$AFMD AFM13 pivotal mid-Dec, cbNK combo data at #ASH22 key near-term
catalysts.
With multiple ongoing trials, and declaration of a partnership with an NK cell company that
has established cGMP manufacturing capabilities, we believe AFMD is set up for a catalyst
rich 6-12 months ahead. Key Inflection Points before year-end: 1) AFM13/cbNK MDACC
data update at ASH; 2) AFM13 r/r PTCL pivotal data mid-December. We also expect data
updates from ongoing AFM24 trials across all cohorts in 2023. We have updated our model
for 3Q2022 results. Reiterate Buy.
Upcoming Catalysts –
• AFM13 pivotal data mid-Dec
• AFM13/cbNK in r/r CD30+ lymphomas - oral update @ ASH and Investor event on
December 10th
• FDA feedback on AFM13/AB-101 combo in 1Q2023
• IND filing for AFM13/AB101 combo in 1H2023
• Data updates from AFM24 monotherapy and combo cohorts at major medical
conferences likely in 2Q2023/3Q2023.
Multiple data sets expected from AFM13 trials in 4Q2022; company investor event on
December 10th.
• Topline data from REDIRECT mid-December; enrollment completed earlier in 2022.
Focus will be on ORR as assessed by BICR (primary endpoint) and preliminary analysis
of DOR and safety.
• Plan for r/r PTCL based on REDIRECT study – company plans to consult with FDA once
they have data and the discussion will also include a registration study. Co. acknowledged
challenges recently for peer companies around accelerated approvals.
• Will also see update from AFM13/cbNK combo data from r/r HL from the MDACC PI
(December 10th). These are pre-complexed with AFM13 (single infusion) followed by 3
AFM13 infusions. 24 pts treated with RP2D (11 more pts vs. AACR) showed 100% ORR
and CR increased to 70.8%.
• As a reminder, we apply 85% probability to $420M US opportunity in R/R PTCL; 70%
probability to $150M US opportunity in 3L HL
Company highlighted partnership with Artiva (Private) and their cord blood derived
NK cell product; FDA feedback expected 1Q2023 and IND submission planned for
1H2023.
• Management reiterated that AB101 is an active NK cell product and synergy seen with
AFM13. Please see our note on the partnership HERE.
• Confident that AFM13 + AB101 combo has the potential to generate robust ADCC
response.

• Factors that led to partnership –
○ 1) AB101 is already in clinic with cleared IND and is a cryo-preserved OTS product.
○ 2) Consistent and high CD16 expression.
○ 3) cGMP facility and viable cost structure.
• Requested pre-IND meeting with the FDA. Goal is to submit IND in 1H2023 and initiate a pivotal trial later in the year. Mgmt expects
rapid enrollment based on data package for each product, clinical POC of AFM13/cbNK (MDACC), and exceptional safety profile.
• Artiva's NK cells have been vetted – AFMD have intensely looked at the cells and what they have worked with Artiva,
○ Artiva does pre-activate with cytokine. Protocol is slightly different from MDACC. There is no meaningful differences between
the cells.
○ Uniform and bright CD16A expression is present and the primary variable to consider. Mgmt guided they've tested almost all NK
cell sources (PB, CB, iPSC) and CD16A expression was the one key denominator.
○ As long as NK cells express CD16, they see that AFM13 synergizes. AB101 – similar to product that they want to commercialize.
When they look in the CD16+ cells, and directly compare co-administration and pre-complexed, cytotoxicity is comparable.
• Bridging therapy is being considered as are all other scenarios/solutions. Company believes dose escalation is less challenging with
non-modified cells. They may need to treat in a staggered manner.
AFM24 programs continue to enroll patients in all 3 cohorts; data updates likely at major medical conferences in 2Q and 3Q
• Continuing to enroll pts in all three cohorts – monotherapy, PD-L1 combo, and NK cell combo.
• Monotherapy expansion includes RCC, NSCLC with activating EGFR mutations, and KRAS WT CRC. Combo studies are still in dose
escalation phases to evaluate safety and establish RP2D.
• PD-L1 combo expansion at 480mg dose. 3 pts have completed DLT assessment and 3 additional to be enrolled to confirm 480mg
as the RP2D.
○ Recall updated data detailed in our SITC note: SITC 2022 Nuggets #2: TGFbeta, NK engagers, and TIGIT
• NK cell combo – both agents are given weekly to pts with NSCLC, HNSCC, and CRC.
• Single patient treated with PD-1. PD-1 re-challenge response was very unlikely in this pt based on previous clinical experience.
• 2nd patient – PDAC, progression on prior therapies.
• AFMD will submit abstracts for all 3 programs in 2023. We're likely to see an update.
• EGFR expression in the gastric pt's skin mets was present (SITC). Mgmt guides there is no evidence that EGFR is upregulated
when tumors metastasize.
○ Mgmt believes AFM24 is active at all tumor sites (primary and distal).
○ They did a specific and detailed analysis of a number of tumor histologies which led to the determination of which combos are
best suited for the indications they are moving forward with.

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