GlobeNewswire Inc | Apr 15, 2021 06:30AM EDT

April 15, 2021

-- AFM13 monotherapy: Reported positive data from the preplanned interim analysis for the registration-directed trial in PTCL -- AFM13 combination with NK cells: Announced 100% objective response rate in four response evaluable patients, including 2 complete responses -- AFM24 monotherapy: AFM24 (phase 1/2a study) completed cohort 4 and is enrolling and treating patients in cohort 5; expansion cohorts expected to start in the second half of 2021 -- AFM24 combination with NK cells: IND application cleared by the FDA for the combination of AFM24 with NKGen Biotechs SNK-01 NK autologous cell therapy -- AFM24 combination with anti PD-L1 antibody: Established a collaboration with Roche to clinically explore the combination of AFM24 with atezolizumab (Tecentriq) -- Made continued progress in advancing and forming partnerships with Genentech and Roivant, which triggered payments to Affimed -- Pro forma cash and cash equivalents as of December 31, 2020 were approximately 244.5 million (inclusive of Q1 equity offering and loan proceeds) with anticipated cash runway into the second half of 2023 -- Conference call and webcast scheduled for April 15, 2021 at 8:30 a.m. EDT

Heidelberg, Germany, April 15, 2021 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 year ended December 31, 2020 and provided an update on clinical and corporate progress.

2020 was an important year for Affimed. We continued to build on the strong foundation of our scientific discoveries and made significant progress across all our programs. We broadened our clinical pipeline, added new collaborations, built a strong balance sheet, appointed key senior management executives and ensured that our programs stayed on track through the global pandemic, said Dr. Adi Hoess, CEO of Affimed. We entered 2021 with strong momentum, and the recently announced positive outcome of our interim futility analysis for our registration directed study of AFM13 as monotherapy in PTCL patients, and initial data from the trial investigating AFM13 pre-complexed natural killer cells in Hodgkin lymphoma patients provide further validation for our three-pronged development strategy. As we look ahead into 2021, we anticipate numerous additional updates as we advance our programs.

Clinical Stage Program Updates

Three-pronged Development Strategy

Based on preclinical and clinical data, Affimed is pursuing development of its innate cell engagers (ICE) as monotherapy, and in combination with adoptive NK cell transfer and PD-1/PD-L1 checkpoint inhibitors.

AFM13 (CD30/CD16A)

-- In March 2021, Affimed reported positive results from the preplanned interim futility analysis for AFM13-202, its phase 2 registration-directed study of AFM13 (CD16A/CD30) as monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL). The futility analysis demonstrated that the response rate in Cohort A achieved the predefined threshold for continuation of the study. The response rate in Cohort B was sufficiently comparable to allow merging of both cohorts into a single cohort for all patients with CD30 >1%, per the study protocol. Evidence of anti-tumor response was observed in both cohorts with complete and partial responses. The trial will continue by combining the high- and low-CD30 expressing cohorts into one. -- In April 2021, Affimed reported positive initial clinical data from the investigator sponsored trial (IST) at The University of Texas MD Anderson Cancer Center evaluating increasing doses of cord-blood derived NK cells pre-complexed with AFM13 (CD16A/CD30) followed by three weekly infusions of AFM13 monotherapy in patients with recurrent or refractory CD30 positive lymphomas. As of March 31, 2021, all four response evaluable patients, including three patients in cohort 1 (1x106 AFM13-cbNK/kg) and one patient in cohort 2 (1x107 AFM13-cbNK/kg), have achieved an objective response, including two complete responses, according to investigator assessments by Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC). All four patients had relapsed / refractory Hodgkin lymphoma and were heavily pretreated, with between four and 14 previous lines of therapy which in all cases included brentuximab vedotin (Adcetris) and anti-PD1 antibodies.

