AFMD Affimed N.V.

5.23
+0.02  (+0%)
Previous Close 5.21
Open 5.2
52 Week Low 1.42
52 Week High 5.46
Market Cap $461,945,189
Shares 88,326,040
Float 84,773,190
Enterprise Value $354,777,330
Volume 1,515,692
Av. Daily Volume 1,011,376
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Upcoming Catalysts

Drug Stage Catalyst Date
AFM13 (REDIRECT)
CD30-positive peripheral T cell lymphoma (PTCL)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
AFM24
EGFR-expressing solid tumors
Phase 1/2
Phase 1/2
Phase 1/2a cohort 3 is enrolling.
AFM13 + NK cells
CD30-positive lymphomas
Phase 1
Phase 1
Phase 1 initiation of dosing announced October 6, 2020.
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.  

    • The phase 1b study showed a complete response (CR) rate of 46% (objective response rate [ORR] of 88%) at the recommended dose level in patients with relapsed/refractory (R/R) Hodgkin lymphoma, whereas in a separate study MSD's KEYTRUDA demonstrated an ORR of 69% and a CR of 22.4% as a monotherapy
    • Investigators concluded that AFM13 in combination with KEYTRUDA for R/R Hodgkin lymphoma patients was well-tolerated with adverse events that were generally manageable
    • Novel immunotherapy combination worthy of further investigation

    Heidelberg, Germany, November 19, 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 the Phase 1b study…



     

    • The phase 1b study showed a complete response (CR) rate of 46% (objective response rate [ORR] of 88%) at the recommended dose level in patients with relapsed/refractory (R/R) Hodgkin lymphoma, whereas in a separate study MSD's KEYTRUDA demonstrated an ORR of 69% and a CR of 22.4% as a monotherapy
    • Investigators concluded that AFM13 in combination with KEYTRUDA for R/R Hodgkin lymphoma patients was well-tolerated with adverse events that were generally manageable
    • Novel immunotherapy combination worthy of further investigation

    Heidelberg, Germany, November 19, 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 the Phase 1b study of AFM13, a CD30/CD16A innate cell engager (ICE®), in combination with KEYTRUDA was published in Blood, the renowned Journal of the American Society of Hematology. The results demonstrate promising signs of efficacy including an objective response rate (ORR) of 88% at the highest treatment dose, as well as a complete CR of 46%. As a monotherapy, KEYTRUDA demonstrated an ORR of 69% and a CR of 22.4% in the KEYNOTE-087 trial.

    "We showed for the first time that the combination of an ICE® with a PD-1 checkpoint inhibitor can be safely administered with manageable side effects," said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. "The high objective response rate and complete response rate seen in this proof-of-concept study of AFM13 combined with KEYTRUDA are very encouraging and indicate that the activation of innate immunity could improve upon current therapies." 

    The study assessed the safety and efficacy of AFM13 in combination with KEYTRUDA in 30 heavily pre-treated patients with R/R Hodgkin lymphoma. The safety profile for the combination was described as well-tolerated and similar to the known profiles for each agent alone. Most adverse events were low grade and remained manageable with standard-of-care therapies.

    AFM13 presents a novel approach of activating innate immunity through CD16A-directed tumor-cell killing by NK cells and macrophages. The phase 1b study supports the notion that in combination with an established therapy such as an immune checkpoint inhibitor, that releases the brakes on adaptive immune responses, the ICE® AFM13 complements the PD-1 checkpoint inhibitor, thereby triggering both arms of the immune system against tumors.

    Dr. Nancy Bartlett, a medical oncologist and Koman Chair in Medical Oncology at Washington University School of Medicine in St. Louis and lead author on the publication, said, "There is an unmet need for patients with Hodgkin lymphoma who have relapsed or are refractory to current therapies. For these patients, there are no therapies that show durable efficacy. The combination of AFM13 with KEYTRUDA was well tolerated and showed an 88% response rate with a very encouraging 46% complete metabolic response rate in a heavily pretreated patient population.  This exciting data shows that there are potential treatments on the horizon for patients with limited options."

    "Engagement of the innate immune system to kill tumors is novel. The studies of AFM13 and KEYTRUDA in Hodgkin lymphoma, as well as AFM13 in patients with T-cell lymphoma, present exciting approaches to controlling blood cancers that could significantly benefit patients," said Lee Greenberger, Ph.D., Chief Scientific Officer of The Leukemia & Lymphoma Society (LLS), which supported Affimed's clinical study of AFM13 through its Therapy Acceleration Program® (TAP), LLS's strategic venture philanthropy funding initiative. 

