Affimed NV (AFMD) 2019 Q4 法說會逐字稿

Good day, and welcome to Affimed's Fourth Quarter and Full Year 2019 Financial Results and Corporate Update Conference Call. (Operator Instructions) 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.

Thank you, Raffy. I'd like to welcome and thank everyone for joining us for Affimed's conference call to discuss the company's full year 2019 financial results and operational progress. This morning, Affimed issued a press release, which is posted on our website at www.affimed.com.

On the call today with prepared remarks are Adi Hoess, Chief Executive Officer of Affimed; Andreas Harstrick, Chief Medical Officer; and Michael Wolf, Head of Finance. We are also joined by Arndt Schottelius, Chief Scientific Officer; Wolfgang Fischer, Chief Operating Officer; and Denise Mueller, Chief Business Officer, who will be available for questions and answers.

We will begin today's call with opening remarks from Adi on our operational progress. Andreas will provide an update on our clinical program, and then Michael will review the financial results and update our financial guidance. After 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 section entitled Forward-Looking Statements in the press release that we issued today and filed with the SEC as an exhibit of the current report on Form 6-K.

And with that, I will now turn the call over to Adi.

Thanks a lot, Greg. And good morning, everyone, and thank you for joining us. The ongoing COVID-19 pandemic has been an unprecedented challenge to the health care community and our global society. Before I comment on Affimed's continued progress, I want to say a special thank you to our employees, investigators and clinical clients, patients and collaborators who have been strongly supportive during this difficult period and shown great resilience. And on behalf of everyone at Affimed, we're incredibly grateful to the health care workers around the world, who are delivering care for patients who are in the most need during this dynamic.

Despite these challenging times, we continue to make progress with our CD16A targeting innate cell engagers to enhance current immuno-oncology approaches, but we acknowledge the impact from the evolving COVID-19 pandemic on clinical studies, including potential delays in patient enrollment. Overall, we believe that the anticipated safety and efficacy features of our molecules could positively change the health of patients suffering from hematologic and solid tumor malignancies. We believe our lead innate cell engager, AFM13, could become a future treatment for patients with relapsed or refractory CD30-positive lymphoma, who have limited or no treatment options currently. Our second innate cell engager, AFM24 is designed to activate innate immunity to broadly target EGFR-expressing solid tumors regardless of mutational status and has the potential to improve efficacy and safety over currently available EGFR targeted therapy. In addition, we are leveraging our ROCK platform to generate additional novel molecule, enabling us to further deepen our pipeline and create partnering opportunities.

Now let's review our key progress in 2019 and recent months. We are continuing to advance AFM13 and AFM24, and our clinical trials currently remain active despite broad disruptions to clinical trial activity due to the COVID-19 pandemic. Just earlier this month, we announced that the first patient was successfully dosed in the first-in-human Phase I/IIA study of AFM24 for the treatment of advanced EGFR-expressing solid tumors, including colon, lung and other cancers. This is a major milestone for Affimed and for patients with solid tumors continue to progress, and marks the first time a patient with solid tumors has been dosed with an innate cell engager.

Regarding AFM13, we dosed the first patient in the fourth quarter of 2019 in our registration-directed Phase II study in relapsed or refractory CD30-positive peripheral T-cell lymphoma, or pTCL, and enrollment is ongoing. We announced earlier this month that the FDA granted orphan drug designation to AFM13 for the treatment of patients with T-cell lymphoma. AFM13 was previously granted orphan drug designation by the FDA for Hodgkin lymphoma.

Beyond AFM13 and AFM24, we are broadening our early-stage pipeline with additional innate cell engager from our ROCK platform, which we are developing internally and with Genentech. We broadened our early internal pipeline with 2 new CD16A binding innate cell engager candidates from our ROCK platform, which we call AFM28 and the AFM32. We plan to advance the first candidate into clinical studies this year with the aim of supporting future IND submissions.