AFM24 (EGFR/CD16A)

-- AFM24-101, the phase 1/2a clinical trial of AFM24, the EGFR/CD16A targeted ICE for patients with EGFR-expressing solid tumors, completed dose cohort 4 (160 mg) and patients are currently being enrolled and treated in dose cohort 5 (320 mg). Affimed expects to provide an update on the dose escalation and initiate the dose expansion cohortsduring 2021. -- An investigational new drug (IND) application was cleared by the U.S. Food and Drug Administration to investigate the combination of AFM24 with NKGen Biotechs (formerly known as NKMax America) autologous NK cell therapy, SNK01, in a first-in-human proof of concept (POC) trial in patients with EGFR-expressing tumors. Affimed expects to initiate the study in the second half of 2021. -- Affimed entered into a clinical collaboration with Roche for a phase 1/2a study evaluating AFM24 in combination with the PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) in EGFR-expressing solid tumors. The phase 1 portion of the study will establish a dosing regimen and assess safety for the combination; in the subsequent phase 2a portion of the study, the clinical activity of the combination will be evaluated in specific tumor types. Affimed expects to initiate the study in the second half of 2021. -- Preclinical data was presented at AACR 2021 showing the potential of AFM24 as monotherapy and in combination with NK cells. As monotherapy, AFM24 induces tumor cell killing independent of KRAS mutations; and, in combination with adoptive NK cells, it leads to AFM24 dose-dependent tumor regression.

Preclinical and Partnered Programs

-- AFM28 progressed further in IND-enabling studies and Affimed expects an IND application will be filed in the first half of 2022. -- In November 2020, Affimed entered into a licensing and strategic collaboration agreement with Roivant Sciences and granted Roivant a license to AFM32 with options for additional ICE molecules against targets not included in Affimeds current pipeline. AFM32 will be investigated in solid tumors. -- In August 2020, Affimed announced that Genentechs RO7297089, a CD16A/BCMA targeting ICE, is actively recruiting patients into a first-in-human phase 1 trial resulting in the achievement of a milestone payment under the terms of the collaboration. -- Affimed entered a collaboration with Artiva Biotherapeutics to assess feasibility and activity of pre-manufactured, co-vialed, cryopreserved, off-the-shelf NK cell combination therapeutics. The R&D collaboration is assessing the feasibility and preclinical activity of combinations of Artivas allogeneic NK cell product AB-101 and Affimeds ICE molecules, building on earlier preclinical studies demonstrating synergistic cytotoxic activity.

Other Corporate Updates

-- In January 2021, Affimed completed a $115 million underwritten public offering to accelerate and expand the development and manufacturing of its clinical and preclinical ICE molecules. -- In January 2021, Affimed entered into a financing agreement with Silicon Valley Bank for up to 25 million in term loans, with 10 million available at closing.

Full Year 2020 Financial Highlights

As of December 31, 2020, cash, cash equivalents and current financial assets totaled 146.9 million compared to 104.1 million on December 31, 2019. The pro forma cash position as of December 31, 2020, including net proceeds from the January 2021 underwritten public offering and the first tranche of the Silicon Valley Bank loan, would be approximately 244.5 million.

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

Net cash used in operating activities for the year ended December 31, 2020 amounted to 19.4 million compared to 29.1 million for the year ended December 31, 2019. The amount received in 2020 includes an initial upfront payment and committed funding of 33.3 million (US$ 40 million) from the Roivant collaboration.

Total revenue for the year ended December 31, 2020 was 28.4 million compared with 21.4 million for the year ended December 31, 2019. Revenue for 2020 and 2019 predominantly relate to the Genentech collaboration. Collaboration revenue for the year ended December 31, 2020 amounted to 27.8 million, with 26.2 million from the Genentech collaboration and 1.4 million from the Roivant collaboration. Collaboration revenue of 19.7 million for the year ended December 31, 2019 was from the Genentech collaboration.

Research and development expenses for 2020 increased 14.2% from 43.8 million in the year ended December 31, 2019 to 50.0 million in the year ended December 31, 2020, due to higher expenses for AFM24 and our other projects and infrastructure investments.

General and administrative expenses increased 33.6% from 10.3 million in the year ended December 31, 2019 to 13.7 million in the year ended December 31, 2020. In 2020, general and administrative expenses were largely comprised of personnel expenses of 6.3 million and legal, consulting and audit costs of 5.6 million.

