Virtual Annual Meeting II. Affimed researchers presented data on AFM24, a bispecific EGFR/CD16A ICE with the potential to overcome resistance to current targeted treatments for EGFR-positive malignancies.  Researchers from Genentech, a member of the Roche Group, presented preclinical data on the pharmacology and safety of RO7297089, a novel anti-BCMA/CD16A bispecific antibody for the treatment of multiple myeloma built from the ROCK® platform; Affimed researchers contributed as co-authors on the poster.

    "The data presented at AACR on AFM24 and RO7297089 further confirm the importance of activating the innate immune system to deliver transformative medicines to patients," said Dr. Arndt Schottelius, Affimed's Chief Scientific Officer.  "Moreover, it is very exciting to see that both molecules show potent and targeted killing of tumor cells in vitro without high levels of cytokine release. With AFM24, we have already progressed to the 2nd dose cohort in our Phase 1/2A clinical study and very much look forward to seeing continued consistent safety profile and early signs of activity in future cohorts."

    AFM24 activates innate immunity to kill solid tumors, inducing both ADCC and ADCP

    The data presented on Affimed's AFM24 further elucidated its preclinical profile as a novel ICE that harnesses the innate immune system to induce potent tumor cell killing via ADCC and ADCP.  Due to its distinctive mechanism of action (MOA), AFM24 is potentially eligible for treatment of EGFR-positive tumors, regardless of EGFR-pathway mutations and EGFR receptor density.  Unlike other EGFR targeted therapies, EGFR is used as a docking site only, AFM24's cytotoxicity is independent of EGFR functionality and the downstream signal cascade. The pre-clinical data suggest that AFM24 is well tolerated with no toxicity in cynomolgus monkeys. Based on its preclinical profile, AFM24 shows promising therapeutic benefit for a broad set of patients with hard-to-treat EGFR-expressing cancers. AFM24 is currently being studied in a Phase1/2A study.

    RO7297089 shows potent cell killing of BCMA positive tumor cell lines employing NK cells and macrophages

    The data presented on Genentech's RO7297089 provided preclinical characterization of a novel BCMA/CD16A ICE, also based on the ROCK® platform, for the treatment of multiple myeloma. It was shown that RO7297089 is a potent therapeutic agent in vitro and selectively kills BCMA expressing multiple myeloma tumor cells by activating innate immunity (ADCC and ADCP). The in vitro assessment demonstrated that, unlike T cell redirecting therapies, RO7297089 is unlikely to have a risk of acute cytokine release.  In a one-month repeat-dose study in cynomolgus monkeys, RO7297089 was well tolerated, and there were no test article-related adverse effects at up to 50 mg/kg, with no significant cytokine release.  RO7297089 represents a novel and promising MOA with a favorable safety profile, distinct from the T cell-based BCMA-targeting modalities in the clinic.

    More details about the program for the AACR Virtual Annual Meeting II including the abstracts and poster presentations on AFM24 and RO7297089 are available online at www.aacr.org.

    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. Affimed's fit-for-purpose ROCK® platform allows innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and into a Phase 1/2a dose escalation/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. For more information, 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 AFM24, 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 Securities and Exchange Commission. 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 Contact

    Alex Fudukidis, Head of Investor Relations

    Email:  

    Primary Logo

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  2.  

    • AFM24, designed to activate innate immunity to broadly target EGFR-expressing solid tumors regardless of mutational status, has the potential to improve efficacy and safety over currently available EGFR-targeted therapies
    • AFM24 is the first innate cell redirecting immuno-oncology therapeutic dosed in solid tumor patients
    • The 2nd dose cohort is open for patient recruitment

    Heidelberg, Germany, June 17, 2020 – Affimed N.V. (NASDAQ:AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the successful completion of the first dose cohort in a Phase 1/2a clinical trial of AFM24. This first-in-human study evaluates AFM24 as monotherapy in patients with advanced solid…



     

    • AFM24, designed to activate innate immunity to broadly target EGFR-expressing solid tumors regardless of mutational status, has the potential to improve efficacy and safety over currently available EGFR-targeted therapies
    • AFM24 is the first innate cell redirecting immuno-oncology therapeutic dosed in solid tumor patients
    • The 2nd dose cohort is open for patient recruitment

    Heidelberg, Germany, June 17, 2020 – Affimed N.V. (NASDAQ:AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the successful completion of the first dose cohort in a Phase 1/2a clinical trial of AFM24. This first-in-human study evaluates AFM24 as monotherapy in patients with advanced solid EGFR expressing malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24, a tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding innate cell engager, is novel due to its activation of innate immunity to kill solid tumors, inducing both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). Other therapies rely heavily on signal or checkpoint inhibition.

    The company reports that no dose limiting toxicity was observed and the study is cleared to proceed the next dose level (cohort 2).  No efficacy yet was observed, however, efficacy was not expected at this dose level. 

    "As we progress to the 2nd dose cohort, we take another step closer to giving patients a new treatment option with a distinctive mechanism that mobilizes the innate immune system to attack cancer cells" said Dr. Andreas Harstrick, Chief Medical Officer of Affimed. "The innate immune system is inherently powerful, yet it has been largely untapped as a therapeutic approach to fight cancer. With the clinical progress we are making we are hopeful that AFM24 will become an important option to provide long-lasting, multilayered tumor control."

    AFM24 has demonstrated preclinically the ability to bridge NK cells and macrophages to EGFR-expressing tumor cell lines, and to induce lysis through ADCC and ADCP, respectively, independent of RAS or BRAF mutational status.

