Actionable news
0
All posts from Actionable news
Actionable news in AFMD: AFFIMED N.V.,

Affimed Reports Financial Results for Third Quarter 2015

HEIDELBERG, Germany, Nov. 10, 2015 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq:AFMD), a clinical-stage biopharmaceutical company developing highly targeted cancer immunotherapies, today reported financial results for the quarter ended September 30, 2015.

"Over this past quarter, we have made progress on several fronts. In terms of pipeline, we are currently enrolling patients in the amended AFM11 study. We also presented data for the first time of our NK- and T-cell engaging TandAbs against a solid tumor target, variant III of the Epidermal Growth Factor Receptor," said Dr. Adi Hoess, CEO of Affimed. "In addition, the recent renewed commitment by a long-term existing shareholder was a validation of our proprietary NK- and T-cell engaging TandAb approach to fight cancer."

Corporate Highlights

  • In October, Affimed raised $21.8 million (¬19.1 million) through the sale of approximately 3.3 million shares to Aeris Capital, a long-term existing shareholder.
  • Based on the proceeds received from the sale, the Company's cash position is expected to fund operations, including clinical development and further discovery and early development activities, at least until the first quarter of 2018.
  • Following acceptance of the Company's proposed protocol amendment by the German Regulatory Agency, the Paul-Ehrlich Institute (PEI), and the participating sites' Ethics Committees, patient enrollment continued into the Phase 1 study of AFM11 in non-Hodgkin lymphoma (NHL) in October. The new protocol allows for investigation of less frequent dosing of AFM11.
  • At the annual Society for Immunotherapy of Cancer (SITC) conference in November, Affimed presented first data on the Company's proprietary T-cell (AFM21) and NK-cell (AFM22) TandAbs, generated against the tumor-specific variant III of the Epidermal Growth Factor Receptor (EGFRvIII). AFM21 and AFM22 showed similar cytotoxic and in vitro potency. The Company anticipates final candidate selection and initiation of IND-enabling studies in the first half of 2016.
  • In November, the Company announced the acceptance of two abstracts as poster presentations on December 6 at the upcoming annual meeting of the American Society of Hematology (ASH) in Orlando, Florida.

Pipeline Updates

AFM13

  • Patient enrollment is ongoing in the Phase 2a clinical trial in Hodgkin lymphoma (HL) for Affimed's lead candidate, AFM13, a bispecific CD30/CD16A NK-cell-engaging TandAb. Interim data are expected in the second quarter of 2016, with full data for the Phase 2a trial remaining on schedule to be reported by the end of 2016.
  • An additional Phase 1b trial in HL with AFM13 in combination with an anti PD1 checkpoint inhibitor is planned to be initiated in the first half of 2016.
  • A Phase 1b/2a investigator-sponsored trial in CD30-positive lymphoma is planned to be initiated in the fourth quarter of 2015.

AFM11

  • For its second pipeline candidate AFM11, a bispecific CD19/CD3 T-cell-engaging TandAb, Affimed continued patient enrollment into an amended Phase 1 clinical trial in patients with NHL. The Company continues to expect initial AFM11 data to become available in the second half of 2016. In addition, Affimed plans to investigate AFM11 in a parallel separate Phase 1 clinical trial in acute lymphocytic leukemia (ALL). The latter is anticipated to be initiated in the first half of 2016.

AFM21, AFM22 and platform

  • Following further in vivo investigation of AFM21 and AFM22, the Company expects to select a candidate toward year-end of 2015 and to commence IND-enabling studies in 2016.

Financial Highlights

(Figures for the third quarter and through September 30, 2015 and 2014 represent unaudited figures.)

Cash and cash equivalents totaled ¬60.4 million on September 30, 2015 (not including ¬19.1 million in proceeds from our October private placement of common shares to long-term existing shareholder Aeris Capital) compared to ¬39.7 million on December 31, 2014. The increase was primarily attributable to Affimed's May 2015 public offering of its common shares, offset by expenses incurred in connection with the Company's...


More