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Affimed N.V. (AFMD)

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  • Affimed Announces Publication of Final Study Results of its Innate Cell Engager Candidate AFM13 in Combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in Blood
    GlobeNewswire

    Affimed Announces Publication of Final Study Results of its Innate Cell Engager Candidate AFM13 in Combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in Blood

    * 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 AFM13AFM13 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 STATEMENTSThis 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 ContactsAlex Fudukidis Head of Investor Relations a.fudukidis@affimed.comMary Beth Sandin Head of Marketing and Communications m.sandin@affimed.com

  • Affimed Reports Third Quarter 2020 Financial Results and Highlights Recent Operational Progress
    GlobeNewswire

    Affimed Reports Third Quarter 2020 Financial Results and Highlights Recent Operational Progress

    * 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 UpdatesAFM13 (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 InformationAffimed 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 StatementsThis 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 ContactAlexander Fudukidis Head of Investor Relations E-Mail: a.fudukidis@affimed.com Tel.: (917) 436-8102Affimed N.V. Unaudited consolidated statements of comprehensive income / (loss) (in € thousand)  For the three months ended September 30For 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, 2019624 241,062 2,063 (221,516) 22,233            Balance as of January 1, 2020 Balance as of January 1, 2020762 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

  • Affimed and Roivant Sciences Announce Licensing and Strategic Collaboration Agreement to Develop and Commercialize Novel Innate Cell Engagers (ICE®) for Multiple Cancer Targets
    GlobeNewswire

    Affimed and Roivant Sciences Announce Licensing and Strategic Collaboration Agreement to Develop and Commercialize Novel Innate Cell Engagers (ICE®) for Multiple Cancer Targets

    * 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 filingHEIDELBERG, 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® PlatformAffimed’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 SciencesRoivant’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 STATEMENTSThis 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 ContactAlex Fudukidis Head of Investor Relations Email: a.fudukidis@affimed.com  Tel.: +1 (917) 436-8102Roivant ContactPaul Davis Email: paul.davis@roivant.com Tel.: +1 (646) 495-5310