    More details about the Phase 1b of AFM13 in combination with KEYTRUDA study can be found at www.clinicaltrials.gov using the identifier NCT02665650.  The article published in Blood, Volume 136, Number 21 can be found here https://bit.ly/2KiL293 .

    About AFM13

    AFM13 is a first-in-class innate cell engager that induces specific and selective killing of CD30-positive tumor cells by engaging and activating natural killer (NK) cells and macrophages, thereby leveraging the power of the innate immune system. AFM13 is Affimed's most advanced ICE® clinical program, and it is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). The study is actively recruiting and can be found at www.clinicaltrials.gov using the identifier NCT04101331.

    Affimed is currently studying AFM13 in combination with cord blood-derived allogeneic natural killer cells in cooperation with the MD Anderson Cancer Center in Houston. The investigator-sponsored Phase 1 study is preparing to administer a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells, the study can be found at www.clinicaltrials.gov using the identifier NCT04074746.

    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.

    About The Leukemia & Lymphoma Society and Therapy Acceleration Program® (TAP)

    The Leukemia & Lymphoma Society® (LLS) is a global leader in the fight against cancer. The LLS mission: cure leukemia, lymphoma, multiple myeloma, and improve the quality of life of patients and their families. LLS TAP is a strategic initiative that builds business alliances and collaborations with biotechnology companies and academic researchers to identify potential breakthrough therapies with the potential to change the standard of care. LLS TAP funds late stage pre-clinical studies, and proof of concept or registrational clinical trials to help advance these more quickly along the drug development and approval pathway. To learn more, visit www.LLS.org.

    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.

    Affimed Investor and Media Contacts

    Alex Fudukidis

    Head of Investor Relations

    a.fu

    Mary Beth Sandin

    Head of Marketing and Communications







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    • Established license and strategic collaboration with Roivant Sciences - $60 million in upfront consideration and up to $2 billion in future milestones
    • Recognized milestone payment from Genentech for initiation of Phase 1 of RO7297089
    • Ended quarter with €97.3 million of cash, cash equivalents and current financial assets with anticipated cash runway into first half of 2023
    • AFM13 pTCL REDIRECT monotherapy study – interim analysis expected during first half of 2021
    • AFM24 (Phase 1/2a) completed cohort 2 and is enrolling and treating patients in cohort 3
    • First patient dosed with preloaded AFM13 allogeneic cord blood-derived natural killer cells at MD Anderson Cancer Center
    • Collaborations formed with NKMax America and Artiva Biotherapeutics to accelerate…
    • Established license and strategic collaboration with Roivant Sciences - $60 million in upfront consideration and up to $2 billion in future milestones
    • Recognized milestone payment from Genentech for initiation of Phase 1 of RO7297089
    • Ended quarter with €97.3 million of cash, cash equivalents and current financial assets with anticipated cash runway into first half of 2023
    • AFM13 pTCL REDIRECT monotherapy study – interim analysis expected during first half of 2021
    • AFM24 (Phase 1/2a) completed cohort 2 and is enrolling and treating patients in cohort 3
    • First patient dosed with preloaded AFM13 allogeneic cord blood-derived natural killer cells at MD Anderson Cancer Center
    • Collaborations formed with NKMax America and Artiva Biotherapeutics to accelerate innate cell engager (ICE®) / NK cell therapy combinations
    • Data from one preclinical and two clinical studies to be presented at upcoming SITC and ASH scientific conferences
    • Conference call and webcast scheduled for November 10, 2020 at 8:30 am EST



    Heidelberg, Germany, November 10, 2020 – 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 three and nine months ended September 30, 2020 and provided an update on clinical and corporate progress.

    "We have made significant progress with regards to executing our strategy by advancing the development of our innate cell engagers as monotherapy and in combinations. The partnership with Roivant Sciences broadens our pipeline and advances AFM32 towards clinical development; proceeds from the deal extend our cash runway into 2023," said Dr. Adi Hoess, CEO of Affimed. "In addition, we have secured important new NK cell collaborations that broaden the development of our lead therapeutic candidates. As we move ahead, we look forward to reporting on progress of the different programs and generating additional data."

