affimed presentation june 2015
TRANSCRIPT
Corporate Presentation June 2015
Breakthrough Cancer Therapies: Directing the Immune System to Eliminate Tumor Cells
Forward-looking statements / safe harbor
This presentation and the accompanying oral commentary contain “forward-looking” statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation and the accompanying oral commentary, including statements regarding our future financial condition, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “believe,” “will,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “might,” “approximately,” “expect,” “predict,” “could,” “potentially” or the negative of these terms or other similar expressions. Forward-looking statements appear in a number of places throughout this presentation and the accompanying oral commentary and include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates AFM13, AFM11 and AFM21, our intellectual property position, our ability to develop commercial functions, expectations regarding 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 and the risks uncertainties and other factors described under the leading “Risk Factors” in Affimed’s filings with the Securities and Exchange Commission.
Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.
Forward-looking statements represent our management’s beliefs and assumptions only as of the date of this presentation. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.
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Corporate facts Nasdaq: AFMD
• Affimed is developing immune cell engagers in immuno-oncology
• Leading edge technology platforms that
• Direct the immune system to eliminate tumor cells
• Target NK-cells or T-cells
• Clinical stage product candidates are unencumbered
• Leader in NK-cell-based approach
• Validation through partnerships with Amphivena/Janssen (JnJ) and support from The Leukemia & Lymphoma Society (LLS)
• Raised $97 million in IPO on Nasdaq and follow-on
• Cash and cash equivalents as of March 31, 2015: EUR 37.0 million (not including EUR ~33.2 million net proceeds from May 2015 follow-on)
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Current pipeline and programs Global rights retained with 3 candidates
Worldwide rights with Affimed Partnered program
Compound Disease Target Immune Cell Target Indication Discovery Preclinical Phase 1 Phase 2 Phase 3
AFM13 CD30 CD16A / NK-cell
Hodgkin Lymphoma
CD30+ Lymphoma
Hodgkin Lymphoma Combination with CPIs*
Hodgkin Lymphoma Combination with Lenalidomide
AFM11 CD19 CD3 / T-cell Non-Hodgkin Lymphoma
Acute Lymphocytic Leukemia
AFM21 EGFRvIII CD3/T-cell CD16A/NK-cell
Solid Tumors
TandAb CD33 CD3 / T-cell Acute Myeloid Leukemia
Trispecific Abs Undisclosed undisclosed Multiple Myeloma
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*CPI = Checkpoint inhibitor
Highlights H1-15
• Raised $41 million in follow-on offering in May 2015 to enhance AFM13 and AFM11 programs and to generate further NK-cell engagers
• Performed pre-clinical studies of AFM13 in combination with checkpoint inhibitors (Stanford) and lenalidomide (Mayo Clinic); combination data were presented at ASCO 2015
• Selected CD33/CD3 candidate for IND-enabling studies in collaboration with Amphivena/Janssen; received milestone; presented 3 posters at ASCO
• Published three papers: AFM13 phase 1 (BLOOD), AFM11 preclinical data (mAbs) and TandAb generation (Eur. Pharm. Rev.)
