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Affimed N.V. (NASDAQ:AFMD)Q4 2018 Earnings Conference CallMarch 27, 2019, 8:30 a.m. ET
Contents: Prepared Remarks Questions and Answers Call Participants Prepared Remarks:Operator
Good day and welcome to Affimed Full Year 2018 Financial Results and Corporate Update Conference Call. At this time, all participants are in a listen-only mode. As a reminder, today's conference is being recorded. And I will now introduce your host for today's conference, Greg Gin, Head of Investor Relations at Affimed. Please go ahead.
Greg Gin -- Head of Investor Relations
Thank you, operator. Thank you for joining us today for Affimed conference call to discuss the Company's full-year 2018 financial results and operational progress. This morning, Affimed issued a press release, which is posted on the Company's website at www.affimed.com. On the call with me today are Adi Hoess, Chief Executive Officer of Affimed; Leila Alland, Chief Medical Officer; and Florian Fischer, Chief Financial Officer. We will begin today's call with opening remarks from Adi on our progress during the year. Leila will follow Adi and review the key data from our programs that represented at the ASH Annual Meeting. And then Florian will review the financial results.
Following the prepared remarks, we will host the Q&A session. Before we start, let me review our safe harbor statement. Today's discussion contains projections and forward-looking statements regarding future events. These statements represent our beliefs and assumptions only as of the date of this discussion. 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.
These forward-looking statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including but not limited to those identified under the section entitled Risk Factors in our filings with the SEC, and those identified under the form -- the section entitled Cautionary Statement regarding forward-looking statement in our Form 6-K filed with the SEC earlier today.
With that introduction, I will now turn the call over to Adi.
Adi Hoess -- Chief Executive Officer
Thanks, Greg, and good morning, everyone. Thanks a lot for joining us what is the earnings call. Affimed made substantial progress throughout 2018, as we continued to transition our Company from its origin in antibody engineering to an immuno-oncology therapeutics company, committed to advancing our CD16A innate cell agents generated from our fit-for-purpose ROCK platform.
In 2018, we achieved tremendous clinical and cooperate milestones as we continue to focus on actualizing the untapped potential of the innate immune system to give back patients their innate ability to fight cancer.
Our clinical progress is highlighted by multiple data presentations at the 60th ASH Annual Meeting that supports the substantial opportunity for AFM13 as both monotherapy and combination therapy in CD30-positive tumors. In a few moments, Leila will provide a summary of our key data that represented at ASH. Leila will also review the US registrational pathway and update the clinical development plan for AFM13 that we announced at our R&D Day in December.
Our corporate progress is highlighted by the strategic collaboration that we entered into with Genentech in August 2018 for NK cell engager-based immunotherapeutics generated from our CD16A targeting ROCK platform. This partnership is a transformational accomplishment for Affimed, and has the potential to accelerate the understanding of the role of innate immune cell engagement and activation within an immuno-oncology.
We plan to leverage the respective strengths of Affimed and Genentech to advance the development of CD16A targeting innate cell engagers with the goal of achieving durable benefit for patients with cancer. We've recently announced that we will receive a payment and an undisclosed amount triggered by the achievement of a pre-clinical milestone under this collaboration. The funding that we've received to-date from the Genentech collaboration provides an important source of non-diluted financing for Affimed, supporting further development of our own pipeline.
A coming question that we hear from investors in industry is, what does Affimed bring to Genentech? We believe this partnership shows that the value of our ROCK platform -- shows the value of our ROCK platform, as well as our expertise in developing by specific antibodies in unique formats, and activating innate immunity with our CD16A targeting approach to eliminate cancer cells. Our ROCK platform enables us to pursue clinically validated tumor antigens, for which current therapies have shown limited efficacy, and or dose limiting toxicities. We believe this is a key strategic differentiator with our innate cell engager approach that Affimed can bring to Genentech in order to help address certain targets that they could not pursue with their existing technologies. This is indeed the same strategy that we're pursuing for AFM -- with AFM24 our second innate cell engager, and a potential treatment for multiple solid tumor malignancies. I will talk more about AFM24 later in the call. In short, we believe our clinical incorporate progress further demonstrates our expertise in innate immunity and the potential for therapeutics based on our novel CD16A-targeting innate cell engager approach to treat cancer.
Before I turn the call over to Leila, let me briefly comment on our focus moving forward. Looking ahead to the balance of 2019, our efforts are aimed as continuing to advance our development programs and achieving additional milestones with our collaboration partners, including moving our lead development candidate AFM13 into a market registration directive monotherapy study, reporting clinical data updates from the ongoing monotherapy study and completed combination study with Keytruda, and entering the clinic with AFM24.
Now, I will hand it over to Leila to review the ASH data, and outline our development plan for you AFM13. Leila?
Leila Alland -- Chief Medical Officer
Thank you very much, Adi. Before I review the key AFM13 data at ASH, I would like to start with an update on progress with AFM11, our CD19 targeting by specific T cell engager. AFM11 was being studied in two Phase 1 clinical studies for the treatment of patients with relapsed or refractory CD19 positive T cell non-Hodgkin lymphoma, and relapsed or refractory acute lymphoblastic leukemia, respectively. As you may recall, AFM11 is on clinical hold after the occurrence of life threatening serious adverse events in three patients. As presented at the 2018 ASH Annual Meeting, AFM11 showed three complete remissions at dose levels of four, five and six in ALL patients. And overall, the safety profile of AFM11 appeared favorable in the ALL study.
We have worked closely with investigators to review all of the safety findings in detail. After having assessed all of the data from the AFM11 program, we recently submitted our response to the U.S. Food and Drug Administration, with a request that the clinical hold be lifted and that clinical development of AFM11 may proceed in patients with ALL. I would like to take a moment to thank the Affimed team who worked hard to enable us to submit an extremely thorough response to the FDA that summarizes the clinical data from the two Phase 1 studies of AFM11 in detail.
Now, let's move on to AFM13. In December, we and our academic collaborators presented clinical data at the 2018 ASH Annual Meeting, supporting the potential of AFM13 as monotherapy, and in combination with a checkpoint inhibitor and cord blood-derived allogeneic NK cells respectively. The data at ASH increased our confidence that AFM13 holds significant therapeutic value for patients with CD30-positive lymphomas.
Dr. Ahmed Sawas of Columbia University and the principal investigator of the Phase 1b/2a a trial of AFM13 in CD30-posit