    Clinical Stage Program Updates

    AFM13 (CD30/CD16A)

    • AFM13-202, a Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with CD30-positive peripheral T-cell lymphoma (pTCL), has recruited the prespecified number of patients for the preplanned interim analysis. Affimed now expects to complete the interim data analysis during the first half of 2021.
    • AFM13-104, an investigator sponsored Phase 1 study at MD Anderson Cancer Center evaluating the tolerability and efficacy of AFM13 preloaded cord blood-derived NK (cbNK) cells followed by weekly AFM13 monotherapy in patients with refractory CD30 expressing lymphomas, reported that the first patient has completed the first four-week cycle without noteworthy toxicity and has achieved a partial response according to investigator assessment. The patient is intended to receive a second treatment cycle.
    • An oral presentation of the preclinical data from the collaborations with MD Anderson Cancer Center and the University of Washington combining allogeneic cbNK cells preloaded with AFM13 will be presented at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) on November 11th.
    • Two abstracts on studies with AFM13 have been accepted for poster presentation at the 62nd American Society of Hematology Annual Meeting and Exposition (ASH). The data presented will be from Columbia University's AFM13 study in patients with relapsed or refractory CD30-positive lymphoma with cutaneous presentation and data from the German Hodgkin Study Group study in patients with relapsed or refractory Hodgkin Lymphoma.

    AFM24 (EGFR/CD16A)

    • AFM24-101, a Phase 1/2a clinical trial of AFM24, the EGFR/CD16A targeted ICE® for patients with EGFR-expressing solid tumors, completed dose cohort 2 and patients are currently being enrolled and treated in cohort 3.
    • Affimed entered a clinical collaboration to investigate the combination of AFM24 with NKMax America's autologous NK cell therapy, SNK01, in a first-in-human proof of concept (POC) trial in patients with EGFR-expressing tumors. The agreement includes an option to broaden the collaboration to include NKMax America's allogeneic NK cell product. The agreement follows a preclinical collaboration between the two companies that showed synergy between Affimed's ICE® molecules and NKMax America's autologous and cryopreserved allogeneic NK cell products.

    Roivant Sciences Partnership

    • Affimed entered into a licensing and strategic collaboration agreement with Roivant Sciences under which the Company will receive $60 million in upfront consideration, including $40 million in cash and pre-funded R&D and $20 million of Roivant equity, up to an additional $2 billion in future milestones and tiered royalties.
    • Affimed will grant a license to AFM32 with options for additional ICE® molecules directed against targets not included in Affimed's current pipeline.
    • Affimed to be responsible for all preclinical work through IND-filing.
    • Roivant Sciences to form new subsidiary focused on the development and commercialization of ICE®-based therapeutics.
    • Affimed retains certain co-promotional rights.



    Genentech Partnership

    • The Genentech-partnered, novel BCMA-targeted innate cell engager for the treatment of multiple myeloma is treating patients in a first-in-human Phase I, open-label, multicenter, global dose-escalation study designed to evaluate the safety, tolerability, and pharmacokinetics of RO7297089.
    • The initiation of the Phase 1 study triggered a milestone payment recognized in the third quarter.

    Preclinical Pipeline Update

    • AFM28 progressed further in IND-enabling studies and Affimed expects an IND will be filed in the first half of 2022.
    • Affimed entered a R&D collaboration with Artiva Biotherapeutics to develop off-the-shelf, cryopreserved, co-vialed allogeneic natural killer (NK) cell therapeutics pre-loaded with its ICE® compounds.

    Third Quarter 2020 Financial Highlights

    (Figures for the third quarter ended September 30, 2020 and 2019 are unaudited.)

    As of September 30, 2020, cash, cash equivalents and current financial assets totaled €97.3 million compared to €104.1 million on December 31, 2019. The pro forma cash position of the company as of September 30, 2020, including the $40 million of upfront cash proceeds from the Roivant collaboration, would be €131.5 million. During the quarter, the company received net proceeds of approximately €11.6 million under its at-the-market ("ATM") program and a milestone payment from its partnership with Genentech in an undisclosed amount.

    Based on its current operating plan and assumptions, Affimed anticipates that its cash, cash equivalents and current financial assets will support operations into the first half of 2023.