Regarding our collaboration with Genentech in November 2019, Genentech exercised its final option for an exclusive target under the collaboration agreement. The target selection triggered a payment in an undisclosed amount to Affimed. The collaboration is ongoing, and we, along with Genentech, continue to progress multiple programs towards generating novel therapies that leverage the full potential of the innate immune system to help people living with cancer.

We have strengthened our executive management team with 2 recent key appointments that we're very excited about. In March, Dr. Andreas Harstrick joined Affimed as Chief Medical Officer. And in April, Dr. Arndt Schottelius joined the company as Chief Scientific Officer.

Andreas brings extensive experience in cancer drug development, including strategic leadership of 3 global Phase III programs of new biological entities that culminated in global regulatory approvals and multiple pivotal Phase III studies. He designed clinical trials that have led to approval of antibody drugs, including Erbitux, Portrazza, both which have EGFR; and Cyramza, a VEGFR2 antagonist.

Arndt, who joined us as CSO, has extensive innate immunity expertise, a unique background in building therapeutic antibody pipeline and a strong track record in advancing drugs through preclinical and development. Importantly, he has -- he also is seasoned in establishing productive collaborations that have led to increasing the value of his previous company. Arndt is taking over the preclinical discovery team from Wolfgang Fischer, who, for a year, led the team on an interim basis.

I wanted to express my gratitude to Wolfgang, who, together with his teams, brought AFM24 into the clinic, determine the activities for the generation of novel platform IP, started external collaborations that further deepened our understanding of innate immune cell activation in oncology and drove target identification, which was the basis for the generation of our preclinical programs, AFM28 and AFM32. With Arndt's and Andreas' appointments, we believe we are fully positioned to continue our leadership in innate immunity. Welcome to both, Andreas and Arndt.

Switching briefly to our cash position. We raised EUR 29.5 million in net proceeds from a public offering at -- public equity offering in November 2019. Based on our current operating plan and assumptions, we believe we have sufficient cash resources to build on our momentum and fund operations at least into the first half of 2022.

Let's turn to how Affimed has responded to the unprecedented challenges resulting from the COVID-19 pandemic. We are striving to balance our commitment to treat cancer patients and to mitigate the potential health and safety risks proposed by COVID-19. At the same time, we're also focused on supporting continuity of our operations and clinical trials as well as preserving our financial flexibility for the future. Our top priority during this challenging times continues to be protecting the health, safety and well-being of our employees, their families and communities.

In early March, we transitioned to a global work-from-home policy for most of our employees to limit the spread of COVID-19, following recommendations from local and national government and health care agencies. Our infrastructure allows for our remote workforce while also supporting our business continuity. I'm proud to say that our passionate team of professionals has adapted well, and we are currently operating without material disruption.

Meanwhile, laboratory activities at our facilities in Heidelberg continue to have been subject to heightened precautions, including social distancing and other measures to ensure the safety of our laboratory employees and the continuation of our preclinical research activities for our internal and Genentech partner programs. We continue to assess company policies, business continuity plans, employee support measures and will determine the appropriate time to resume in-office functions based on guidelines from local and national government and health agencies. Additional precautions that we have implemented include eliminating nonessential travel and promoting virtual or video meetings instead of in-person meetings in order to further protect the health and safety of our employees, patients and staff at the sites participating in our clinical study.

I will turn the call over to Andreas to provide more detail on our clinic programs and discuss what we are doing in response to COVID-19 to maintain continuity of our clinical trials. Andreas, please.

Yes. Thank you very much, Adi, for the introduction. And good morning to everybody. As you have heard, I joined the company roughly 8 weeks ago on March 1, and I'm really excited to be with Affimed and also to be with all of you on the call today.

So before we review the individual clinical programs of Affimed, let's start with a more general look on the COVID-19 pandemic and how Affimed is responding to this pandemic in the clinical programs. You're all aware that the COVID-19 pandemic is draining or taking significant amounts of health care resources from hospitals and health care providers in order to treat COVID-19 cases. And this, of course, impacts other functions of the hospitals and the health care systems, including the recruitment and the execution of clinical trials.