• Received BMBF grant to support dual tumor targeting platform and development of multi-specific antibodies for multiple myeloma
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Credit: Joshua Stokes, St. Jude Children's Research
Hospital
Engaging NK-cells to Fight Cancer:
AFM13
NK-cells: Important cells for innate immunity Significant interest by industry
KIR2
NKG2a
CD16A (FcgRIIIA)
IPH2201 Innate/AZ
Lirilumab Innate/BMS
TNFa
IFNg
CD137 (4-1BB)
PD-1 GITR
CD319 (CS1)
Elotuzumab BMS/Abbvie
Nivolumab Pembrolizumab
BMS, Merck
Urelumab PF-05082566 BMS, Pfizer
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AFM13 CD16A TandAbs Affimed
Other cytokines
PD-L1 MEDI4736
MPDL3280A MSB0010718C
AZ, Roche MerckSerono/Pfizer
MK-4166 Merck
IgGs
TandAbs
Stimulation of T-cell response
NK-cell engagement: Targeted single cell apoptosis induction via immune cell engagement
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NK-cell with CD16A receptors and tumor cell with CD30 receptors
NK-cell TandAb locks NK-cell and tumor cell in close proximity and activates NK-cell
NK-cell releases per- forin, creating pores in tumor cell membrane through which granzyme enters, triggering caspase cascade
Granzyme and caspase action trigger apoptosis of tumor cell
Stage 1 Stage 2 Stage 3 Stage 4
AFM13
• Clinically most advanced NK-cell engager validating platform
• Potential as drug in CD30-positive lymphoma
• Demonstrated clinical and PD activity in heavily pretreated HL patients
• Data were published in Blood and ASH2014
• Phase 2a initiated in r/r HL patients
• Maximize effect by optimized regimen and longer treatment period
• Very good safety, well suited for combination with wide range of other drugs
• CPIs and lenalidomide in preclinical investigations (Stanford University and Mayo Clinic)
• Study role of NK-cells in tumor environment
• NK-cells may influence T-cell tumor infiltration
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AFM13: Significant synergy of AFM13 in combination with PD-1 inhibitor
• Tumor pieces (8x8 mm) were derived from surgical specimens of a newly diagnosed CD30+ Hodgkin Lymphoma patients; Tumor pieces (8x8 mm) were xenografted and mice were randomized into 8 groups on day 28.
• Autologous PBMCs were infused on day 28 (2x106 PBMCs/mouse) i.p.
• Therapy with AFM13 and CPI began on day 28 and continued weekly for a total of three I.P injections.
• Tumor size was compared between groups on day 58.
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AFM13: Increased number of tumor-infiltrating cytotoxic T-cells with AFM13/PD-1 and ./CTLA-4
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AFM13 Clinical development strategy
Phase 2, PoC
r/r HL
GHSG; n=40
Phase 1b/2a, TR
CD30+ lymphoma
Columbia; n=24
Phase 1b, + CPI
r/r HL
n=t.b.d.
Data on
PoC
Data on
dose
Data on
combo
End of Ph2
Meeting FDA
Registration
Study
Study initiated
Studies in planning
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• Encouraging phase 1 data
• Clinical strategy to validate AFM13 and NK-cell platform
• The Leukemia & Lymphoma Society provides major financial contribution
• Opportunity for mono- and combination therapies
• Multiple near-term milestones
• Broadening of NK-cell engager pipeline in NHL, colon/H&N, MM or GBM
AFM13 Summary
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Funded activities
Planned milestones, news releases,
posters/ presentations
Ph2a HL Monotherapy
Ph1b/2a CD30+ lymph.
ASH ASH ASCO ASCO ASCO
Preclin. AFM13+CPI
Preclin. AFM13+Len.
Ph1b HL AFM13+CPI
AFM13
2015 2016 2017
Follow-on
Manufacturing
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© STEVE GSCHMEISSNER/SCIENCE SOURCE
Engaging T-cells to Fight Cancer:
AFM11
AFM11 Differentiation from BiTE
• Blincyto (blinatumomab) is first T-cell engager approved by FDA for treatment of ALL (12/14)
• AFM11 (CD19/CD3 TandAb) preclinical data (published in mAbs)
• ~100-fold higher affinity to CD3 as compared to BiTE
• Low pM cytotoxicity maintained at low effector to target (E:T) ratio
• Prolonged t½ allows regular i.v. infusion
• Phase 1 dose escalation in NHL/ALL patients ongoing
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Blincyto AFM11
MW ~55 kDa ~104 kDa
Binding sites 1 for each, CD3 & CD19 2 for each, CD3 & CD19
Affinity to CD3+ cells 100 nM 1 nM
AFM11 Clinical development strategy
Phase 1, Safety r/r NHL/ALL
AFMD; n=30-36
Phase 1, Safety NHL (new regimen)
AFMD; n=t.b.d.
Phase 1, Safety ALL (new regimen)
AFMD; n=t.b.d.