    Net cash used in operating activities for the quarter ended September 30, 2020 was €3.6 million compared to €11.7 million in the third quarter of 2019.

    Total revenue for the third quarter of 2020 was €10.5 million compared with €2.1 million in the third quarter of 2019. Revenue for the third quarter of 2020 and 2019 predominantly relate to the Genentech collaboration (2020: €10.5 million, 2019: €1.9 million). Revenue from the Genentech collaboration in the third quarter 2020 was comprised of revenue recognized for collaborative research services performed during the quarter and the recognition of revenue related to a milestone payment.

    R&D expenses for the third quarter of 2020 were €10.1 million compared to €11.7 million in the third quarter of 2019. Expenses in 2020 relate predominantly to our AFM13 and AFM24 clinical programs as well as to our early stage development and discovery activities.

    G&A expenses for the third quarter of 2020 were €3.5 million compared to €2.8 million in the third quarter of 2019.

    Net loss for the third quarter of 2020 was €6.0 million or €0.07 per common share. For the third quarter of 2019, the company's net loss was €10.9 million or €0.17 per common share.

    The weighted number of common shares outstanding for the quarter ended September 30, 2020 were 86.0 million.

    Affimed encourages shareholders to also review its 6-K filing for the quarter ended September 30, 2020, as filed with the United States Securities and Exchange Commission.

    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, November 10, 2020 at 8:30 a.m. EST to discuss third 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 9847055 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 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

    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 September 30
    For the nine months

    ended September 30
      2020201920202019
          
    Revenue 10,5452,10318,61417,464
          
    Other income – net 10249130332
    Research and development expenses (10,101)(11,721)(33,247)(31,253)
    General and administrative expenses (3,455)(2,790)(9,586)(7,566)
          
    Operating income / (loss) (2,909)(12,359)(24,089)(21,023)
          
    Finance income / (costs) – net (3,057)1,475(2,404)1,655
          
    Income / (loss) before tax (5,966)(10,884)(26,493)(19,368)
          
    Income taxes 000(4)
          
    Income / (loss) for the period (5,966)(10,884)(26,493)(19,372)
          
    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
     (139)(555)(129)(531)
          
    Other comprehensive income / (loss) (139)(555)(129)(531)
          
    Total comprehensive income / (loss) (6,105)(11,439)(26,622)(19,903)
          
          
    Earnings / (loss) per share in € per share (0.07)(0.17)(0.33)(0.31)
    (undiluted = diluted)     
    Weighted number of common shares outstanding 86,030,87862,443,55080,490,15562,437,673

    Affimed N.V.

    Consolidated statements of financial position (in € thousand)

     September 30, 2020 December 31, 2019
     (unaudited)  
    ASSETS   
    Non-current assets   
    Intangible assets93 137
    Leasehold improvements and equipment2,305 2,291
    Long term financial assets3,064 3,193
    Right-of-use assets 1,084 824
     6,546 6,445
    Current assets   
    Cash and cash equivalents89,656 95,234
    Financial assets 7,687 8,902
    Trade and other receivables2,552 1,482
    Inventories410 296
    Other assets1,087 0
     101,392 105,914
    TOTAL ASSETS107,938 112,359
        
    EQUITY AND LIABILITIES   
    Equity   
    Issued capital883 762
    Capital reserves305,301 270,451
    Fair value reserves 1,833 1,962
    Accumulated deficit(261,001) (234,508)
    Total equity47,016 38,667
        
    Non-current liabilities   
    Borrowings 207 278
    Contract liabilities15,203 37,961
    Lease liabilities332 272
    Total non-current liabilities15,742 38,511
        
    Current liabilities   
    Trade and other payables8,123 10,674
    Provisions479 517
    Borrowings1,070 2,105
    Lease liabilities779 532
    Contract liabilities34,729 21,353
    Total current liabilities45,180 35,181
        
    TOTAL EQUITY AND LIABILITIES107,938 112,359

    Affimed N.V.