Here, at Affimed, we have taken a very individualized approach to handle the situation. And our 2 guiding principles are to maintain and secure patient safety, which is our #1 priority, and to make sure that the trial data integrity is maintained. Within this framework, we are working on an individual basis, basically with every single of our investigational sites and with every -- of our investigators to continue the enrollment of patients into our clinical trials because we believe that most of these patients have immediately life-threatening diseases, which is treatment-refractory cancers and that enrollment into a clinical trial is the best treatment option for these patients. Having said that, it is, I think, realistic to assume that the COVID-19 pandemic will have implications on previously published time lines. And I think it is impossible and would not be appropriate at this point in time to come up with concrete figures. However, we will update you as soon as we get a better vision on the impact of COVID-19 pandemic and how it evolves.

Furthermore, as mitigation steps and as logistics get more and more complex, we have taken steps to ensure that drug supply will be available for all patients that may be enrolled onto Affimed trials, and that other trial-related materials are ready and available for patients as well.

Now let's briefly turn to the individual programs, and I will start with the registration-directed Phase II study of AFM13 monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphomas. As Adi already mentioned, the patient enrollment in this study is ongoing, and we have successfully activated 42 clinical study sites across 9 countries. Remember that the main patient population of this study are patients with treatment refractory peripheral T-cell lymphoma, patients that have very limited treatment options and a poor survival. So we are meeting here an area of significant unmet medical need.

You may also recall that this study had an observation cohort for patients with CD30-positive relapsed/refractory cutaneous T-cell lymphomas, mainly mycosis fungoides or transformed mycosis fungoides. Now as this observation cohort is not part of the registration-directed efforts, we have decided to temporarily stop enrollment into this observation cohort while the enrollment into the registration-directed cohort is ongoing. We believe that the results of this Phase II study in peripheral T-cell lymphoma, if positive, could form the basis for the BLA application and could possibly support an accelerated approval process for AFM13 in this unmet medical situation.

Next, I will briefly turn to the planned Phase I study, which is intended to evaluate AFM13 in combination with cord blood-derived allogeneic natural killer cells in cooperation with the MD Anderson Cancer Center in Houston. Again, the targeted patient population would be relapsed/refractory CD30-positive lymphoid malignancies. We are in close collaboration with MD Anderson to initiate this study, and GMP process validation continues at this time. As this is an investigator-sponsored trial and MD Anderson is also affected by the COVID-19 situation, it is currently not possible to come up with an exact start date for first patient enrollment.

Let's move on to our second compound, AFM24. And as you have seen from my biography, I have been working EGFR for the best part of my industry career. So this is a drug that gets me really excited. AFM24 is a tetravalent bispecific EGFR and CD16A binding innate cell engager. It has a very novel mechanism of action as it is activating the immune -- innate immune system to kill solid tumors, affecting both antibody-dependent cellular cytotoxicity as well as antibody-dependent cellular phagocytosis. I think it's also important to note that this approach is very different from the currently available EGFR targeting therapies, which all functioned by the disruption of the EGFR signaling pathway. Now AFM24's mechanism of action is completely independent of EGFR signaling, and therefore, it is likely that it will be or can be active in patients who have developed resistance, for example, by RAS mutation to this classical EGFR targeting drugs.

Earlier this month, we announced that we enrolled the first patient into our first Phase I/IIA study of AFM24. We're successfully dosing at the USC Norris Comprehensive Cancer Center. I think this is a very significant achievement that we were able to initiate this study in this challenging times. And it may also show how investigators see the potential of this drug, and we are looking forward for continuing this study with this novel agent to further validate safety and efficacy.

In terms of publications, we had intended to share new data from 2 of our ongoing programs during the poster session of AACR. However, due to the COVID-19 pandemic, as you're all aware, AACRs now be held virtually in 2 different meetings, and we expect to share some of the data in the second virtual meeting being held in June.