    The study is an open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study to evaluate AFM24 as monotherapy in adult patients with advanced solid malignancies known to be EGFR-positive. The aim of the dose escalation phase is the determination of the maximum tolerated dose and the establishment of a recommended Phase 2a dose. The dose expansion phase is intended to collect preliminary evidence of efficacy and to further confirm the safety of AFM24. For more information including eligibility criteria, visit www.clinicaltrials.gov, using Identifier NCT04259450.

    About AFM24

    AFM24 is a tetravalent, bispecific EGFR- and CD16A-binding innate cell engager generated from Affimed's fit-for-purpose ROCK® platform. AFM24 uses the cytotoxic potential of the innate immune system by redirecting and activating NK cells and macrophages to kill EGFR-positive cancer cells through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), respectively. Due to its unique mechanism of action, AFM24 is potentially not limited to patient subtypes based on mutational status. Toxicology studies in cynomolgus monkeys with AFM24 showed a favorable safety profile, even when the animals were treated at high dose levels, demonstrating AFM24's potential to have lower toxicities in humans compared to other EGFR-targeted therapies.

    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. Affimed's fit-for-purpose ROCK® platform allows innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and into a Phase 1/2a dose escalation/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. For more information, 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 AFM24, 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 Securities and Exchange Commission. 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 & Media Contact:

    Alex Fudukidis, Head of Investor Relations

    E-Mail:

    Primary Logo

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  3. Heidelberg, Germany, June 16, 2020 – 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 first quarter 2020 results on Tuesday, June 23, 2020 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 first quarter results call, please dial +1-646-741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference conference ID 8594214 approximately 15 minutes prior to the call.

    To access the live audio webcast of the conference call please visit the "Investors" section…



    Heidelberg, Germany, June 16, 2020 – 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 first quarter 2020 results on Tuesday, June 23, 2020 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 first quarter results call, please dial +1-646-741-3167 for U.S. callers, or +44 (0) 2071 928338 for international callers, and reference conference ID 8594214 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.

    BMO Conference Participation

    Affimed also announced that its Chief Executive Officer, Dr. Adi Hoess, will participate in a fireside chat at the 2020 BMO Prescriptions for Success Healthcare Conference on Tuesday, June 23, at 1:30 p.m. EDT.

    A live webcast of the fireside chat will be available on the "Investors" section of the company's website at https://www.affimed.com/investors/webcasts_cp?/. A replay of the fireside chat will be archived on the Affimed website for 30 days following the event.

    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. Affimed's fit-for-purpose ROCK® platform allows innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and into a Phase 1/2a dose escalation/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. For more information, please visit www.affimed.com.

    Investor & Media Contact:

    Alex Fudukidis

    Head of Investor Relations

    E-Mail:

    Tel: (917) 436-8102

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  4.  Mr. Smith brings broad financial management and US capital markets expertise

    Heidelberg, Germany, June 11, 2020 – Affimed N.V. (NASDAQ:AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the appointment of Angus Smith as Chief Financial Officer, completing Affimed's leadership team. Mr. Smith will begin his employment on July 13, 2020 and will be based out of Affimed's New York office.

    Mr. Smith has broad biopharmaceutical industry experience including financial strategy, capital markets, business development and operations. He joins Affimed from Rockwell Medical, Inc., where he served as Chief Financial Officer.

    "We are pleased to…



     Mr. Smith brings broad financial management and US capital markets expertise

    Heidelberg, Germany, June 11, 2020 – Affimed N.V. (NASDAQ:AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced the appointment of Angus Smith as Chief Financial Officer, completing Affimed's leadership team. Mr. Smith will begin his employment on July 13, 2020 and will be based out of Affimed's New York office.

    Mr. Smith has broad biopharmaceutical industry experience including financial strategy, capital markets, business development and operations. He joins Affimed from Rockwell Medical, Inc., where he served as Chief Financial Officer.

    "We are pleased to welcome Mr. Smith who adds extensive US capital markets expertise," said Dr. Adi Hoess, Affimed's CEO. "His biopharmaceutical industry experience and track record of financial execution for life sciences companies will help ensure that Affimed is well positioned as we enter the next stage of rapid growth."

    "This is an exciting time to join Affimed and I look forward to contributing to the success of the company as it progresses its clinical and pre-clinical programs," said Mr. Smith.  "I look forward to applying my experience in late-stage pharmaceuticals in order to evolve the company and accelerate our ability to bring much needed therapeutics to cancer patients who deserve more options."

    Prior to Rockwell, a biopharmaceutical company focused on developing and commercializing therapies for anemia, Mr. Smith served as Senior Vice President, Chief Business Officer and Principal Financial Officer at Pernix Therapeutics, a specialty pharmaceutical company focused on the acquisition, development and commercialization of prescription drugs. 

    Mr. Smith began his career in healthcare investment banking, having served as a Director in the Healthcare Investment Banking Group at Cantor Fitzgerald. During his nearly decade-long investment banking tenure, Mr. Smith focused on providing strategic and financial advice to life sciences and healthcare companies.  He has worked on a substantial number of transactions across the healthcare sector with an aggregate transaction value of more than $15 billion.

    Mr. Smith holds a B.A. in Mathematical Economics from Colgate University.  

    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. Affimed's fit-for-purpose ROCK® platform allows innate cell engagers to be designed for specific patient populations. The company is developing single and combination therapies to treat hematologic and solid tumors. The company is currently enrolling patients into a registration-directed study of AFM13 for CD30-positive relapsed/refractory peripheral T cell lymphoma and into a Phase 1/2a dose escalation/expansion study of AFM24 for the treatment of advanced EGFR-expressing solid tumors. For more information, 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 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 and the risks, uncertainties and other factors described under the heading "Risk Factors" in Affimed's filings with the Securities and Exchange Commission. 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 and Media Contacts

    Alex Fudukidis

    Head of Investor Relations

    Tel.: (917) 436-8102

    E-Mail:

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