    Unaudited consolidated statements of cash flows (in € thousand)



    (in € thousand)For the nine months ended September 30
     20202019
    Cash flow from operating activities  
    Income / (loss) for the period(26,493) (19,372)
    Adjustments for the period:   
    - Income taxes0 4
    - Depreciation and amortization821 648
    - Net gain from disposal of leasehold improvements and equipment 0 (9)
    - Share based payments2,348 1,981
    - Finance income / (costs) – net2,404 (1,655)
     (20,920) (18,403)
    Change in trade and other receivables(1,174) 458
    Change in inventories(114) (70)
    Change in other assets (1,087) (1,104)
    Change in trade, other payables, provisions and contract liabilities(12,053) (11,727)
    Cash used in operating activities(35,348) (30,846)
    Interest received299 413
    Paid interest(81) (180)
    Net cash used in operating activities(35,130) (30,613)
        
    Cash flow from investing activities   
    Purchase of intangible assets(8) (143)
    Purchase of leasehold improvements and equipment(352) (926)
    Cash paid for investments in financial assets(8,101) (39,733)
    Cash received from maturity of financial assets9,088 38,270
    Net cash used for investing activities627 (2,532)
        
    Cash flow from financing activities   
    Proceeds from issue of common shares33,846 26
    Transaction costs related to issue of common shares (1,134) 0
    Proceeds from borrowings0 562
    Repayment of lease liabilities(386) (299)
    Repayment of borrowings (1,151) (2,339)
    Cash flow from financing activities31,175 (2,050)
        
    Exchange-rate related changes of cash and cash equivalents(2,250) 361
    Net changes to cash and cash equivalents(3,328) (35,195)
    Cash and cash equivalents at the beginning of the period95,234 94,829
    Cash and cash equivalents at the end of the period89,656 59,995

    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, 2019624 239,055 

     



    2,594
     (202,144) 40,129
     



    Exercise of share based payment awards
     



     
     26     26
    Equity-settled share based

    payment awards
      1,981     1,981
    Loss for the period      (19,372) (19,372)
    Other comprehensive income    

     



    (531)
       (531)
     



    Balance as of September 30, 2019
    624 241,062 2,063 (221,516) 22,233
              
    Balance as of January 1, 2020



    Balance as of January 1, 2020
    762 270,451 1,962 (234,508) 38,667
              
    Issue of common shares121 32,502     32,623
    Equity-settled share based

    payment awards
      2,348     2,348
    Loss for the period      (26,493) (26,493)
    Other comprehensive income    (129)   (129)


     



    Balance as of September 30, 2020


     



    883
     305,301 1,833 (261,001) 47,016

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  2.  

    • Affimed to grant license to AFM32 with options for additional ICE® molecules directed against targets not included in Affimed's current pipeline
    • Affimed to receive $60 million in upfront consideration and up to an additional $2 billion in future milestones
    • Affimed to be responsible for all preclinical work through IND filing

    HEIDELBERG, Germany; BASEL, Switzerland; and NEW YORK, November 9, 2020  Affimed N.V. (NASDAQ:AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, and Roivant Sciences, a global biopharmaceutical company, today announced that they have entered into a licensing and strategic collaboration agreement to develop and commercialize novel ICE® molecules…



     

    • Affimed to grant license to AFM32 with options for additional ICE® molecules directed against targets not included in Affimed's current pipeline
    • Affimed to receive $60 million in upfront consideration and up to an additional $2 billion in future milestones
    • Affimed to be responsible for all preclinical work through IND filing

    HEIDELBERG, Germany; BASEL, Switzerland; and NEW YORK, November 9, 2020  Affimed N.V. (NASDAQ:AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, and Roivant Sciences, a global biopharmaceutical company, today announced that they have entered into a licensing and strategic collaboration agreement to develop and commercialize novel ICE® molecules in oncology.

    The collaboration grants Roivant a license to the preclinical molecule AFM32. The collaboration will also leverage Affimed's proprietary Redirected Optimized Cell Killing (ROCK®) platform to generate ICE® molecules against targets not included in Affimed's current pipeline.

    Under the terms of the agreement, Affimed will receive $60 million in upfront consideration, comprised of $40 million in cash and pre-paid R&D funding, and $20 million of newly issued shares in Roivant. Affimed could receive further short-term proceeds in the form of option fees contingent on the commencement of additional programs contemplated under the agreement. The company is eligible to receive up to an additional $2 billion in milestones over time upon achievement of specified development, regulatory and commercial milestones, as well as tiered royalties on net sales.

    Pursuant to the agreement, Affimed will be primarily responsible for driving the discovery and research phases of molecule development through filing of the IND. Roivant will be responsible for clinical development and commercialization worldwide, and Affimed retains an option for co-promotion.

