Announcement • Nov 03

Affimed N.V. Announces Oral Presentation of Phase 1/2 Data from AFM13 in Combination with Allogeneic NK Cells at the 2023 ASH Annual Meeting

Affimed N.V. announced two upcoming presentations on its lead innate cell engager (ICE®?) AFM13 at the American Society of Hematology (ASH) 2023 Annual Meeting. In the first presentation, Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center and principal investigator of the study, will present the updated results from the AFM13-104 phase 1/2 trial evaluating AFM13 in combination with cord blood-derived natural killer (cbNK) in patients with CD30-positive relapsed or refractory (r/r) Hodgkin and non-Hodgkin lymphomas in an oral presentation, on December 11, 2023 at 11:45 a.m. PST /2:45 p.m. EST. A total of 42 patients were enrolled in the study with 36 patients treated at the RP2D. All patients were heavily pretreated and refractory to their most recent line of therapy with active progressive disease at the time of enrollment. As of the July 2023 cut-off date for data presented in the abstract, the treatment regimen achieved an objective response rate (ORR) of 94.4% with a complete response rate of 72.2% in the patients treated at the RP2D. In addition, the treatment regimen demonstrated a good safety and tolerability profile with no cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS) or graft versus host disease (GVHD) of any grade. Across all dose levels as of the cutoff date, median event free survival (EFS) and overall survival (OS) were 8 months and not reached, respectively. A more in-depth analysis of the data and updated EFS/OS data using a later cut-off date will be presented during Dr. Nieto’s oral presentation. The second presentation will be a poster featuring the design of Affimed’s phase 2 LuminICE-203 clinical trial investigating AFM13 in combination with Artiva’s AlloNK® (also known as AB-101), an allogeneic, non-genetically modified NK cell therapy candidate. The open-label, multi-center, multi-cohort study (NCT05883449) study is based on the unprecedented results achieved in the investigational AFM13-104 study and will evaluate the efficacy and safety of the combination in patients with r/r HL and certain r/r CD30+ PTCL subtypes. Affimed has recently received Fast-track designation for the AFM13/AB-101 combination. Details of AFM13 Oral Presentation and Abstract: Title: Innate Cell Engager (ICE®) AFM13 Combined with Preactivated and Expanded (P+E) Cord Blood (CB)-Derived Natural Killer (NK) Cells for Patients with Refractory CD30-Positive Lymphomas: Final Results Session: Cellular Immunotherapies: Early Phase and Investigational Therapies: Novel Approaches to Enhance Cellular Therapies and Immune Responses in Leukemias and Lymphomas Date & Time:Monday, December 11, 2023 at 11:45 a.m. PST Location: San Diego Convention Center, Room 6CF. Details of LuminICE-203 Poster Presentation: Title: AFM13 in Combination with Allogeneic Natural Killer Cells (AB-101) in Relapsed or Refractory Hodgkin Lymphoma and CD30+ Peripheral T-Cell Lymphoma: A Phase 2 Study (LuminICE). Session: Cellular Immunotherapies: Early Phase and Investigational Therapies: Poster III Session Date & Time:Monday, December 11, 2023 from 6:00 p.m. - 8:00 p.m. PST Location:San Diego Convention Center, Halls G-H. The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-sponsored phase 1/2 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The study is a dose-escalation trial of precomplexed NK cells, followed by an expansion phase, recruiting up to 40 patients with r/r CD30 positive lymphomas, treated with the RP2D of1×108 NK cells/kg) followed by three weekly doses of 200 mg AFM13 monotherapy. Each treatment cycle consists of lymphodepleting chemotherapy with fludarabine (30 mg/m² per day) and cyclophosphamide (300 mg/m² per day) followed two days later by a single infusion of cytokine-preactivated and expanded cord blood-derived NK cells that are pre-complexed with AFM13. Three weekly infusions of AFM13 (200 mg) monotherapy are subsequently administered and responses are assessed by the investigator on day 28 by FDG-PET. AFM13 is a first-in-class innate cell engager (ICE®) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is a tetravalent bispecific innate cell engager designed to act as a bridge between the innate immune cells and the tumor creating the necessary proximity for the innate immune cells to specifically destroy the tumor cells.

