Affirmed, Data Due in December, Potential Catalysts, Clinical Highlights

Affimed N.V. (Nasdaq: AFMD) engineers targeted immunotherapies, seeking to cure patients by harnessing the power of innate and adaptive immunity (NK and T cells). It is developing single and combination therapies to treat cancers and other life-threatening diseases.

On November 7th, the company announced results for the quarter ended September 30, 2017, and provided an update on its present pipeline. AFMD continues to make great strides in validating its NK cell engager programs, in particular through encouraging data from studies of its lead candidate AFM13, which is progressing through clinical development as a mono-and combination therapy.

Leveraging its unique NK cell-based platform for high-affinity CD16A-targeting, the company is advancing its tetravalent bispecific antibodies with the potential to tailor immune-engaging therapy to different indications and settings.


Near-to medium-term catalyst includes: AFMD is scheduled to present clinical and preclinical data on its immune cell engagers AFM13 and AFM26 at the 59th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 9-12, 2017 in Atlanta, Georgia.


AFMD continues to be an industry leader in NK-cell engagement, and its lead product candidate AFM13 is one of the most advanced NK-cell engager in clinical development. The company is particularly interested in unlocking the full potential of NK-cells immunoncology through suitable combination approaches.

On the one hand the company is aiming to generate a conservative immune response through combinations of synergistic mechanisms for instance by combining its products with checkpoint inhibitors or cytokine. On the other hand, it can increase the number and activity of NK-cells available for an immune response via adoptive transfer. To this end, it formed several collaborations with industry and academia.

The company also has a well-differentiated seasonal based approach which includes its own clinical candidate AFM11, and it will provide an all its clinical programs as well as its preclinical programs to date.

The upcoming presentations results/developments are likely to be the near-term catalysts for the stock. The stock currently has an average rating of “BUY” and a consensus price target of $6.50. Considering present valuation, AFMD is at a favorable risk-reward position.


About the company: Affimed N.V. (Nasdaq: AFMD), a clinical-stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies.



NK cell engager programs:

  • In Affimed’s Phase 1b combination study of its lead product candidate, the CD30/CD16Atargeting NK cell engager AFM13, with Merck’s Keytruda (pembrolizumab) in Hodgkin lymphoma (HL) the dose expansion cohort is open and recruiting. The Company intends to present detailed dose escalation data including response data of the three remaining patients in cohort three at the upcoming ASH 2017 Annual Meeting in December.
  • Affimed is supporting a translational Phase 1b/2a study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation led by Columbia University.
  • The Company has developed multiple tetravalent, bispecific antibody formats in addition to its TandAbs. These molecules confer distinct biophysical properties aimed at tailoring PK profiles.
  • Affimed is currently evaluating its novel format-based AFM24 molecules, which have significantly longer half-lives, in comparison to the Company’s TandAbs, which have already shown evidence of a beneficial safety profile.


T cell engager programs

  • Affimed is conducting two clinical Phase 1 dose-escalation trials with AFM11, a CD3/CD19- targeting tetravalent bispecific T cell engager in patients with relapsed and refractory (r/r) acute lymphocytic leukemia (ALL) and with r/r non-Hodgkin lymphoma (NHL), respectively. Both studies are ongoing and recruiting.
  • Recruitment is ongoing into a first-in-human Phase 1 dose escalation trial of AMV564 conducted by Amphivena Therapeutics, Inc. in patients with r/r acute myeloid leukemia (AML). AMV564 is a CD33/CD3-specific antibody based on Affimed’s technology platform. Affimed owns ~18.5% of Amphivena (fully diluted).


Third Quarter Financial Results 

Cash and cash equivalents and financial assets totaled €41.8 million as of September 30, 2017, compared to €44.9 million as of December 31, 2016.

Revenue for the third quarter of 2017 was €0.5 million compared to €0.9 million for the third quarter of 2016. Revenue in the 2017 period was derived from AbCheck services while revenue in the 2016 period related predominantly to Affimed’s collaboration with Amphivena.

Net loss for the third quarter of 2017 was €8.1 million, or €0.18 per common share, compared to a net loss of €10.3 million, or €0.31 per common share, for the third quarter of 2016. The decrease of operating expenses was partially offset by lower revenue and higher finance costs.


Key risk factors and potential stock drivers:

The favorable outcome of the upcoming catalysts (as mentioned above) is expected to provide a boost to the stock to retain its momentum. Any adversities related with the same could upset the stock performance significantly.

AFMD presently has net level losses. Therefore, any crunch in its liquidity and financial flexibility will further impact its business & financial profile.

The company’s near-term stock movement is also dependent on its upcoming quarterly result, any significant adversities/lower than expected guidance could adversely affect the investor sentiments.

Biotech space in itself is a high-risk sector due to uncertainties associated with the novel drug development. Therefore, favorable outcome of the upcoming catalyst is necessary for the stock to retain its momentum. Any adversities related to the same could impinge the stock performance significantly.


Stock Chart:


  • On Monday, November 27th, 2017, AFMD was at $2.00 (down by -4.76%) on volume of 115K shares exchanging hands. Market capitalization is $91.46 million. The current RSI is 47.09
  • In the past 52 weeks, shares of AFMD have traded as low as $1.65 and as high as $2.95
  • At $2.00, shares of AFMD are trading below its 50-day moving average (MA) at $2.11 and below its 200-day moving average (MA) at $2.20.
  • The present support and resistance levels for the stock are at $2.00 & $2.20 respectively.


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