Another meeting was also canceled, the Innate Cell Engager Summit, where we had planned to publish additional data showing activity or showing results with our innate cell engagers in combination with NK cell products. We have not determined when this update can be presented. But in general, we intend to provide continued update on our progress at future conferences.

With that, I conclude my overview over the clinical programs and hand over to Michael for the financial overview. Michael?

Thank you, Andreas. Affimed's consolidated financial statements have been prepared in accordance with IFRS as issued by the International Accounting Standard Board, or IASB. The consolidated financial statements has -- 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.

We ended 2019 with EUR 104.1 million in cash, cash equivalents and current financial assets as compared to EUR 108.8 million as of December 31, 2018. During the fourth quarter of 2019, we completed a public equity offering with net proceeds of EUR 29.5 million. Based on our current operating plan and budget assumptions, we anticipate that our cash position as of December 31, 2019, will enable us to fund our planned clinical development and early development activities, at least into the first half of 2022.

Net cash used in operating activities for the 12 months ended December 31, 2019, was EUR 29.1 million compared to net cash from operating activities for 12 months ended December 31, 2018, of EUR 49.4 million. The net cash from operating activities in 2018 includes an initial upfront payment and committed funding of EUR 83.2 million or $96 million from the strategic collaboration Affimed entered into with Genentech in August 2018.

Total revenue was EUR 21.4 million for the year ended December 31, 2019, compared to EUR 23.7 million for the year ended December 31, 2018. Revenue in both 2019 and '18 is attributable primarily to the recognition of revenue from the Genentech collaboration in the respective years.

R&D expenses for the full year of 2019 were EUR 43.8 million compared to R&D expenses for the full year of 2018 of EUR 35.1 million. The increase was primarily related to higher expenses for start-up activities for the AFM13 registration-directed study in pTCL, manufacturing activities for AFM13 clinical study material and early stage development and discovery activities.

G&A activities -- sorry, G&A expenses for the full year of 2019 were EUR 10.3 million compared to EUR 9.6 million for the full year of 2018. Net loss was EUR 32.4 million or EUR 0.50 per common share for the full year 2019 compared to a net loss of EUR 19.5 million or EUR 0.32 per common share for the full year of 2018. Weighted number of common shares outstanding were 64.2 million for the year ended December 31, 2019.

And with that, I would like to turn the call back over to Adi for closing comments before we open up the call to questions. Adi?

Thanks a lot, Michael. So our differentiated CD16A binding innate cell engagers could transform current immuno-oncology approaches by indeed actualizing the untapped potential of the innate immune system with the intention to give back patients their innate ability to fight cancer. Throughout the ongoing COVID-19 pandemic, Affimed remains committed to keeping employees and their families safe to reduce the spread of the virus. We also remain committed to continuing to advance our novel and differentiated innate cell engagers in order to bring our drugs to patients.

We will now be happy to address any questions that callers may have. Operator?

(Operator Instructions) Your first question comes from the line of Jay (sic) [Jim] Birchenough.

Congratulations on the great hires with Andreas and Arndt. Just a few questions. I guess just starting with the discontinuation of the cutaneous T-cell lymphoma observational cohort, were you able to observe enough patients to have a comment on activity? Did it confirm the activity of the drug before the discontinuation? Just trying to understand a bit better of what you saw before discontinuing that cohort. Certainly, I understand the rationale, but I just want to understand what you saw before discontinuing that cohort.

Andreas, you want to take that question, please?

Yes, I can take this. So the -- we have not completely discontinued this cohort, I think that's important to state. We have temporarily stopped or ceased enrollment into this cohort. And the reason for that is that patients with cutaneous T-cell lymphomas, the assessment of responses is quite complex and usually require several trips of the patient to the hospital taking whole body photographs and measurements, which we thought, in the current COVID-19 pandemic, would not be appropriate to have a patient go to the hospital several times. So we have temporary put enrollment on hold. Again, I think it's important to realize that this was not part -- or is not part of the initial registration strategy. The registration cohort or the registration population would be peripheral T-cell lymphoma, so not cutaneous T-cell lymphoma. And as soon as the COVID-19 pandemic resolves and we are getting better access to health care resources, our intention would be to reopen enrollment into this.