Seeking Alpha • Jun 29

Affimed: Preparing For Key Inflection Points

Affimed has generated an impressive pipeline of innate cell engagers programs created using their three-pronged development strategy. These programs target high unmet needs and large market opportunities. Affimed recently finalized a $103.5M public offering, which will help fund the company’s wholly-owned programs to hit key catalysts over the remainder of 2022 and into 2023. The company has planned updates on all three of their wholly-owned programs for the second half of this year. The company is on track for registration-directed studies. I am looking to make one or more discretionary additions in the near term to take advantage of the present share price and will return to a DCA strategy. Despite my bullish outlook, I have put AFMD in the Compounding Healthcare speculative "Bio Boom" Portfolio with a conviction grade of 3 out of 5. Over the past few years, Affimed (AFMD) has constructed a distinguished pipeline of innate cell engagers and has verified their three-pronged development strategy to move the company closer to the next stage of growth. In recent times, Affimed has expanded its R&D prowess and revealed significant proof-of-concept data in heavily pretreated patients with a combination of an innate engager and allogeneic natural killer cells. Moreover, Affimed recently finalized a $103.5M public offering, which will help fund the company's wholly-owned programs to hit key catalysts over the remainder of 2022 and into 2023. Sadly, none of this progress has been able to fend off the selling pressure that has crushed small-cap biotechs over the past year and AFMD is now trading just above its 52-week lows. I believe this is an opportunity to add to my AFMD position ahead of some key inflection points that could spark a potential turnaround in the share price. I intend to provide a brief background on the company and will discuss some upcoming catalysts that could trigger a potential turnaround. In addition, I go over some downside risks that investors should be aware of. Finally, I take a look at the charts to identify some key levels and highlight my strategy for adding to my AFMD position. Background on Affimed Affimed is a biotechnology company that utilizes their "fit-for-purpose" Rock platform to develop "innate cell engagers" or "ICE Molecules". The platform creates multi-specific antibodies that will unlock the body's immune cells to attach to their target that is specific to an indication. Affimed's ICE Molecules link to natural killer "NK" cells and macrophages by the CD16A-binding area, while concurrently binding to the target cancer cells. This connection will allow the innate immune system to engage the cancer cells and will trigger the release of perforins to create holes in the cancer cell's membrane to allow granzymes to initiate apoptosis of the cancer cell. ICE Molecule ( Affimed) Rock Platform Overview (Affimed) It is important to note that the company's ICE Molecules are taking the innate immune system that had essentially missed cancer in the first place and has now allowed it to attack the cancer cells. Moreover, Affimed's ICE molecules won't require harvesting the patient's NK or T-Cells, which gives it a significant advantage over most cell therapies. Affimed's pipeline is filled with ICE Molecule programs in an assortment of indications both as a monotherapy and combination therapies. Affimed Method ( Affimed) The company's lead candidate, AFM13, is being tried as a monotherapy, as well as in adaptive NK cells combo, and in combination with an anti-PD-1 in CD30+ lymphomas. To date, AFM13 has generated impressive data both as a monotherapy and in combination. AFM13 Key Data (Affimed) Extraordinarily, the NK cell combination (AFM13-104) showed inspiring results in 40 heavily pre-treated patients that had a median of six prior lines of therapy. 13 of these patients in the highest dose responded to the treatment with 5 of them undergoing a complete response. Moreover, one of these patients had previously failed CD30 CAR-T therapy. AFM13+NK Cell Combo Complete Response (Affimed) Currently, Affimed has completed enrollment in AFM13's registration-directed study in peripheral T-cell lymphoma. AFM13 has been a proof-of-concept product candidate for Affimed and has the potential to validate the remainder of the company's pipeline programs both as monotherapies and in combination therapies. Affimed Pipeline (Affimed) The company's AFM24 is taking aim at EGFR+ solid tumors, which over 400K patients in the U.S. and 1.5M patients around the world. AFM28 is targeting CD123 in AML which is ready for an IND in the first half of this year. AFM28 is the company CD123 targeting innate cell engager is preparing for IND for acute myeloid leukemia. AFM28 encourages lysis of CD123-positive leukemic blasts in AML patients, either pre-complexed or co-administered with cryopreserved NK cells. In addition to the company's wholly-owned assets, Affimed has partnered programs ROIVANT and Roche's (OTCQX:RHHBY) Genentech. These programs have already provided notable milestone payments and the company still has billions in potential milestones outstanding. Upcoming Inflection Points The company's platform, pipeline, and partnerships should produce several potent catalysts over the coming quarters that should improve