    "This partnership represents an important milestone as it further validates our platform and scientific expertise in the selection of promising targets to develop ICE® molecules in oncology indications where patients are underserved by existing therapies," said Dr. Adi Hoess, Affimed's Chief Executive Officer. "Partnering with Roivant, an innovative trailblazer in biopharmaceutical development, is another step towards accelerating the growth of our current and future pipeline."

    "We are extremely pleased to have entered into this agreement with Affimed given their leadership position in the science of innate immunity and extensive expertise in the preclinical development of bispecifics," commented Dr. Roger Sidhu, Chief Medical Officer and Head of R&D at Roivant. "We look forward to working together to deliver meaningful therapies to patients."

    About the ROCK® Platform

    Affimed's proprietary, fit-for-purpose ROCK® platform technology generates diverse, tetravalent, bispecific antibodies known as innate cell engagers (ICE®) which can be customized to target specific binding domains on hematologic and solid tumor cells. Affimed's ROCK® -generated ICE® use a distinct, dual mechanism of action that activates CD16A on natural killer cells and macrophages and binds to specific antigens on tumor cells, restoring the body's innate ability to overcome tumor invasion and destroy tumor cells.

    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.

    About Roivant Sciences

    Roivant's mission is to improve the delivery of healthcare to patients by treating every inefficiency as an opportunity. Roivant develops transformative medicines faster by building technologies and developing talent in creative ways, leveraging the Roivant platform to launch Vants – nimble and focused biopharmaceutical and health technology companies. For more information, please visit www.roivant.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 AFM32, 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.

    Affimed Contact

    Alex Fudukidis

    Head of Investor Relations

    Email:  

    Tel.: +1 (917) 436-8102

    Roivant Contact

    Paul Davis

    Email:

    Tel.: +1 (646) 495-5310

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  3.  

    • Virtual data presentation at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting on Wednesday, November 11, 2020

    Heidelberg, Germany, November 9, 2020 – Affimed N.V. (NASDAQ:AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that preclinical data – generated through a collaboration with The University of Texas MD Anderson Cancer Center and Washington University School of Medicine – will be the focus of an oral presentation at the virtual Annual Meeting of the Society for Immunotherapy of Cancer (SITC), identifying promising combinations of Innate Cell Engager (ICE®) AFM13 with cytokine-activated adult blood or cord blood natural…



     

    • Virtual data presentation at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting on Wednesday, November 11, 2020

    Heidelberg, Germany, November 9, 2020 – Affimed N.V. (NASDAQ:AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, announced today that preclinical data – generated through a collaboration with The University of Texas MD Anderson Cancer Center and Washington University School of Medicine – will be the focus of an oral presentation at the virtual Annual Meeting of the Society for Immunotherapy of Cancer (SITC), identifying promising combinations of Innate Cell Engager (ICE®) AFM13 with cytokine-activated adult blood or cord blood natural killer (NK) cells against CD30-positive hematological malignancies. Nancy D. Marin, PhD, of Washington University School of Medicine will present these data virtually on Wednesday, November 11, 2020 from 3:45 – 5:15 p.m. EST during the session, "Innate Immunity: The Next Generation of Targets for Anti-Cancer Immunotherapy."

    "The current set of preclinical in vitro and in vivo data demonstrate the increased efficacy of AFM13-preloaded cord blood-derived NK cells towards CD30-positive tumor cells," said Arndt Schottelius, M.D. PhD, Affimed's Chief Scientific Officer. "We are excited about these data that laid the groundwork for the ongoing Phase 1 evaluation of this combination to treat patients suffering from CD30+ malignancies."

    NK cell-based immunotherapies represent an emerging field of targeting hard-to-treat cancers. To evaluate the potential of innate cell engagers (ICE®) to trigger NK cell-directed tumor cell killing, the collaborative research analyzed AFM13-mediated tumor cell killing in combination with several NK cell products, including conventional (c)NK cells from healthy donors, NK cells from patients with Hodgkin Lymphoma, cytokine-induced memory-like (ML) NK cells from peripheral blood and preactivated and expanded cord blood (cb) NK cells. Affimed's tetravalent bispecific ICE® AFM13 binds to CD30, a protein found on tumor cells, as well as CD16A, a molecule found on NK cells and macrophages, triggering the innate immune system to initiate tumor-cell killing. The cbNK cells were then stably pre-loaded with AFM13, enhancing responses to CD30+ lymphomas in vitro and in vivo in immunodeficient NSG mouse models.