And then, Andreas, maybe given your background with EGFR-directed therapies, could you give us your thoughts on positioning of AFM24, where you see it best positioned within the EGFR landscape? Is it following progression on antibodies and TKIs or in place of those or expanding into new indications where we don't have current therapies?

Yes. Thank you for that question. And again, that gets me excited. I think it will be part of all the options that you mentioned. Again, AFM24 has a completely different mechanism of action. So in order to work, it does not require that the cell is actively using the EGFR signaling pathway, which is very different from TKIs or antibodies that mainly work or basically exclusively work in tumors that are, if you will, EGFR signaling addicted. So here, because we have a completely different mechanism of action where EGFR as a receptor is not the real target in itself, it's more like a mailbox address that brings innate immunity, the NK cells and the macrophages, into the tumor microenvironment. So we would see clearly a position of AFM24 in indications, EGFR-expressing tumors that do not respond to other antibodies or TKIs. Many of these tumors have downstream mutations, I think the most relevant or the most well-known is the RAS mutation in colorectal cancer that affects about 40% to 50% of all colorectal cancers. So this would be clearly a possible indication where EGFR targeting agents are not approved or there are other areas, if you can think about, like ovarian cancer or other tumors that have a reasonably high expression rate of EGFR.

And then further down the line, you can think either of sequential treatments in those indications where EGFRs are approved. You could also think, even if you think about TKIs, for example, EGFR-mutated non-small cell lung cancer, again, either bring the innate immune system into these tumors prior to TKI treatment, after TKI treatment, and in some cases, you may even want to combine with TKI treatment. So I think there are a lot of opportunities in tumors that do not classically respond to EGFR because they have resistance referring mutations. And then also in tumor set could respond to an EGFR inhibiting drug, but also express EGFR as a mailbox address. We are assuming that AFM24, and we have seen this, for example, in our mighty toxicity study may have a better safety profile, especially since it does not disrupt the EGFR signaling, it may have less skin toxicity. So again, a very broad field of development opportunities and where this drug really could make an impact.

And maybe just one final one before I jump back in the queue. On AFM28 and 32, I don't think you've disclosed the target. Should we expect to learn the target when you move into clinic? Is there any preclinical data that we should expect this year? Just trying to get a sense of when we'll get some visibility on one or both of those targets.

Yes. I'll jump in here quickly. Thanks, Jim, for asking this. So as we've said previously, we have not decided yet when to publish these targets. Both molecules are progressing, and as I mentioned before, we anticipate an IND filing in the -- for the first drug towards the end of 2021. The main driver for us, yet to keep it confidential to Affimed, is the data that we're currently generating, obviously, generating novel. So this IP securing experiments are ongoing. And once we have completed those experiments, we can then share the indications and the nature of the targets. But as I said, currently, we have not decided when that would be.

Your next question comes from Maury Raycroft.

This is Kevin Strang in for Maury. I just had a couple of quick questions. First, I was wondering if you could provide any sort of general update on the first AFM24 patient that was dosed. Is there anything on-patient baseline characteristics and how the patient is doing after dosing?

Andreas, can you please take that question?

Yes. We have -- so we updated some EGF patient with an EGFR-expressing tumor refractory to standard of care, and the patient is doing fine after dosing.

I think we cannot give more detailed update at this point in time.

Okay. And for the AFM13 registrational study in pTCL, could you comment on how enrollment is going in terms of CD30 expression? Are you generally finding that you have more patients with higher or lower CD30 expression?

Yes. So the CD30 expression, I think, in this study, is in line with previously published data. As you know, we are accepting every patient with a CD30 expression of at least 1%. And we see a fairly even distribution of CD30 expression from rather low expressers to rather high expressers. So it's a continuum. We do not see a real clustering of either very high or very low expressers.