Data
Data
Data
Scientific Advice
Meeting FDA/EMA
POC studies in NHL and/or ALL
Study initiated
Studies in planning
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AFM11 Summary
• Phase 1 dose escalation in NHL/ALL patients initiated
• Endpoints: safety, activity, efficacy
• Drug administered by regular i.v. infusion
• Multiple options for differentiation from competition
• Indication, convenience (“CAR-T in a vial”)
• Multiple near term milestones
• Strong market potential
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AFM11 Ph1 NHL/ALL
2015 2016 2017
ASH ASH ASCO ASCO ASCO
Ph1 ALL (new dose regimen)
Ph1 NHL (new dose regimen)
Funded activities
Planned milestones, news releases,
posters/ presentations
Follow-on
AFM21 Summary of preclinical program
• EGFRvIII is a highly tumor-specific receptor variant
• EGFRvIII is expressed e.g. in glioma/glioblastoma, prostate, H&N, breast, lung
• Data update at AACR 2015 (poster presentation)
• 2 molecules at discovery stage
• EGFRvIII/CD3 TandAb
• TandAb candidates are potent and show efficacy in animal tumors model
• EGFRvIII/CD16A TandAb
• Molecule generation has been advanced
• Milestone and news flow
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2015 2016 2017
ASH ASH AACR ASCO ASCO
Preclinical Development AFM21 (T- or NK-cell) Planned milestones,
news releases, posters/ presentations
Partnership with Amphivena/Janssen Achieved milestone ahead of schedule
• Development of a CD33/CD3 TandAb for AML
• Program further validates robustness of Affimed’s TandAb platform
• Rapid identification of preclinical candidate (< 18 months)
• Molecules are stable, highly expressed, and display significant in vitro and in vivo cytotoxicity
• 2nd milestone achieved in March 2015 triggering payment of EUR 7.5 million
• Corroborative evidence of direct correlation between binding affinity and potency
• Confirmed in translational studies (primary AML specimens)
• To be presented at ASCO (3 posters – Abstracts 3057, 7067 & 7071)
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2013 2014 2015
ASH ASH ASCO ASCO ASCO
Preclinical Development Amphivena/Janssen
2016
Planned milestones, news releases,
posters/ presentations
Platform development Trispecific Abs
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• Based on tetravalent platform
• Results in high affinity and, importantly, in increased selectivity for malignant tissues compared to healthy tissues
• Platform offers an expansion of target space
• Program for the therapy of multiple myeloma initiated
• Supported by EUR 2.4 million ($3 million) German government research grant
Tumor cell
Cytotoxic
effector cell
CD19 CD30
Healthy cell Healthy cell
Use of proceeds and milestones Strong news flow in 2015 and 2016
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Ph2a HL Monotherapy
Ph1b/2a CD30+ lymph.
AFM13
AFM11 Ph1 NHL/ALL
Novel NK-cell engagers
2015 2016 2017
ASH ASH ASCO ASCO ASCO
Preclinical Development
IPO
Funded activities
Planned milestones, new
releases, posters/ presentations
AFM21 (T- or NK-cell)
Preclin. AFM13+CPI
Preclin. AFM13+Len.
Preclinical Development Janssen/Amphivena
Trispecific Program
Discovery/ Preclin. Development
Ph1b HL AFM13+CPI
Ph1 ALL (new dose regimen)
Ph1 NHL (new dose regimen)
Follow-on
Manufacturing
Q1/2015 Cash flow statement
• Net proceeds of May 2015 follow-on ~33,166
• Cash reach projected through H2/2017 (including this financing and additional use of proceeds of this financing)
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in thousands of € For the three months ended March 31, 2015
Cash and Cash equivalents at the beginning of the period 39,725
FX related changes to Cash and Cash equivalents 1,269
Net cash used in operating activities (3,924)
Cash Flow from investing activities (37)
Cash Flow from financing activities 0
Cash and Cash equivalents as of March 31, 2015 37,033
Our strategy Maximize value from pipeline and technologies
• Leverage first product to establish market in key indication
• Develop AFM13 through approval in salvage settings in multiple CD30-positive indications and detail product through own U.S. and/or EU sales forces
• Salvage settings enable fast development path and cost-efficient M&S structure
• Scientific leadership in NK-cell engagement
• Position AFM13 as combination drug with CPIs and other anti-cancer agents
• Use pipeline and technologies to create value through both next-generation products and deal opportunities
• Develop AFM11 through phase 2 POC studies
• Advance EGFRvIII TandAbs (AFM21) in solid tumors
• Enhance CD16A/NK-cell TandAb pipeline
• Add high-value technology platform partnership
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