Finance costs for the year ended December 31, 2020 were 6.6 million, compared to finance income of 15 thousand for the year ended December 31, 2019. Finance costs for the year ended December 31, 2020 were largely comprised of foreign exchange losses related to assets denominated in U.S. dollars as a result of the weakening of the U.S. dollar compared to the Euro during the year.

Net loss for the year ended December 31, 2020 was 41.4 million, or 0.50 per common share compared with a net loss of 32.4 million, or 0.50 per common share, for the year ended December 31, 2019.

The weighted number of common shares outstanding for the year ended December 31, 2020 was 83.5 million.

Additional information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2020 and Item 5. Operating and Financial Review and Prospects, which will be included in Affimeds Annual Report on Form 20-F as filed with the U.S. Securities and Exchange Commission (SEC).

Note on International Financial Reporting Standards (IFRS)

Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information

Affimed will host a conference call and webcast today, April 15, 2021 at 8:30 a.m. EDT to discuss fourth quarter, year-end 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 4271307 approximately 15 minutes prior to the call.

A live audio webcast of the conference call will be available in the Webcasts section on the Investors page of the Affimed website at https://www.affimed.com/investors/webcasts_cp/. A replay of the webcast will be accessible at the same link for 30 days following the call.

About Affimed N.V.

Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The companys proprietary ROCK platform enables a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors, enabling a broad pipeline of wholly-owned and partnered single agent and combination therapy programs. The ROCK platform predictably generates customized innate cell engager (ICE) molecules, which use patients immune cells to destroy tumor cells. This innovative approach enabled Affimed to become the first company with a clinical-stage ICE. Headquartered in Heidelberg, Germany, with offices in New York, NY, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by a bold vision to stop cancer from ever derailing patients lives. For more about the companys people, pipeline and partners, please visit: www.affimed.com.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as anticipate, believe, could, estimate, expect, goal, intend, look forward to, may, plan, potential, predict, project, should, will, would and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, and our other product candidates, the value of our ROCK platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation and the risks, uncertainties and other factors described under the heading Risk Factors in Affimeds 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 FudukidisDirector, Head of Investor RelationsE-Mail: a.fudukidis@affimed.comTel.: +1 (917) 436-8102

Affimed N.V.

Consolidated statements of comprehensive income / (loss) (in thousand)

2020 2019 2018

28,360 21,391 23,735RevenueOther income - net 626 290 1,515Research and development expenses (49,989) (43,791) (35,148)General and administrative expenses (13,715) (10,266) (9,638)

(34,718) (32,376) (19,536)Operating lossFinance income / (costs) - net (6,647) 15 60

(41,365) (32,361) (19,476)Loss before taxIncome taxes (1) (4) (1)

(41,366) (32,365) (19,477)Loss for the period

Other comprehensive income / (loss)Items that will not be reclassified toprofit or loss Equity investments at fair value OCI - netchange infair value (242) (632) (4,731)

(242) (632) (4,731)Other comprehensive income / (loss)

(41,608) (32,997) (24,208)Total comprehensive Loss

Earnings / (loss) per share in ? per (0.50) (0.50) (0.32)share (undiluted = diluted)Weighted number of common shares 83,471,559 64,242,396 60,514,407outstanding

Affimed N.V.Consolidated statements of financial position (in thousand)

December 31, 2020 December 31, 2019ASSETSNon-current assets Intangible assets 1,718 137Leasehold improvements and equipment 2,226 2,291Long term financial assets 20,042 3,193Right-of-use assets 940 824 24,926 6,445Current assets Cash and cash equivalents 146,854 95,234Financial assets 0 8,902Trade and other receivables 2,439 1,482Inventories 246 296Other assets 1,260 0 150,799 105,914TOTAL ASSETS 175,725 112,359EQUITY AND LIABILITIES Equity Issued capital 983 762Capital reserves 345,164 270,451Fair value reserves 1,720 1,962Accumulated deficit (275,874) (234,508)Total equity 71,993 38,667Non-current liabilities Borrowings 231 278Contract liabilities 35,992 37,961Lease liabilities 482 272Total non-current liabilities 36,705 38,511Current liabilities Trade and other payables 11,394 10,674Provisions 0 517Borrowings 92 2,105Lease liabilities 492 532Contract liabilities 55,049 21,353Total current liabilities 67,027 35,181TOTAL EQUITY AND LIABILITIES 175,725 112,359