    AFM13-preloaded cNK cells from healthy donors exhibited superior responses versus those from Hodgkin lymphoma patients suggesting that the source of NK cells impacts tumor cell killing. IL-12, IL-15, and IL-18-induced ML NK cells exhibited enhanced killing of CD30+ lymphoma cells when directed by AFM13, compared to cNK cells. Similarly, AFM13 combined with cord-blood expanded NK cells that were pre-activated with IL-12, IL-15 and IL-18 also exhibited tumor cell killing compared to expanded cb NK cells.

    "ICE® molecules combined with NK cells have the potential to improve tumor cell killing of hard-to-treat cancers," said Dr. Marin from Washington University School of Medicine. "Based on this data, a patient with NK cells rendered dysfunctional could see meaningful benefit when adding cytokine-activated cord blood cells or ML NK cells to enhance the tumor cell killing of AFM13, helping restore functionality to their depleted NKs and innate immune system."

    "The use of cbNK cells complexed with AFM13 to target lymphomas expressing CD30 represents a novel approach to immunotherapy. This technique has the potential to be extended to other cancer targets in the future, transforming pre-complex NK cells into de facto CAR NK cells, thus providing a rapid pathway for translating new NK cell therapies into the clinic," said first author Lucila Kerbauy, M.D., who led the work as a postdoctoral fellow at MD Anderson.

    The presented data formed the basis of an Investigational New Drug (IND) Application and further substantiate the rationale for combining AFM13 with adoptive NK cell-based therapies,  as is being currently investigated in a Phase I clinical study at MD Anderson (NCT04074746). Additionally, these new data and methodology are also being used in a Phase I study with AFM24 – Affimed's tetravalent, bispecific ICE® that binds to EGFR on tumor cells and CD16A on innate immune cells – in EGFR-positive advanced solid tumors to characterize NK cell phenotypes in patients (NCT04259450).

    For more information visit the SITC website at www.sitcancer.org/2020/home.

    About AFM13

    AFM13 is a first-in-class CD30/CD16A ROCK®-derived bispecific innate cell engager (ICE®) that induces specific and selective killing of CD30-positive tumor cells by engaging and activating natural killer (NK) cells and macrophages, thereby leveraging the power of the innate immune system. AFM13 is Affimed's most advanced ICE® clinical program, and it is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma (REDIRECT). The study is actively recruiting and can be found at www.clinicaltrials.gov using the identifier NCT04101331.

    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.

    Affimed Investor and Media Contacts

    Alex Fudukidis

    Head of Investor Relations

    Mary Beth Sandin

    Head of Marketing and Communications





     

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  4.  

    • Exclusive collaboration to assess feasibility and activity of pre-manufactured, co-vialed, cryopreserved, off-the-shelf NK cell combination therapeutics targeting EGFR and additional targets
    • Proof of concept, preclinical assessment to establish activity and feasibility of the combination of Artiva's allogeneic natural killer (NK) cells and Affimed's innate cell engagers (ICE®)

    San Diego and Heidelberg, Germany, November 5, 2020 -- Artiva Biotherapeutics, Inc., and Affimed N.V. (NASDAQ:AFMD), both immuno-oncology companies focused on developing and commercializing therapies utilizing the innate immune system, announced today that they have entered into an exclusive collaboration agreement to assess combining elements of their respective…

     

    • Exclusive collaboration to assess feasibility and activity of pre-manufactured, co-vialed, cryopreserved, off-the-shelf NK cell combination therapeutics targeting EGFR and additional targets
    • Proof of concept, preclinical assessment to establish activity and feasibility of the combination of Artiva's allogeneic natural killer (NK) cells and Affimed's innate cell engagers (ICE®)

    San Diego and Heidelberg, Germany, November 5, 2020 -- Artiva Biotherapeutics, Inc., and Affimed N.V. (NASDAQ:AFMD), both immuno-oncology companies focused on developing and commercializing therapies utilizing the innate immune system, announced today that they have entered into an exclusive collaboration agreement to assess combining elements of their respective platforms in the generation of targeted, off-the-shelf allogeneic NK cell therapies.