Your next question comes from the line of I-Eh Jen.

Hello?

We can hear you.

Okay. Sorry about that. Just a quick question here. First of all, in terms of the pTCL study, initially, there's a plan for internal analysis. Is that still on the schedule? And any colors on that?

Andreas, again, a question for you.

I did not get the full question. Is it around the interim analysis?

Yes. It's about 20 patients, I think the initial 20 patients, and you will have a first look at that before -- while you continue enrolling patients for up to 120. So that's the interim analysis, I was referring.

Yes. The interim analysis is still planned. However, in terms of time lines, I think it falls under what has been discussed already around the COVID-19 pandemic. We have to expect a delay, but we cannot quantify how significant or how big this delay will be. And as soon as we get a little bit better clarity about the enrollment kinetics, I think we will provide you with updated information.

Okay. Great. That's very helpful. And just one more follow-up question here, which is in terms of AFM24. Congrats, you have dosed the first patient. And up to now, do you still -- do you have additional patients being dosed or still under screening at this point?

We have 2 sites opened. So we also were able to initiate a second site, which I think is another good achievement. As you know, this is a dose escalation study with different cohorts. So we currently are open for additional patients. And as I said, we will update as we go along, but 2 sites are open and could potentially enroll patients.

Okay, great. And maybe just sneaking one more question here, which is, is there any plan at this moment to have some presentation either at ASCO or maybe even at ASH for this year? Or it's too early to speculate at this point?

Yes, yes, that's too early to speculate. So we are, indeed, what we said before, we are now evaluating which conferences are happening, which formats they have, and then we can decide on our way forward, on which data we're going to publish, but we are committed to present updates. And the next ones to happen are at the virtual AACR, where we should have -- it's planned to have to post us. Now we'll see how that all goes and what the benefit is, and then we can decide further on how to move ahead.

Thank you.

(Operator Instructions) Your next question comes from the line of Daina Graybosch.

This is Dilip sitting in for Daina. We just want to know for the Phase II trial of AFM13, are you seeing disruption across all activated sites? Or is there more of a regional impact to recruitment?

Again, Andreas, it's a question for you, please.

I think I can take that. This is what I previously mentioned, we are taking a very individualized approach and basically being in contact with every single site. There is no general pattern, so it is really site-by-site specific. Just to give you a short anecdote when the whole COVID crisis started out 6 weeks or so ago, Italy, clearly, was the country that was mostly affected, and we would in fact expect that we will not see recruitment from Italy. And in fact, one of the very next patients came from Italy, where a site was still able to enroll patients into a study and ensure patient safety and data integrity. So it is really a site-by-site situation changing constantly. And we see sites temporarily not being able to enroll patients, other sites coming back and enrolling patients. So it's really a very, very individualized picture, and I think it's important to stay in contact with each individual investigator to manage as good as you can in this to minimize the delays as much as possible.

And could you confirm or provide some clarity on the number of patients that have been enrolled thus far?

Could you repeat the question, please?

Just some clarity on the number of patients that have been enrolled thus far.

I think we are not giving concrete patient numbers at this point in time. So we were seeing enrollment, but I can not give you a concrete number.

I think Dilip got disconnected, correct?

We have no further questions. Please continue, Adi. Thank you.

Yes. If there are no further questions, I wanted to thank you for taking the time to join us today and for the continued interest and support of Affimed. We look forward to speaking with you again on the very next update calls, and I wish you a safe and healthy time during this COVID pandemic and that anybody can live under these circumstances, which had turned us into a virtual life a little bit. But what we're seeing at Affimed, it can be effectively managed and the health of our employees, which is truly important to us, and the business continuity could be preserved. So thanks a lot, again, for this -- for your attendance at the earnings call. Have a nice day. Goodbye.

Ladies and gentlemen, that does conclude our conference call for today. Thank you for participating. You may all disconnect.