Affimed N.V.Consolidated statements of cash flows (in thousand)

2020 2019 2018Cash flow fromoperating activitiesIncome / (loss) for the (41,366) (32,365) (19,477)periodAdjustments for the period:- Income taxes 1 4 1- Depreciation and 1,115 906 403amortisation- Net gain / loss fromdisposal of leasehold 34 (5) 25improvements andequipment- Share based payments 3,381 2,469 2,035- Finance income / 6,647 (60)costs - net (15) (30,188) (29,006) (17,073)Change in trade and (1,065) 33 (322)other receivablesChange in inventories 50 (36) (19)Change in other assets (1,260) 340 121Change in trade, otherpayables, provisions 12,848 66,856and contract (791)liabilitiesCash used in operating (19,615) (29,460) 49,563activitiesInterest received 294 628 218Paid interest (78) (224) (342)Paid income tax (1) 0 (1)Net cash used in (19,400) (29,056) 49,438operating activitiesCash flow from investing activitiesPurchase of intangible (9) (150) (30)assetsPurchase of leaseholdimprovements and (431) (1,324) (691)equipmentCash received from thesale of leasehold 0 0 1improvements andequipmentCash paid forinvestments in (8,101) (45,131) (14,029)financial assetsCash received frommaturity of financial 16,547 50,945 0assetsCash paid forinvestments in long 0 0 (861)term financial assetsNet cash used for 8,006 4,340 (15,610)investing activitiesCash flow from financing activitiesProceeds from issue of 74,195 31,373 25,113common sharesTransaction costsrelated to issue of (2,294) (2,215) (1,701)common sharesProceeds from 0 562 0borrowingsRepayment of lease (521) (405) 0liabilitiesRepayment of borrowings (2,128) (3,277) (2,917)Cash flow from 69,252 26,038 20,495financing activities



Exchange-rate relatedchanges of cash and (6,238) (917) 669cash equivalentsNet changes to cash and 57,858 1,322 54,323cash equivalentsCash and cashequivalents at the 95,234 94,829 39,837beginning of the periodCash and cashequivalents at the end 146,854 95,234 94,829of the period

Affimed N.V.Consolidated statements of changes in equity (in thousand)

Fair value Accumulated Issued capital Capital reserves reserves deficit Total equityBalance as ofJanuary 1, 468 213,778 7,325 (182,667) 38,9042018 Issue of 156 23,171 23,327common sharesExercise ofshare based 71 71payment awardsEquity-settledshare based 2,035 2,035payment awardsLoss for the (19,477) (19,477)periodOther comprehensive (4,731) (4,731)incomeBalance as ofDecember 31, 624 239,055 2,594 (202,144) 40,1292018

Balance as of January 1, 624 239,055 2,594 (202,144) 40,1292019 Issue of 138 28,901 29,039common sharesExercise ofshare based 26 26payment awardsEquity-settledshare based 2,469 2,469payment awardsLoss for the (32,365) (32,365)periodOther comprehensive (632) (632)incomeBalance as ofDecember 31, 762 270,451 1,962 (234,508) 38,6672019



Balance as ofJanuary 1, 762 270,451 1,962 (234,508) 38,6672020 Issue of 205 68,341 68,546common sharesExercise ofshare based 16 2,991 3,007payment awardsEquity-settledshare based 3,381 3,381payment awardsLoss for the (41,366) (41,366)periodOther comprehensive (242) (242)incomeBalance as ofDecember 31, 983 345,164 1,720 (275,874) 71,9932020