    The R&D collaboration will assess the feasibility and preclinical activity of combinations of Artiva's allogeneic NK cell product AB-101 and Affimed's ICE® molecules, building on earlier preclinical studies demonstrating synergistic cytotoxic activity. Under the agreement, Affimed's ICE® molecules targeting EGFR and other undisclosed targets will be combined with Artiva's GMP-grade allogeneic NK cells during the cell manufacturing process. The pre-manufacturing process will include the loading of AB-101 with Affimed ICE® molecules prior to cryopreservation, creating specifically targeted allogeneic cells without the requirement for viral transduction. The resulting cryopreserved, off-the-shelf, targeted allogeneic NK cell products will be assessed for anti-tumor activity and development potential. The costs of manufacturing and preclinical assessments will be shared by both companies. The agreement provides for potential further development of selected combination products.

    "The combination of Artiva's highly scaled, optimized NK-cell manufacturing platform with Affimed's tumor-targeting ICE® molecules has the potential for an efficient and flexible therapeutic combination product platform, and preclinical assessments have already demonstrated the potential of this approach," said Tom Farrell, President and CEO of Artiva. "Our NK cells are activated during the manufacturing process resulting in high and consistent expression of innate tumor engagement receptors, including CD16A, making them the ideal platform to combine with tumor-specific targeting ICE® from Affimed's platform."

    "The collaboration with Artiva represents a visionary approach which can lead to a new class of drugs providing a potent and targeted innate immune system-cytotoxic response," said Dr. Adi Hoess, Affimed's Chief Executive Officer. "Our ROCK® platform has been proven to rapidly and predictably generate a set of diverse innate cell engagers, with consistent profiles in tumor lysis and safety making our ICE® molecules optimally suited for combination therapy with NK cells."

    Using its ROCK® (Redirected Optimized Cell Killing) platform, Affimed has developed a novel pipeline of ICE® products; tetravalent, bispecific therapeutics specific for tumor targets such as epidermal growth factor receptor (EGFR) and CD30 and maintaining high affinity CD16A-binding for enhanced activation of innate immunity, inducing both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).

    Artiva's AB-101 is a universal NK cell therapy for use in combination with monoclonal antibodies or novel modalities such as NK cell engagers. In preclinical studies, AB-101 has demonstrated enhanced antibody-dependent cellular cytotoxicity with a variety of therapeutic antibodies. The company plans to enter the clinic this year with AB-101, assessing monotherapy safety and efficacy and subsequent therapeutic potential in combination with an anti-CD20 monoclonal antibody for the treatment of relapsed refractory B-cell lymphoma. The first batches of AB-101 drug product, manufactured at very large scale and cryopreserved in infusion-ready media, have already been produced for clinical use.

    About Artiva Biotherapeutics: Scaling NK Cell Therapy for Cancer

    Artiva's mission is to deliver to cancer patients highly effective cellular immunotherapies that are also safe and immediately accessible. Artiva's pipeline of universal and targeted NK cell therapies leverages the innate anti-tumor biology and safety features of NK cells. The therapies are optimized for enhanced efficacy through chimeric antigen receptors (CARs) or therapeutic antibody combination therapy. Artiva's pipeline leverages a manufacturing platform that supports large-scale production and cryopreservation of off-the-shelf allogeneic NK cell therapies and proprietary CAR-NK technologies to augment therapeutic activity. Artiva's platform incorporates cell expansion, activation, and engineering technology developed by the company's corporate partner, GC LabCell, a member of the GC family of companies, one of the Republic of Korea's leading biopharmaceutical groups. Artiva is headquartered in San Diego. For more info, please visit www.artivabio.com.

    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 intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of Affimed's ROCK® platform, ICE® product candidates and AFM24, the potential of Artiva's NK cell, CAR-NK cell, and AB-101 products, the potential benefits of combining Affimed's ICE product candidates with Artiva's NK cell technology, and preclinical development and clinical trials, 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 neither company assumes any obligation to update these forward-looking statements, even if new information becomes available in the future.

    Artiva Media Contact

    Jessica Yingling, Ph.D.

    Little Dog Communications

    E-Mail:

    Tel.: +1 (858) 344-8091 

    Affimed Investor Contact

    Alexander Fudukidis

    Head of Investor Relations

    E-Mail:

    Tel.: +1 (917) 436-8102

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