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Healthcare - Biotechnology - NASDAQ - DE
$ 3.48
-4.66 %
$ 53 M
Market Cap
-0.63
P/E
EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2018 - Q2
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Executives

Greg Gin - Head of Investor Relations Adi Hoess - Chief Executive Officer Florian Fischer - Chief Financial Officer.

Operator

Good day, and welcome to Affimed Second Quarter 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. I’ll now introduce your host for today’s conference Greg Gin, Head of Investor Relations at Affimed. Please go ahead..

Greg Gin

Thank you, operator. And thank you for joining us today for Affimed conference call to discuss the Company’s second quarter 2018 financial results and operational progress. This morning, Affimed issued a press release, which is posted on the Company’s Web site at www.affimed.com.

On the call with me today are Adi Hoess, CEO of Affimed and Florian Fischer, Affimed’s Chief Financial Officer. The agenda for today’s call is as follows; Adi will make brief opening remarks and provide an update on the Company’s second quarter 2018 and recent development; and then Florian will walk you through the financials.

As mentioned in this morning press release, we plan to report new data at a scientific or medical conference and share updates on estimate pipeline programs with you in the fourth quarter of 2018. So as a result, we will not be conducting a Q&A session on the call today.

Before we start, please note that during this call, the Company will make 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 section titled, Cautionary Statement Regarding Forward-Looking Statements in our Form 6-K filed with the SEC earlier today.

And with that, I will now turn the call over to Affimed’s CEO, Adi Hoess.

Adi?.

Adi Hoess

Thanks, Greg and good morning, everyone. And thank you for joining us today. During the second quarter, we continued to make progress with all of our pipeline programs according to our internal plan.

Importantly, for our most advanced program AFM13, clinical development is on track and we plan to report additional results from the combination study of AFM13 and Merck’s Keytruda in the fourth quarter of 2018. At the same time, we are in ongoing discussions with clinical and regulatory experts to define the future development paths.

In addition, we’re deepening our understanding of the cellular and molecular mechanisms underlying our engagers' activation of innate immune cells for tumor cell kill.

This is an important advancement and the expansion of our pipeline as we explore suitable combinations with our engagers, such as with checkpoint inhibitors, adoptive NK cell transfer or cytokines, in order to explore the potential of achieving more health and durable anti tumor efficacy.

I am going to focus my comments this morning on the pipeline progress in the second quarter, starting with our NK cell engager programs. In June, we record updated interim data from our Phase 1b combination study of AFM13 with KEYTRUDA or pembrolizumab in patients with relapse refractory Hodgkin Lymphoma at the EHA Congress in Stockholm.

This combination of AFM13 and pembrolizumab was well tolerated and showed encouraging response rates versus pembrolizumab monotherapy.

As a reminder, AFM13 is our biospecific antibody designed to recognize CD30 and engage innate immune cell, such as natural killer cells or NK cells and microphages via the CD16A receptor inside the body to attack CD30 expressing cancer cells. Let me briefly elaborate on the mode of action of our biospecific antibodies.

During the early stage of tumor regenesis innate immune cells play a crucial role in recognizing and eliminating tumor cells. However, cancer cells avoid recognition but in the immune cells hence evading immune cell and outgrowing the body. Our CD16A immune cell engagers reestablish that recognition leading to killing off the targeted tumor cells.

In this context, we believe that in addition to Hodgkin Lymphoma, AFM13 has potential for a broader utility across other CD30 expressing hematological cancer. I’d like to remind you that AFM13 as monotherapy has shown stimulations activity in an ongoing HL study and in an ongoing study in patients with CD30 positive T-cell Lymphoma.

The lateral is an investigator sponsored translational Phase 1b/2a study of AFM13 in patients with relapse or refractory CD30 positive lymphoma, with cutaneous manifestation and is being led by Columbia University. Recruitment has been completed into this study.

Looking ahead, we and investigators at Columbia intend to provide updated data on AFM13 at combination and monotherapy at a scientific medical conference in the fourth quarter of 2018.

Based on the promising AFM13 data that has been generated to-date, we are currently evaluating future clinical development plans for AFM13, and continues to have discussions with clinical and the regulatory experts to help inform our strategy.

In addition, we intend to initiate discussions with the FDA on potential expedited development path for AFM13. Let’s turn briefly to our preclinical NK cell engager program, AFM24 and AFM26. AFM24 is an NK-cell engager that targets CD16A on NK cell and EGF receptor on solid tumor cells.

AFM24 is designed to address toxicity of and efficacy issue with anti-EGFR monoclonal antibodies and to allow for more convenient dosing.

We believe AFM24 has the potential for better efficacy and safety as compared to current therapeutic anti-EGFR monoclonal antibodies Affimed presented data from its AFM24 program at the American Association for Cancer Research in Chicago, in April. We anticipate completing IND enabling studies for ASM24 by mid-2019.

Our AFM26 preclinical program directs NK cell anti-tumor activity towards tumor cell expressing BCMA. This BCMA targeting NK cell engager is designed to address the medical need of eliminating minimal residual disease in patients with multiple myeloma.

Affimed is progressing for preclinical development towards IND enabling studies, and we intend to provide an update on this program at a scientific medical conference in the fourth quarter of 2018.

As we look to expand our NK cell engager leadership position, we and development partners are exploring future opportunities for our NK cell engager platform. For example, we are exploring a combination of AFM13 with adoptive NK cell transfer in preclinical models to enhance efficacy in a collaboration with the MD Anderson Cancer Center.