the company's outlook and potentially fuel a turnaround in the share price. Affimed Upcoming Inflection Points (Affimed) My focus will primarily be on AFM13, which has completed enrollment for the monotherapy REDIRECT study for relapsed/refractory PTCL. Affimed anticipates topline data from this study in Q4 of this year. So far, the AFM13+NK cells combo has displayed a robust increase in complete responses following two cycles of the recommended Phase II dose. Affimed is moving forward and expects to update investors on its development later this year and potentially present data at a medical conference in the second half of this year. Affimed continues to enroll patients in all three AFM24 clinical trials and is planning to present data in the second half of this year. This should reveal the efficacy of the company's three-pronged strategy. The company recently presented data at EHA that showed AFM28 produced potent anti-tumor activity with "no evidence of off-target cytotoxicity." AFM28 is on track for an IND this month for relapsed and refractory AML. Affimed anticipates starting the Phase I clinical trial in the second half of this year. Affimed is also working with their partners to safeguard access to an off-the-shelf cryo-preserved natural killer cell to use in the development of the company's ICE therapies. Affimed expects to update on their NK cell development strategy in the second half of 2022. Affimed is also working with their partnered programs including their Genentech programs. Affimed has been working on several preclinical programs and has handed them over to Genentech for further preclinical development. Affimed's partnership with Roivant is still pushing AFM32 forward and is in IND-enabling studies. Affimed is eligible for additional milestones in the near term. Turnaround Potential Affimed made significant progress in the first half of 2022 with AFM13, AFM24, and AFM28, all of them showing potential to address major medical needs using the company's three-pronged strategy. The planned updates on all three programs for the second half of this year will keep the company on track to be among the first companies to bring innate cell engagers to registration-directed studies and potentially to the market. But most importantly, Affimed extended the company's cash runway to mid-2024, which allows the company to run past these key inflection points for all their innate cell engagers. Affimed Overview (Affimed ) So, not only does the company have several scheduled for the second half of this year, but they also have adequate cash position to get them through the docket of events. As a result, I suspect these updates will have a durable impact on the share price. Whereas underfunded biotech tickers typically experience a selloff in the subsequent weeks as investors fear a follow-up secondary offering. What is more, Affimed has the potential to collect upsized milestone payments from their partners that could extend that cash runway projection beyond mid-2024. It is possible that we are looking at a biotech that is approaching registration trials with a healthy cash position and has the potential to collect additional milestone payments to add to the coffers. To me, these seem like the conditions needed to entice the market to permit a turnaround in the share price. Downside Risks to Consider Affimed investors need to consider a few looming downside risks when managing their position. First is cash... which is not an immediate threat at the moment. However, Affimed might have to pull the trigger on an offering in order to fund their pipeline and prepare for commercialization. Therefore, investors need to accept there is a strong risk the company will have to perform some form of dilutive funding, which could have a negative impact on the share price. Another risk comes from a potential regulatory failure or weak clinical data. The company is fixated on their Rock Platform and their ICE molecules, so a miss or setback in any one of their programs could cast doubt on all their pipeline programs. Last but not least is competition from other cell therapy companies. At the moment, Affimed has a long list of competitors who are using NK cells and T cells to take on various cancers. Even if Affimed is able to produce best-in-class results in the clinic, the company is going to have to battle in the market to establish a beachhead while several other cell therapy products attempt to do the same. This could make the first few quarters of commercialization a little rocky, which would most likely hurt the share price until the company can prove their products can compete in the market. As a result, I have put AFMD in the Compounding Healthcare speculative "Bio Boom" Portfolio with a conviction grade of 3 out of 5. Charting Out the Strategy In my previous article, I discussed how was going to "take my AFMD position out of mothball and apply some profits in the coming months while it is still trading under $5.00 per share." At that time, I was looking to employ a DCA approach by making additions every couple of weeks until the charts show signs of a potential reversal as long as the share price was below $4.50 per share. I am still going to stick to that strategy, but I am also looking to make one or more discretionary additions in the near term to take advantage of the present share price.

