On November 19, 2019 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company committed to giving patients back their innate ability to fight cancer, reported financial results for the quarter ended September 30, 2019 and provided an update on clinical and corporate developments (Press release, Affimed, NOV 19, 2019, View Source [SID1234551478]).

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"We are excited to commence patient dosing in our Phase 2 study of AFM13 in support of registration, bringing us one step closer to delivering a potential new treatment for pTCL patients, who have very few treatment options," said Dr. Adi Hoess, Affimed’s CEO. "In addition, the IND for the first ever clinical trial bringing together an innate cell engager (AFM13) and adoptive NK cell transfer has cleared. This study of AFM13 and MD Anderson’s NK cell product could address a much broader group of patients with CD30-expressing lymphomas, including Hodgkin lymphoma, cutaneous T-cell lymphoma and diffuse large B-cell lymphoma."

Program Updates
AFM13 (CD30/CD16A)

In November 2019, the first patient was dosed in a Phase 2 registration-directed study of AFM13 as monotherapy in relapsed or refractory patients with CD30-positive peripheral T cell lymphoma (pTCL). The results of the study, if positive, could form the basis for a Biologics License Application submission and support an accelerated approval given the unmet medical need for safe and effective new treatments in this hard-to-treat patient population. The study will also enroll a cohort of patients with transformed mycosis fungoides, an aggressive subtype of cutaneous T cell lymphoma.
The U.S. Food and Drug Administration (FDA) cleared an investigational new drug application (IND) for an investigator-sponsored Phase 1 study, in which the University of Texas MD Anderson Cancer Center (MDACC) plans to investigate the combination of AFM13 with allogeneic NK cells. MDACC intends to administer a stable complex of AFM13 pre-mixed with cord blood-derived allogeneic NK cells in different doses (numbers of pre-loaded NK cells) to patients with relapsed/refractory CD30-positive lymphoid malignancies. The combination represents a novel approach to further improve response rates and durability of responses in this patient population.
AFM24 (EGFR/CD16A)

In October 2019, Affimed received clearance of its IND for AFM24 from the FDA, enabling the company to proceed with its planned Phase 1/2a clinical study of the tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding innate cell engager in patients with advanced cancers known to express EGFR. The clearance of the IND follows the company’s IND submission in late-September 2019. Affimed expects the study, which is aimed at establishing safety and identifying initial signals of efficacy of AFM24, to initiate in the first quarter of 2020.
Pipeline Updates
Affimed selected two new CD16A-binding innate cell engager candidates (AFM28 and AFM32) from our ROCK platform for undisclosed targets that the company plans to advance into preclinical studies in 2020 with the aim of supporting future IND submissions. The selection of the new development candidates follows Affimed’s evaluation of innate immune cell activity versus a number of potential targets that are expressed in multiple hematological and solid tumor malignancies.
Genentech Collaboration
In November 2019, Genentech exercised its final option for an exclusive target under the ongoing, multi-program strategic oncology collaboration agreement to develop and commercialize novel NK cell engager-based immunotherapeutics generated from Affimed’s ROCK platform to treat multiple cancers. The target selection triggers a payment in an undisclosed amount to Affimed from Genentech.
Management Changes
Affimed announced the appointment of Cassandra Choe-Juliak, MD, MS as Acting Chief Medical Officer to succeed Dr. Leila Alland, effective November 30, 2019. Dr. Alland will transition out of her current role and will serve as a consultant for the company. Dr. Choe-Juliak has over 13 years of experience in drug development and medical affairs in immuno-oncology/oncology for both hematological and solid tumor malignancies. Since joining Affimed in July 2017, she has served as the clinical leader for the AFM13 development program.
Dr. Hoess commented, "Cassandra’s deep expertise in drug development and strong leadership skills have been, and will continue to be, a tremendous asset to Affimed and our clinical team as we advance our pipeline of innate cell engagers. I would also like to thank Leila for her many contributions to Affimed and wish her success in her future endeavors."

Financial Highlights
(Figures for the third quarter and nine months ended September 30, 2019 and 2018 are unaudited.)
Cash, cash equivalents and current financial assets totaled €76.5 million as of September 30, 2019, compared to €108.8 million as of December 31, 2018. In November 2019, Affimed completed a public equity offering with net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses, of approximately $32 million (€29 million). Based on its current operating and budget assumptions, the company anticipates that its cash, cash equivalents and current financial assets as of September 30, 2019, together with the proceeds from the stock offering, will enable the Company to fund its planned clinical development and early development activities at least into the fourth quarter of 2021.

Net cash used in operating activities was €30.6 million for the nine months ended September 30, 2019, compared to net cash used in operating activities of €24.9 million for the nine months ended September 30, 2018. The increase is primarily due to higher cash expenditure for research and development efforts.

Total revenue was €2.1 million for the three months ended September 30, 2019 compared to €0.3 million for the three months ended September 30, 2018. The increase in revenue is attributable to the recognition of €1.9 million as revenue from the Genentech collaboration in the third quarter of 2019.

Research and development (R&D) expenses for the third quarter of 2019 were €11.7 million, compared to R&D expenses for the third quarter of 2018 of €9.8 million. The increase was primarily related to higher expenses related to manufacturing activities for clinical study material for AFM13, startup activities for the AFM13 registration study in pTCL and early stage development and discovery activities.

General and administrative expenses for the third quarter of 2019 were €2.8 million compared to €2.4 million for the third quarter of 2018.

Net loss was €10.9 million, or €0.17 per common share, for the third quarter of 2019, compared to a net loss of €12.0 million, or €0.19 per common share, for the third quarter of 2018.

Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports the consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information
Affimed will host a conference call and webcast today, Tuesday, November 19, 2019 at 8:30 a.m. Eastern time to discuss the company’s financial results and recent corporate developments. To access the call, please dial +1 (631) 510-7495 for U.S. callers, or +44 (0) 2071 928000 for international callers, and reference conference ID 8758067 approximately 15 minutes prior to the call. An audio webcast of the conference call can be accessed in the "Webcasts" section on the "Investors" page of the Affimed website at View Source A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived for 30 days following the call.