In these experiments, MD Anderson is investigating an allogeneic NK cell product, which is cord blood derived. MD Anderson and Affimed plan to report data on the combination at a scientific or medical conference in the fourth quarter of 2018.

In addition, we continue to investigate the cellular and molecular mechanisms of NK cells and macrophages by which CD16A-specific immune cell engaging antibodies eliminate tumor cells. We then expect to provide additional data on our research at a scientific or medical conference in the fourth quarter of 2018.

Another combination opportunity to harness innate and adaptive immunity is represented by our preclinical research collaboration with Nektar Therapeutics.

In June, Affimed entered into a preclinical research collaboration with Nektar Therapeutics, whereby the two companies intend to investigate the approach of combining Affimed’s NK cell engagers with Nektar’s cytokine-based products NKTR-214 and NKTR-255 to potentially achieve deeper clinical responses.

As a reminder, we already presented preclinical work where we investigated the effects of such cytokines on NK cells after engagement by immune cells and saw that this helps to expand the NK cells. Now, let's turn to Affimed seasonal targeting platform.

We see great opportunity with our differentiated proprietary formats, which are highly specific, have unique PK/PD profiles, and do not confer non-specific activation of T cells in the absence of target cells.

AFM11 is being developed to treat CD19-positive B cell malignancies, and we are evaluating safety and preliminary efficacy in two Phase 1 dose escalation studies in relapse refractory ALL and in relapse refractory NHL. Both studies are actively recruiting patients and dose escalation is ongoing.

The ALL study is currently recruiting into the sixth dose cohort and the NHL study is currently recruiting the fifth dose cohort. Again here, we plan to provide an update on AFM11 at a scientific or medical conference in the fourth quarter of 2018.

A second T cell engager based on our platform is being developed by Amphivena therapeutics to treat CD33-positive malignancies, such as AML, in a first in human Phase 1 dose escalation study. In June, Amphivena reported initial data from a Phase 1 study at EHA.

The data demonstrate that AMV564 engages and activates T cells, resulting in leukemic cytoreduction. Amphivena has also initiated a Phase 1 dose escalation study in myelodysplastic syndrome. As a reminder Affimed owns approximately 18.5% of Amphivena. Florian will now provide details on the financial figures.

Florian?.

Florian Fischer

Thank you, Adi. Affimed’s consolidated financial statements have been prepared in accordance with IFRS as issued by the International Accounting Standards Board, or IASB. The consolidated financial statements are presented in euros, which is the Company’s functional and presentation currency.

Therefore, all financial numbers that I will present here in this call, unless otherwise noted, will be in euros. Any numbers referring to Q2 2017 and Q2 2018 are unaudited. Cash and cash equivalents totaled €47.4 million as of June 30, 2018 compared to €39.8 million as of December 31, 2017.

The increase was primarily attributable to the net proceeds of €19.7 million from the public offering in February 2018, partially offset by Affimed’s operational expenses. Net cash used in operating activities was €15.2 million for the six months ended June 30, 2018 compared to €13.1 million for the six months ended June 30, 2017.

The increase was primarily related to higher cash expenditure for research and development in connection with Affimed’s clinical development programs. Affimed expects to have cash to fund its operations at least until the fourth quarter 2019.

This provides runway for the planned development of our clinical programs, as well as for further discovery and early development activities. Revenue for the second quarter 2018 was 200,000 compared to 500,000 for the second quarter 2017.

Revenue in the 2018 period was solely derived from AbCheck services, while revenue in the 2017 period relates to Affimed’s former collaboration with Amphivena and AbCheck service. R&D expenses for the second quarter 2018 were €7.1 million compared to €5.4 million for the second quarter of 2017.

The increase was primarily related to higher expenses for AFM13 and AFM11. G&A expenses for the second quarter 2018 were slightly higher at €2.2 million compared to €2 million for the second quarter of 2017.

Net loss for the second quarter of 2018 was nearly unchanged at €8 million or €0.13 per common share compared to a net loss of €7.9 million or €0.18 per common share for the second quarter 2017.

The increase of operating expenses was offset by finance income of €1.1 million in the second quarter 2018, whereas finance costs of €1.2 million was shown in the second quarter of 2017. Now, I’ll turn the call back over to Adi for concluding remarks.

Adi?.

Adi Hoess

Thanks, Florian. We continue to make progress with our key pipeline programs, both on the NK cell and T cell engager programs. In addition for NK cell engagers, we are exploring the combinations with checkpoints adoptive NK cell transfer and cytokines.

In this context, we have built an effort to going a deeper understanding of the molecular mechanisms, which differentiate our immune cell engagers from other approach. We’ve made particular progress in better understanding our engagers’ activation of innate immune cells to kill tumor cells.

We are on track with our development programs, and plan to report new data on a number of our clinical and preclinical programs at a scientific or medical conference in the fourth quarter of 2018.

Based on the promising AFM13 data that has been generated to-date, both as monotherapy and in combination, we are currently evaluating future clinical development plans for AFM13 in several indications, and continue to have discussions with clinical and regulatory experts to help inform our strategy.

In addition, we intend to initiate discussions with the FDA on potential expedited development pathway for AFM13. Thanks again everyone for joining us today. We appreciate you’re following our continued progress and look forward to speaking to you soon again. Thank you..

Operator

Ladies and gentlemen, this concludes today’s conference call. Thank you for your participation. You may now disconnect..

End of Q&A:.

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