Biotechs Industry Growth	17.04%
Revenue growth rate	n/a
Return on equity	n/a
Net Margin	n/a
Last Earnings Update	30 Sep 2024

Date	Revenue	Earnings	G+A Expenses	R&D Expenses
30 Sep 24	6	-70	19	50
30 Jun 24	7	-79	20	62
31 Mar 24	9	-93	22	75
31 Dec 23	14	-106	25	93
30 Sep 23	21	-119	27	108
30 Jun 23	34	-111	30	113
31 Mar 23	39	-101	32	108
31 Dec 22	43	-86	32	97
30 Sep 22	42	-76	31	93
30 Jun 22	36	-76	30	87
31 Mar 22	38	-76	27	88
31 Dec 21	42	-58	24	81
30 Sep 21	41	-49	21	71
30 Jun 21	43	-38	18	60
31 Mar 21	36	-32	15	50
31 Dec 20	29	-41	14	50
30 Sep 20	22	-39	12	46
30 Jun 20	14	-44	12	47
31 Mar 20	15	-43	11	47
31 Dec 19	21	-32	10	44
30 Sep 19	41	-11	11	43
30 Jun 19	39	-12	10	41
31 Mar 19	35	-9	10	37
31 Dec 18	24	-19	10	35
30 Sep 18	2	-35	9	28
30 Jun 18	2	-31	8	24
31 Mar 18	2	-31	8	22
31 Dec 17	2	-30	8	21
30 Sep 17	3	-29	8	22
30 Jun 17	3	-31	9	25
31 Mar 17	5	-32	9	28
31 Dec 16	6	-32	9	30
30 Sep 16	7	-33	8	31
30 Jun 16	7	-30	8	29
31 Mar 16	7	-27	8	26
31 Dec 15	8	-20	8	22
30 Sep 15	7	-19	8	19
30 Jun 15	7	-5	6	15

Data	Last Updated (UTC time)
Company Analysis	2026/05/07 11:45
End of Day Share Price	2026/05/07 00:00
Earnings	2024/09/30
Annual Earnings	2023/12/31

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
James Birchenough	BMO Capital Markets Equity Research
Brian Abrahams	Jefferies LLC
Daina Graybosch	Leerink Partners LLC

Affimed Past Earnings Performance

Past criteria checks 0/6

Key information

Recent past performance updates

Affimed N.V. to Report Q3, 2024 Results on Nov 14, 2024

Affimed N.V. to Report Q2, 2024 Results on Sep 05, 2024

Affimed N.V. to Report Q1, 2024 Results on Jun 12, 2024

Affimed N.V. to Report Fiscal Year 2023 Results on Mar 28, 2024

Affimed N.V. to Report Q3, 2023 Results on Nov 14, 2023

Second quarter 2023 earnings: EPS and revenues miss analyst expectations

Recent updates

The Nasdaq Stock Market to Delist the Common Stock of Affimed N.V

Affimed N.V. announced delayed 20-F filing

ASH 2024 Updates Will Validate Clinical Proof Of Concept

Affimed Reports Positive Clinical Update on AFM24/Atezolizumab Combination Therapy in Non-Small Cell Lung Cancer (NSCLC)

Affimed Reports Promising Phase 1 Efficacy and Safety Data for AFM28 in Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)

Affimed Announces Positive Results Demonstrating Safety and Efficacy of Acimtamig and AlloNK® Combination in Relapsed/Refractory Classical Hodgkin Lymphoma (R/R cHL) Patients

Affimed N.V. to Report Q3, 2024 Results on Nov 14, 2024

Affimed N.V. Announces Acceptance of Three Abstracts At the 2024 Ash Annual Meeting Including an Oral Presentation Underscoring Advancing Clinical Pipeline in Leukemia and Lymphoma

Affimed Follow Up: Upcoming Acimtamig And AFM24 Updates Could Be Positive Catalysts

Affimed N.V. Announces Chief Executive Officer Changes

Affimed N.V. to Report Q2, 2024 Results on Sep 05, 2024

Affimed: AFM24's Update Was Good, Acimtamig's Should Be Better

Affimed N.V. to Report Q1, 2024 Results on Jun 12, 2024

Affimed N.V., Annual General Meeting, Jun 26, 2024

Affimed Announces Positive Early Efficacy and Progression Free Survival Results of AFM24-102 Study in EGFR Wild-Type Non-Small Cell Lung Cancer at the Annual Meeting of the American Society of Clinical Oncology 2024

Affimed N.V. to Report Fiscal Year 2023 Results on Mar 28, 2024

Affimed N.V. Provides Clinical Response Update on AFM24-102 Trial in EGFR-Wildtype Non-Small Cell Lung Cancer

Affimed N.V. Announces CEO Changes

Affimed Announces Updated Phase 1/2 Data from Acimtamig in Combination with Allogeneic Nk in Hodgkin Lymphoma Patients Who Failed Prior Chemotherapy and Are Double-Refractory to Brentuximab Vedotin (Bv) and Checkpoint Inhibitors (Cpis)

Affimed N.V. Announces Executive Changes

Affimed N.V. to Report Q3, 2023 Results on Nov 14, 2023

Affimed N.V. Presents Preclinical Data Showing That Addition of an Innate Cell Engager to Nk and Car-Nk Cells

Affimed N.V. Announces Oral Presentation of Phase 1/2 Data from AFM13 in Combination with Allogeneic NK Cells at the 2023 ASH Annual Meeting

Affimed Announces Listing Transfer to Nasdaq Capital Markets

Affimed Receives FDA Fast Track Designation for AFM13 in Combination with AlloNK(R) for the Treatment of Patients with Relapsed or Refractory Hodgkin Lymphoma

Affimed N.V. Announces Publication in the Journal mAbs on Leveraging FcRn-pH-HPLC as a Method to Select Bispecific Antibodies with Optimal Developability

The Affimed N.V. (NASDAQ:AFMD) Analysts Have Been Trimming Their Sales Forecasts

New major risk - Revenue and earnings growth

Second quarter 2023 earnings: EPS and revenues miss analyst expectations

Consensus revenue estimates fall by 14%

Affimed N.V. to Report Q2, 2023 Results on Aug 10, 2023

Affimed N.V.(NasdaqGM:AFMD) dropped from Russell 2000 Dynamic Index

New minor risk - Market cap size

Affimed Announces Addition of Constanze Ulmer-Eilfort to Its Supervisory Board

Consensus revenue estimates decrease by 22%

Affimed Announces IND Clearance for a Phase 2 Clinical Trial Investigating AFM13 and AB-101 Combination Therapy

First quarter 2023 earnings: EPS and revenues miss analyst expectations

Affimed N.V., Annual General Meeting, Jun 21, 2023

Affimed N.V. to Report Q1, 2023 Results on May 23, 2023

Affimed N.V. Announces Abstracts at Annual Meeting of European Hematology Association

Full year 2022 earnings: Revenues exceed analysts expectations while EPS lags behind

Affimed N.V. Provides Regulatory Update for AFM13

Consensus revenue estimates increase by 28%

Third quarter 2022 earnings: EPS and revenues exceed analyst expectations

Affimed downgraded to hold at Stifel as pipeline lacks development clarity

Health Check: How Prudently Does Affimed (NASDAQ:AFMD) Use Debt?

Now 26% undervalued after recent price drop

Second quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind

Affimed Q2 2022 Earnings Preview

Affimed: Preparing For Key Inflection Points

Does Affimed (NASDAQ:AFMD) Have A Healthy Balance Sheet?

Consensus forecasts updated

First quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind

Affimed Stock: 3 Points For The Bulls

Consensus revenue estimates fall by 23%

Affimed N.V. (NASDAQ:AFMD) Analysts Just Cut Their EPS Forecasts Substantially

Full year 2021 earnings: EPS and revenues exceed analyst expectations

Does Affimed (NASDAQ:AFMD) Have A Healthy Balance Sheet?

Third quarter 2021 earnings released: €0.14 loss per share (vs €0.069 loss in 3Q 2020)

Affimed: Preparing For A Bullish 2022

Second quarter 2021 earnings released: €0.16 loss per share (vs €0.15 loss in 2Q 2020)

Does Affimed (NASDAQ:AFMD) Have A Healthy Balance Sheet?

Consensus EPS estimates increase to -€0.25

Affimed: Current Fall And Future Prospects

First quarter 2021 earnings released: EPS €0.012 (vs €0.11 loss in 1Q 2020)

We Discuss Why Affimed N.V.'s (NASDAQ:AFMD) CEO May Deserve A Higher Pay Packet

Consensus forecasts updated

Need To Know: Analysts Just Made A Substantial Cut To Their Affimed N.V. (NASDAQ:AFMD) Estimates

Revenue & Expenses Breakdown